A randomised placebo-controlled study evaluating the role of pyridoxine in controlling capecitabine-induced hand-foot syndrome
| ISRCTN | ISRCTN82842634 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82842634 |
| ClinicalTrials.gov (NCT) | NCT00559858 |
| Clinical Trials Information System (CTIS) | 2004-000325-29 |
| Protocol serial number | N/A |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Funders | Roche Pharmaceuticals, Addenbrookes Oncology Centre R&D Fund |
- Submission date
- 14/12/2005
- Registration date
- 06/02/2006
- Last edited
- 19/03/2020
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Pippa Corrie
Scientific
Scientific
Oncology Centre
Box 193
Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 274376 |
|---|---|
| pippa.corrie@addenbrookes.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, randomised, placebo-controlled |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised placebo-controlled study evaluating the role of pyridoxine in controlling capecitabine-induced hand-foot syndrome |
| Study acronym | CAPP-IT |
| Study objectives | Can pyridoxine reduce the need to modify the administration (by delaying or reducing the dose) of capecitabine chemotherapy? |
| Ethics approval(s) | Leicestershire, Northampton and Rutland Research Ethics Committee 2, reference number 04/Q2502/24, approved 10 June 2004 |
| Health condition(s) or problem(s) studied | Hand-foot syndrome in patients with advanced colorectal or breast cancer |
| Intervention | 1. Double-blind randomised controlled trial of pyridoxine versus placebo 2. Sweat test 3. Additional 20 ml bloods 4. Urine (20 ml) at up to three clinic visits 5. Quality of life questionnaire 6. Hand-Foot Syndrome (HFS) assessment form |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pyridoxine |
| Primary outcome measure(s) |
To determine whether pyridoxine can reduce the need for chemotherapy dose modifications (dose delay and dose reductions). |
| Key secondary outcome measure(s) |
1. Incidence of capecitabine-induced HFS |
| Completion date | 31/05/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 270 |
| Key inclusion criteria | 1. Patients with advanced colorectal or breast carcinoma receiving single agent capecitabine chemotherapy 2. No other concomitant chemotherapy or immunotherapy 3. Life expectancy more than 12 weeks 4. Performance status zero, one or two (Eastern Cooperative Oncology Group [ECOG] performance scale) 5. Aged over 18 years 6. Laboratory parameters: a. Haemoglobin B more than 10 g/dl b. Platelets more than 100,000 mm^3 c. White Cell Count (WCC) more than 3.0 x 10^9/l d. Absolute Neutrophil Count (ANC) more than 1.5 x 10^9/l e. Bilirubin less than 1.3 times Upper Limit of Normal (ULN) f. Alkaline phosphatase less than five times ULN g. Transaminases less than five times ULN h. Creatinine less than 1.5 times ULN 7. Written informed consent provided by the patient 8. Radiotherapy during the study period is allowed 9. Women of child-bearing potential must have a negative pregnancy test prior to study entry and be using adequate contraception, which must be continued for three months after the study |
| Key exclusion criteria | 1. Any concomintant chemotherapy or immunotherapy 2. Any previous investigational agent within the last six weeks 3. Any other serious or uncontrolled illness, which in the opinion of the investigator, makes it undesirable for the patient to enter the trial 4. Any medical or psychiatric condition which would influence the ability to provide informed consent |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oncology Centre
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | 31/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
19/03/2020: EudraCT number added.
31/01/2019: Publication reference added
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
