Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Pippa Corrie
ORCID ID
Contact details
Oncology Centre
Box 193
Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 274376
pippa.corrie@addenbrookes.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00559858
Protocol/serial number
N/A
Study information
Scientific title
A randomised placebo-controlled study evaluating the role of pyridoxine in controlling capecitabine-induced hand-foot syndrome
Acronym
CAPP-IT
Study hypothesis
Can pyridoxine reduce the need to modify the administration (by delaying or reducing the dose) of capecitabine chemotherapy?
Ethics approval
Leicestershire, Northampton and Rutland Research Ethics Committee 2, reference number 04/Q2502/24, approved 10 June 2004
Study design
Interventional, randomised, placebo-controlled
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Pyridoxine
Primary outcome measure
To determine whether pyridoxine can reduce the need for chemotherapy dose modifications (dose delay and dose reductions).
Secondary outcome measures
1. Incidence of capecitabine-induced HFS
2. Overall toxicity
3. Quality of life
4. Response to chemotherapy
5. Progression-free survival
6. Measurement of biomarkers which might predict the occurrence of HFS
Overall trial start date
01/06/2004
Overall trial end date
31/05/2007
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
270, 135 in the control group
Participant 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
Recruitment start date
01/06/2004
Recruitment end date
31/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oncology Centre
Cambridge
CB2 2QQ
United Kingdom
Funders
Funder type
Industry
Funder name
Roche Pharmaceuticals
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Addenbrookes Oncology Centre R&D Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in https://doi.org/10.1038/bjc.2012.318 (added 31/01/2019)