Condition category
Cancer
Date applied
14/12/2005
Date assigned
06/02/2006
Last edited
09/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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

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 measures

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

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

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes