CANDO-3: Body composition and chemotherapy toxicity in women with early breast cancer
| ISRCTN | ISRCTN79577461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79577461 |
| IRAS number | 263666 |
| Secondary identifying numbers | IRAS 263666, RHMCAN1491 |
- Submission date
- 08/07/2020
- Registration date
- 27/07/2020
- Last edited
- 28/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Some patients with early breast cancer are treated with chemotherapy before or after surgery to remove the tumour from the breast. This chemotherapy is given with the aim of eradicating any cancer cell that have already escaped into the general circulation and therefore reduce the risk of the cancer returning in the future. Chemotherapy treatment in this setting is most effective if patients receive the optimum dose of chemotherapy on time without delays in their treatment or reductions in their chemotherapy doses. Chemotherapy doses are currently calculated from a patient’s height and weight. However, these calculations were designed for normal weight patients and this has resulted in uncertainty as to whether obese patients are being dose with chemotherapy correctly. We know that approximately 26% of British women are considered to be obese and that obese breast cancer patients have a higher risk of disease recurrence than healthy-weight patients. A review by the American Society of Oncologists suggested that oncologists may underdose obese patients and our own data suggests that some obese patients may be more at risk of experiencing severe side effects from chemotherapy than healthy weight patients, resulting in treatment delays.
Obesity is defined by body mass index which is also a calculation from height and weight and does not take into account the fact that people of the same size can have different amounts of blood, muscle and fatty tissue which can all affect the behaviour of drugs. Detailed assessments of lean and fat patterns, (body composition), can now be obtained within a few minutes using a technique called bioelectrical impedance analysis (BIA). Our pilot study, CANDO-2, has confirmed that data on the body composition of early breast cancer patients attending routine chemotherapy out-patients can be collected quickly and easily by asking patients to stand on a segmental BIA analyser for a few minutes after they have undergone their usual weight measurement, and that these measurements may help predict when patients might need to unexpectedly return to hospital during chemotherapy for side effects or problems. In this study we will be collecting body composition data from over 300 women receiving routine chemotherapy before or after breast surgery across several hospital sites in the UK. We will collect information for each patient about the chemotherapy drugs and doses they receive and the side effects they experience to investigate how different patterns of body composition affect response to chemotherapy.
Who can participate?
Women aged 18-80 with a diagnosis of early breast cancer, planned to receive greater than four 21-day cycles day cycles of anthracycline or taxane-based combination chemotherapy.
What does the study involve?
Each time the participant attends an oncology clinic prior to each chemotherapy treatment we will ask them to step onto the Seca medial Body Composition Analyser for a bioelectrical impedance test. The participant will also have their grip strength measured each time they come to clinic. Additionally they will be asked to complete short quality of life and lifestyle questionnaires on how they have been feeling in the weeks since the previous visit. These questionnaires will be completed at visit 1 (5 questionnaires), visit 4 (4), the 2- to 6-week follow-up and the 3-month follow-up.
Chemotherapy toxicity assessment will be performed at visits 2-8, (depending on how many chemotherapy cycles), and at follow-ups at week 2-6 and 3 months. The reviewing doctor or specialist nurse will record toxicities from the previous cycle of chemotherapy according to the NCI Common Toxicity Criteria (version 5.0) in a study clinical report form.
What are the possible benefits and risks of participating?
There are no particular risks involved in taking part in this study. The bioelectrical impedance test using the Seca mBCA515 and the measurements of grip strength will be painless but will take approximately 20 minutes to do. The questionnaires will take approximately 20 minutes to complete.
In terms of benefits, we hope this study will help us to understand whether differences in body composition can effect the severity of side effects from chemotherapy that patients experience, or the effectiveness of this treatment for breast cancer. It will not benefit participants personally but it is hoped that the knowledge gained from this project will help improve the care of women with breast cancer in the future.
Where is the study run from?
The study is a University of Southampton study with Southampton as the host site. University Hospital Southampton is the sponsor.
When is the study starting and how long is it expected to run for?
The study opened to recruitment in Southampton on March 16th 2020. It was immediately suspended by the sponsor due to the COVID-19 pandemic. The study has now reopened in Southampton and the other sites are expected to open sequentially over the next 3 months.
There will be an 18-month recruitment period for each site. The study will be expected to end in February 2025.
Who is funding the study?
The study has received funding from the World Cancer Research Fund.
Who is the main contact?
Dr Kesta Durkin, k.l.durkin@soton.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-the-structure-of-the-body-and-how-it-affects-treatment-side-effects-cando-3
Contact information
Public
Southampton Centre for Biomedical Research
Level E, South Academic Block, (MP 113)
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2381204578 |
|---|---|
| K.L.Durkin@soton.ac.uk |
Scientific
Cancer Research UK Centre
Somers Cancer Research Building
MP 824
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0002-1719-7255 |
|---|---|
| Phone | +44 (0)23 8120 4946 |
| R.I.Cutress@soton.ac.uk |
Study information
| Study design | A multi-centre observational (non-interventional) investigator-led academic prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet |
| Scientific title | The CANDO-3 study: Body composition and chemotherapy toxicity in women with early breast cancer |
| Study acronym | CANDO-3 |
| Study objectives | Differences in bioelectrical impedance measures of resistance, reactance and phase angle and/or derived estimates of low FFMi and elevated FMi, are individually and jointly predictive of chemotherapy toxicity. |
| Ethics approval(s) | Approved 30/01/2020, Hampshire B ethics committee (Level 3 Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; +44 (0)207 104 8054; hampshireb.rec@hra.nhs.uk), ref: 19/SC/0596 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Current interventions as of 26/04/2023: At diagnosis 300 women with early breast cancer will be recruited from across several hospital sites and studied prior to, during and after chemotherapy treatment. All patients will be consented prior to their first chemotherapy treatment and receive chemotherapy regimens and usual care as determined by their attending physician using current best practice guidelines to prescribing. Body composition and impedance measures (resistance, reactance and Phase Angle will be assessed using a phase-sensitive 8-electrode segmental Bioelectrical Impedance Analysis (sBIA) device (Seca medical Body Composition Analyser 515 [mBCA]) prior to each cycle of chemotherapy (4-8 visits and at follow-ups 2-6 weeks and 3 months). Grip strength will also be tested at each study visit. Body composition will also be determined, where available from analysis of staging CT scans (where performed as part of routine clinical care. Chemotherapy side effects will be recorded according to the NCI Common Toxicity Criteria (version 5.0, Nov 17). In those receiving neo-adjuvant chemotherapy, pathological complete response (pCR) rates will be determined. Previous interventions as of 23/09/2021 to 09/11/2021: At diagnosis 300 women with early breast cancer will be recruited from across several hospital sites and studied prior to, during and after chemotherapy treatment. All patients will be consented prior to their first chemotherapy treatment and receive chemotherapy regimens and usual care as determined by their attending physician using current best practice guidelines to prescribing. Body composition and impedance measures (resistance, reactance and Phase Angle will be assessed using a phase-sensitive 8-electrode segmental Bioelectrical Impedance Analysis (sBIA) device (Seca medical Body Composition Analyser 515 [mBCA]) prior to each cycle of chemotherapy (4-8 visits and at follow-ups 2-6 weeks and 3 months). Grip strength will also be tested at each study visit. Body composition will also be determined, where available from analysis of staging CT scans (where performed as part of routine clinical care. Chemotherapy side effects will be recorded according to the NCI Common Toxicity Criteria (version 5.0, Nov 17). In those receiving neo-adjuvant chemotherapy, pathological complete response (pCR) rates will be determined. In the Southampton mechanistic optional sub-study only, body composition will be also determined by Dual-energy x-ray absorptiometry (DXA) and bloods will be taken for further analysis. Previous interventions as of 23/09/2021: At diagnosis 300 women with early breast cancer will be recruited from across 7 hospital sites and studied prior