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
EudraCT/CTIS number	2004-000325-29
ClinicalTrials.gov number	NCT00559858
Secondary identifying numbers	N/A

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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-to-see-if-pyridoxine-can-help-relieve-hand-foot-syndrome-caused-by-capecitabine

Contact information

Dr Pippa Corrie
Scientific

Oncology Centre
Box 193
Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 274376
Email	pippa.corrie@addenbrookes.nhs.uk

Study information

Study design	Interventional, randomised, placebo-controlled
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
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	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/06/2004
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	Both
Target number of participants	270, 135 in the control group
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

England
United Kingdom

Study participating centre

Oncology Centre

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Addenbrookes Hospital
Trust Research and Development Department
Box 146
Hills road
Cambridge
CB2 2QQ
England
United Kingdom

"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Industry

Roche Pharmaceuticals

No information available

Addenbrookes Oncology Centre R&D Fund

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/08/2012	31/01/2019	Yes	No

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)