Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome. PURPOSE: This phase III randomized trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving capecitabine for advanced colorectal cancer or breast cancer.

Detailed Description
-----------------
OBJECTIVES: Primary Determine whether pyridoxine can reduce the incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity. Secondary Determine the incidence of hand-foot syndrome (HFS). Determine the overall toxicity. Determine the quality of life. Determine the response to chemotherapy. Determine the progression-free survival. Determine the level of biomarkers which might predict the occurrence of HFS. OUTLINE: This is a multicenter study. Patients are stratified according to disease (breast cancer vs colorectal cancer). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral pyridoxine hydrochloride 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy. Arm II: Patients receive oral placebo 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Evidence of hand-foot syndrome is assessed at baseline and before each course of capecitabine. Quality of life is assessed at baseline and then every 6 weeks. After completion of study treatment, patients are followed at 6 and 12 weeks.

Official Title
-----------------
A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome

Conditions
-----------------
Breast Cancer, Colorectal Cancer, Palmar-plantar Erythrodysesthesia

Intervention / Treatment
-----------------
* Dietary Supplement: pyridoxine hydrochloride
* Other: placebo
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of advanced colorectal or breast carcinoma Hormone receptor status not specified Receiving single-agent capecitabine chemotherapy Measurable disease for response assessment, determined on an individual patient basis, using conventional clinical and/or radiological methods PATIENT CHARACTERISTICS: ECOG performance status 0-2 Menopausal status not specified Life expectancy ≥ 12 weeks Hemoglobin ≥ 10 g/dL Platelet count ≥ 100,000 mm^3 WBC ≥ 3,000/mm^3 ANC ≥ 1,500/mm^3 Bilirubin ≤ 1.3 x upper limit of normal (ULN) Alkaline phosphatase ≤ 5 x ULN AST and ALT ≤ 5 x ULN Creatinine ≤ 1.5 x ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial No medical or psychiatric condition which would influence the ability to provide informed consent PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 6 weeks since prior investigational agents Concurrent radiotherapy allowed No other concurrent chemotherapy or immunotherapy No concurrent nonsteroidal anti-inflammatory drugs NSAIDs) for the primary purpose of treating hand-foot syndrome (HFS) or cancer NSAIDs for conditions other than HFS or cancer allowed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: pyridoxine hydrochloride|nan|
|Other: placebo|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hand-foot syndrome (HFS) |  |  | 
| Overall toxicity |  |  | 
| Quality of life |  |  | 
| Response to chemotherapy |  |  | 
| Progression-free survival |  |  | 
| Measurement of biomarkers that might predict the occurrence of HFS |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
palmar-plantar erythrodysesthesia, breast cancer, male breast cancer, colon cancer, rectal cancer