to, during and after chemotherapy treatment. All patients will be consented prior to their first chemotherapy treatment and receive chemotherapy regimens and usual care as determined by their attending physician using current best practice guidelines to prescribing. Body composition and impedance measures (resistance, reactance and Phase Angle will be assessed using a phase-sensitive 8-electrode segmental Bioelectrical Impedance Analysis (sBIA) device (Seca medical Body Composition Analyser 515 [mBCA] prior to each cycle of chemotherapy (4-8 visits and at follow-ups (3 weeks and 3 months. Grip strength will also be tested at each study visit. Body composition will also be determined, where available from analysis of staging CT scans (where performed as part of routine clinical care. Chemotherapy side effects will be recorded according to the NCI Common Toxicity Criteria (version 5.0, Nov 17). In those receiving neo-adjuvant chemotherapy, pathological complete response (pCR) rates will be determined. In the Southampton mechanistic optional sub-study only, body composition will be also determined by Dual-energy x-ray absorptiometry (DXA) and bloods will be taken for further analysis. Previous interventions: At diagnosis 300 women with early breast cancer will be recruited from across 7 hospital sites and studied prior to, during and after chemotherapy treatment. All patients will be consented prior to their first chemotherapy treatment and receive chemotherapy regimens and usual care as determined by their attending physician using current best practice guidelines to prescribing. Body composition and impedance measures (resistance, reactance and Phase Angle will be assessed using a phase-sensitive 8-electrode segmental Bioelectrical Impedance Analysis (sBIA) device (Seca medical Body Composition Analyser 515 [mBCA] prior to each cycle of chemotherapy (4-8 visits and at follow-ups (3 weeks and 3 months. Grip strength will also be tested at each study visit. Body composition will also be determined, where available from analysis of staging CT scans (where performed as part of routine clinical care. Chemotherapy side effects will be recorded according to the NCI Common Toxicity Criteria (version 5.0, Nov 17). In those receiving neo-adjuvant chemotherapy, pathological complete response (pCR) rates will be determined. In the Southampton mechanistic optional sub-study only, body composition will be also determined by Dual-energy x-ray absorptiometry (DXA). Peak VO2 and Anaerobic Threshold (AT) will be determined by cardiopulmonary exercise testing (CPET) and bloods will be taken for further analysis. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 09/11/2021: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (2-6 weeks and 3 months): 1. FMi determined by sBIA using the Seca mBCA 515 2. Chemotoxicity reporting according to the NCI Common Toxicity Criteria (version 5.0, Nov 17) Previous primary outcome measure: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (3 weeks and 3 months): 1. FMi determined by sBIA using the Seca mBCA 515 2. Chemotoxicity reporting according to the NCI Common Toxicity Criteria (version 5.0, Nov 17) |
| Secondary outcome measures | Current secondary outcome measures as of 26/04/2023: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (2-6 weeks and 3 months) unless otherwise stated: 1. Grip strength using JAMAR hydraulic hand dynamometer at every study visit 2. sBIA to measure bioelectrical properties and body composition using the Seca mBCA 515 at every study visit 3. Quality of life and lifestyle using validated questionnaires: At visit 1: AUDIT-C, EORTC QLQC30, EORTC QLQ-BR23, IPAQ-SF and CNAQ. At visit 4, and at follow-ups 3 weeks and 3 months: EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ 4. Chemotoxicity assessments according to the standardised NCTAE v5.0 criteria: At every study visit (APART FROM VISIT 1) 5. If and when clinically indicated body composition by sliceomatic analysis from routine care CT scans: This would usually be prior to commencement of chemotherapy but timings may be variable. Previous secondary outcome measures as of 23/09/2021 to 09/11/2021: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (2-6 weeks and 3 months) unless otherwise stated: 1. Grip strength using JAMAR hydraulic hand dynamometer at every study visit 2. sBIA to measure bioelectrical properties and body composition using the Seca mBCA 515 at every study visit 3. Quality of life and lifestyle using validated questionnaires: At visit 1: AUDIT-C, EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ. At visit 4, and at follow-ups 3 weeks and 3 months: EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ 4. Chemotoxicity assessments according to the standardised NCTAE v5.0 criteria: At every study visit (APART FROM VISIT 1) 5. If and when clinically indicated body composition by sliceomatic analysis from routine care CT scans: This would usually be prior to commencement of chemotherapy but timings may be variable As part of the optional Southampton mechanistic sub-study only: 6. Body composition by DXA using a Lunar Hologic scanner at visit 1 and at End of Study visit 7. One blood sample taken for biobanking at visit 1, visit 4, and at follow-ups 3 weeks and 3 months Previous secondary outcome measures as of 23/09/2021: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (3 weeks and 3 months) unless otherwise stated: 1. Grip strength using JAMAR hydraulic hand dynamometer at every study visit 2. sBIA to measure bioelectrical properties and body composition using the Seca mBCA 515 at every study visit 3. Quality of life and lifestyle using validated questionnaires: At visit 1: AUDIT-C, EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ. At visit 4, and at follow-ups 3 weeks and 3 months: EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ 4. Chemotoxicity assessments according to the standardised NCTAE v5.0 criteria: At every study visit (APART FROM VISIT 1) 5. If and when clinically indicated body composition by sliceomatic analysis from routine care CT scans: This would usually be prior to commencement of chemotherapy but timings may be variable As part of the optional Southampton mechanistic sub-study only: 6. Body composition by DXA using a Lunar Hologic scanner at visit 1 and at End of Study visit 7. One blood sample taken for biobanking at visit 1, visit 4, and at follow-ups 3 weeks and 3 months Previous secondary outcome measures: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (3 weeks and 3 months) unless otherwise stated: 1. Grip strength using JAMAR hydraulic hand dynamometer at every study visit 2. sBIA to measure bioelectrical properties and body composition using the Seca mBCA 515 at every study visit 3. Quality of life and lifestyle using validated questionnaires: At visit 1: AUDIT-C, EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ. At visit 4, and at follow-ups 3 weeks and 3 months: EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ 4. Chemotoxicity assessments according to the standardised NCTAE v5.0 criteria: At every study visit (APART FROM VISIT 1) 5. If and when clinically indicated body composition by sliceomatic analysis from routine care CT scans: This would usually be prior to commencement of chemotherapy but timings may be variable As part of the optional Southampton mechanistic sub-study only: 6. Body composition by DXA using a Lunar Hologic scanner at visit 1 and at End of Study visit 7. Anaerobic threshold and peak VO2 using the LoveMedical ErgostikTM CPET System at visit 1 and at End of Study visit 8. One blood sample taken for biobanking at visit 1, visit 4, and at follow-ups 3 weeks and 3 months |
| Overall study start date | 01/03/2019 |
| Completion date | 28/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Female |
| Target number of participants | 300 |
| Total final enrolment | 300 |
| Key inclusion criteria | Current inclusion criteria as of 26/04/2023: 1. Early invasive breast carcinoma 2. Stage I-III disease 3. Tumour grade, ER and HER 2 status available 4. Clinical or pathological tumour size and lymph node status available 5. Neo-adjuvant or adjuvant systemic chemotherapy recommended by local breast multidisciplinary meeting 6. No prior systemic anti-cancer treatment within the past 10 years (hormonal therapy started since current breast cancer diagnosis (e.g. neoadjuvant or bridging endocrine therapy allowed) 7. No evidence of distant metastatic disease 8. Patient agrees to receive neo/adjuvant chemotherapy 9. Planned to receive greater than 4 x 21-day cycles of anthracycline or taxane-based combination chemotherapy. 21-day combination regimens including weekly treatments are allowed e.g. 1. carboplatin D1/paclitaxel D1, D8, D15 2. EC-weekly paclitaxel. Patients planned to receive the anthracycline component of the chemotherapy regimen at 2-weekly intervals (accelerated regimens) are additionally eligible for inclusion 10. Aged ≥18 years and <80 years 11. Female 12. Able to complete written records in English Previous inclusion criteria as of 27/07/2021 to 24/08/2021: 1. Early invasive breast carcinoma 2. Stage I-III disease 3. Tumour grade, ER and HER 2 status available 4. Clinical or pathological tumour size and lymph node status available 5. Neo-adjuvant or adjuvant systemic chemotherapy recommended by local breast multi-disciplinary meeting 6. No prior systemic anti-cancer treatment within the past 10 years 7. No evidence of distant metastatic disease 8. Patient agrees to receive neo/adjuvant chemotherapy 9. Planned to receive greater than 4 x 21-day cycles of anthracycline or taxane-based combination chemotherapy. 