Breast activity and healthy eating after diagnosis - 2 During chemotherapy for early breast cancer
| ISRCTN | ISRCTN04156504 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04156504 |
| Secondary identifying numbers | 13255 |
- Submission date
- 19/11/2012
- Registration date
- 19/11/2012
- Last edited
- 28/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Mary Pegington
Scientific
Scientific
Wythenshawe Hospital
Genesis Prevention Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
| mary.pegington@manchester.ac.uk |
Study information
| Study design | Randomized interventional and observational trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Breast activity and healthy eating after diagnosis - 2 During chemotherapy for early breast cancer |
| Study acronym | B-AHEAD 2 |
| Study objectives | Excess weight at the time of breast cancer diagnosis and weight gain during adjuvant chemotherapy increases the risk of breast cancer recurrence and death. We and others have demonstrated that continuous energy restriction (CER) and exercise is only partially effective at limiting the 2.5-3kg weight gain which occurs during chemotherapy, and for promoting weight loss for overweight women. Our other studies in non cancer patients have shown intermittent energy restriction (IER) is equivalent or superior to continuous restriction for weight control, and our pilot studies indicate that IER could be useful amongst chemotherapy patients because the days after chemotherapy administration can be avoided. The purpose of this study is to formally assess the feasibility and effectiveness of IER to prevent chemotherapy induced weight gain and promote weight loss for overweight women compared with continuous energy restriction in a randomised trial (n=170). This study will re test whether continuous energy restriction can be effective, and whether the novel IER is better. The trial aims to identify a much needed regimen for weight control and toxicity reduction for breast cancer patients receiving chemotherapy. If either of our test regimes are succesful, this would then be tested in a larger phase III trial to evaluate its effects on relapse free and overall survival. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13255 |
| Ethics approval(s) | NRES Committee North West - Greater Manchester West, 04 April 2012, ref: 12/NW/0230 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast |
| Intervention | Comparison group (n = 85) Continuous energy restricted Mediterranean diet plus an exercise intervention (2.5 hours/ moderate activity week) Intervention group (n = 85) 2 consecutive days / week of energy restriction with an intermittent low energy diet (<50g carbohydrate / day and ad lib protein diet [self limits to approximately 800-1000 kcal/day]), and a Mediterranean diet for 5 days/week, plus an exercise intervention (2.5 hours/ moderate activity week). |
| Intervention type | Other |
| Primary outcome measure | Weight, body fat (DXA, impedence), waist and hips measured twice at baseline and post chemotherapy appointments |
| Secondary outcome measures | 1. Blood markers of chemotherapy associated toxicity measured twice at the first and final chemotherapy cycles 2. Examining the effects of the restricted and normal intake phases measured once at the final chemotherapy cycles 2. Quality of life and fatigue (functional assessment of cancer therapy; FACT-B, FACT-ES and FACT-F; measured twice at baseline and post chemotherapy appointments; 3. Serum markers of breast cancer risk prognosis measured twice at baseline and post chemotherapy appointments 4. Serum markers of cardiovascular disease measured twice at baseline and post chemotherapy appointments 5. Fitness measured twice at baseline and post chemotherapy appointments 6. Blood markers of oxidative stress measured twice at baseline and post chemotherapy appointments 7. Motivational, stage of behaviour change, health beliefs, and self-efficacy scales measured twice at baseline and post chemotherapy appointments 8. Dietary intake (7 day food diary), accelerometer and physical activity questionnaire measured at three times at baseline, post chemotherapy appointments, and half way through chemotherapy 9. Differences in self reported chemotherapy toxicity measured at each chemotherapy cycle |
| Overall study start date | 26/11/2012 |
| Completion date | 20/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 170 |
| Total final enrolment | 172 |
| Key inclusion criteria | 1. Scheduled to have standard adjuvant or neoadjuvant chemotherapy 2. Breast cancer stage I to III 3. Any age >18 years: weight affects prognosis amongst preand post menopausal women 4. BMI>19 Kg / m2 (Using IER and exercise we aim to avoid weight gain in all patients; this may lead to some weight loss in normal weight individuals). 5. Ability to understand written instructions and have completed baseline 7 day diet and exercise diaries. 6. Resident within Greater Manchester or Cheshire area only in order to maximise uptake and retention to interventions and study. 7. Written informed consent |
| Key exclusion criteria | 1. Metastatic disease 2. Previouly had chemotherapy for breast or any cancer within the last 2 years. 3. Physical/or psychiatric conditions which may impair compliance to the diet or physical activity interventions assessed from medical history by recruitment nurse/ clinician i.e. Serious digestive and/or absorptive problems, including inflammatory bowel disease. Cardiovascular, respiratory (determined from recent preoperative ECG, chest Xray, and verified from baseline fitness assessment by the trial exercise specialist (DM) Musculoskeletal disease or joint problems. Psychiatric disorders or conditions, e.g. untreated major depression, psychosis, substance abuse, severe personality disorder. 4. Medications affecting weight e.g. metformin or continuous daily steroids (23 days with chemotherapy allowed) 5. Insulin requiring diabetes, as diet and physical activity changes would require close coordination with the diabetiologist. Non-insulin requiring diabetics are eligible for the study. 6. Already commenced chemotherapy. 7. Scheduled to have weekly paclitaxel |
| Date of first enrolment | 26/11/2012 |
| Date of final enrolment | 26/03/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
University Hospital of South Manchester (UK)
Hospital/treatment centre
Hospital/treatment centre
Genesis Prevention Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
England
United Kingdom
| Website | http://www.uhsm.nhs.uk |
|---|---|
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Charity
Breast Cancer Research Trust (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- BCRT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 2016 results presented at Obesity, Physical Activity & Cancer: Life course influences and mechanisms 2016 https://www.wcrf.org/int/news-events/conferences/presentations-conferences/obesity-physical-activity-cancer-life-course. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | 15/12/2021 | 17/12/2021 | Yes | No | |
| Protocol file | version 9 | 04/08/2017 | 28/02/2023 | No | No |
Additional files
Editorial Notes
28/02/2023: The following changes were made to the trial record:
1. Protocol uploaded (not peer reviewed).
2. The overall trial end date was changed from 26/03/2014 to 20/11/2017.
17/12/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
04/09/2020: Cancer Research UK lay results summary link added to Results (plain English).
16/09/2019: The publication and dissemination plan was updated.
17/07/2018: An intention to publish date has been added.
03/07/2018: No publications found, verifying study status with principal investigator
19/05/2016: Internal review