21-day combination regimens including weekly treatments are allowed e.g. 1. carboplatin D1/paclitaxel D1, D8, D15 2. EC-weekly paclitaxel 10. Aged ≥18 years and <80 years 11. Female 12. Able to complete written records in English Previous inclusion criteria as of 27/07/2021: 1. Early invasive breast carcinoma 2. Stage I-III disease 3. Tumour grade, ER and HER 2 status available 4. Clinical or pathological tumour size and lymph node status available 5. Neo-adjuvant or adjuvant systemic chemotherapy recommended by local breast multi-disciplinary meeting 6. No prior systemic anti-cancer treatment 7. No evidence of distant metastatic disease 8. Patient agrees to receive neo/adjuvant chemotherapy 9. Planned to receive greater than 4 x 21-day cycles of anthracycline or taxane-based combination chemotherapy. 21-day combination regimens including weekly treatments are allowed e.g. 1. carboplatin D1/paclitaxel D1, D8, D15 2. EC-weekly paclitaxel 10. Aged ≥18 years and <80 years 11. Female 12. Able to complete written records in English Previous inclusion criteria: 1. Early invasive breast carcinoma 2. Stage I-III disease 3. Tumour grade, ER and HER 2 status available 4. Clinical or pathological tumour size and lymph node status available 5. Neo-adjuvant or adjuvant systemic chemotherapy recommended by local breast multi-disciplinary meeting 6. No prior systemic anti-cancer treatment 7. No evidence of distant metastatic disease 8. Patient agrees to receive neo/adjuvant chemotherapy 9. Planned to receive 4-6 21 day cycles of anthracycline or taxane-based combination chemotherapy 10. Aged ≥18 years and <80 years 11. Female 12. Able to complete written records in English |
| Key exclusion criteria | Current participant exclusion criteria as of 11/02/2022: 1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) within the past 10 years 2. Any other medical conditions preventing physical participation in the study procedures 3. Patients receiving only single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab 4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies 5. Pregnancy 6. Pacemakers Previous exclusion criteria as of 24/08/2021: : 1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) within the past 10 years 2. Any other medical conditions preventing physical participation in the study procedures 3. Patients receiving only single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab 4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies 5. Pregnancy Previous exclusion criteria as of 27/07/2021: 1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) 2. Any other medical conditions preventing physical participation in the study procedures 3. Patients receiving only single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab 4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies 5. Pregnancy Previous exclusion criteria: 1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) 2. Any other medical conditions preventing physical participation in the study procedures 3. Patients receiving single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab 4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies 5. Pregnancy |
| Date of first enrolment | 16/03/2020 |
| Date of final enrolment | 31/05/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Salisbury
SP2 8BJ
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Department of Medical Oncology – Breast Team
Wilmslow Road
Manchester
M20 4BX
United Kingdom
Barrack Road
Exeter
EX2 5DW
Exeter
EX2 5DW
United Kingdom
Old Road
Oxford
OX3 7LE
United Kingdom
Treliske
Truro, Cornwall
TR1 3LJ
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department
E level, SCBR, MP 138
Southampton General Hospital
Southampton
SO16 6YD
England
United Kingdom
| Phone | +44 (0)23 81205664 |
|---|---|
| sponsor@uhs.nhs.uk | |
| Website | http://www.uhs.nhs.uk/home.aspx |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Charity
Private sector organisation / International organizations
- Alternative name(s)
- WCRF International, WCRF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The chief and co-investigators will be responsible for publication of the study findings in a peer-reviewed journal, on behalf of all collaborators. The manuscript will be prepared by a writing group, and participating investigators will be selected to join the writing group on the basis of contribution and following standard protocols for authorship. All participating clinicians will be acknowledged in the publication. A statement thanking study participants for their participation will be included in the study publication. Manuscripts, abstracts and publications will also include an acknowledgement of funding bodies. The University Hospital Southampton NHS Trust Foundation (UHS) and University of Southampton will appear as affiliates in all submissions and publications. |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Prof Ramsey Cutress via Dr Kesta Durkin. Anonymous data will be available for request from three months after publication of the article until the end of the archive and storage period described below. It will be available to researchers who provide a completed Data Sharing request form that describes a methodologically sound proposal, for the purpose of the approved proposal and if appropriate, signed a Data Sharing Agreement. Proposals will be reviewed by the study steering committee. Data will be shared once all parties have signed relevant data sharing documentation, covering the study steering committee conditions for sharing and if required, an additional Data Sharing Agreement from Sponsor. Proposals should be directed to the chief investigator. Following the close of the study, collection, analyses and reporting of data, the research data generated by this study will be archived and stored for 15 years in line with the Data Protection procedures that govern all research at the University of Southampton: data will be collected and retained in accordance with the General Data Protection Regulations 2018 in compliance with Caldicott principles. Point 9 of the CANDO-3 study participant consent form states: “I understand that the information collected about me will be used to support other research in the future and may be shared anonymously with other researchers”. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 22/02/2022 | 20/09/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
28/02/2025: The total final enrolment was added.
09/02/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/02/2024 to 31/05/2024.
2. The overall end date was changed from 30/11/2024 to 28/02/2025.
3. The plain English summary was updated to reflect these changes.
12/12/2023: Cancer Research UK plain English summary link added to plain English summary field.
23/08/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2023 to 29/02/2024.
2. The overall end date was changed from 31/05/2024 to 30/11/2024.
3. The plain English summary was updated to reflect these changes.
26/04/2023: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/06/2023 to 31/05/2024 and the plain English summary has been updated to reflect the change.
2. The intention to publish date has been changed from 01/03/2023 to 31/05/2025.
3. The inclusion criteria were changed.
4. The interventions were changed.
5. The secondary outcome measures were changed.
6. The recruitment end date has been changed from 30/06/2023 to 31/08/2023.
7. Trial participating centre Royal Hampshire County Hospital has been removed
20/09/2022: Publication reference added.
17/02/2022: The plain English summary has been updated to reflect the current follow-up schedule.
11/02/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/07/2022 to 30/06/2023.
2. The trial participating centre "Leeds Teaching Hospitals NHS Trust" has been added.
3. The participant exclusion criteria has been updated.
09/11/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/11/2022 to 30/06/2023.
2. The interventions were changed.
3. The primary outcome measure was changed.
4. The secondary outcome measures were changed.
5. The trial participating centre John Radcliffe Hospital was changed to Churchill Hospital, and Royal Cornwall Hospital was added.
6. The plain English summary was updated to reflect these changes.
23/09/2021: The following changes have been made:
1. The interventions have been updated.
2. The secondary outcome measures have been updated.
3. The plain English summary has been updated to reflect the changes above.
24/08/2021: The following changes were made to the trial record:
1. The inclusion criteria were changed.
2. The exclusion criteria were changed.
27/07/2021: The inclusion and exclusion criteria were updated.
02/02/2021: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2022 to 30/11/2022.
2. The recruitment end date was changed from 28/02/2021 to 31/07/2022.
13/07/2020: Trial’s existence confirmed by NHS Hampshire B ethics committee.
