Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer
RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer.
PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.
Chemotherapeutic Agent Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: pyridoxine hydrochloride
Procedure: complementary or alternative medicine procedure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)|
- First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0 [ Time Frame: up to 8 cycles ] [ Designated as safety issue: No ]
- Time to the onset of HFS ≥ grade 2 [ Time Frame: days to weeks ] [ Designated as safety issue: No ]
- Quality of life as measured by EuroQOL (EQ-5D) questionnaire [ Time Frame: QOL assessment at baseline, at beginning of cycles 2, 4, 6, 8 and at the end of the study. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Pyridoxine||Dietary Supplement: pyridoxine hydrochloride Drug: capecitabine Procedure: complementary or alternative medicine procedure|
- Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia (hand-foot syndrome [HFS]) ≥ grade 2 in patients with cancer treated with pyridoxine hydrochloride vs placebo.
- Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens.
- Compare the quality of life changes in patients treated with these regimens.
- Identify factors predicting toxicity from capecitabine chemotherapy.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and treatment setting (adjuvant/neoadjuvant vs palliative setting). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning concurrently with planned capecitabine treatment, patients receive oral pyridoxine hydrochloride once daily on days 1-21.
- Arm II: Beginning concurrently with planned capecitabine treatment, patients receive oral placebo once daily on days 1-21.
In both arms, treatment repeats every 21 days for up to 8 courses (until discontinuation of capecitabine treatment).
Quality of life is assessed at baseline, at the beginning of courses 2, 4, 6, and 8, and at the end of the study.
|National Cancer Centre - Singapore||Recruiting|
|Singapore, Singapore, 169610|
|Contact: Yoon-Sim Yap, FRACP, MBBS 65-6-436-8000|
|Principal Investigator:||Yoon-Sim Yap, FRACP, MBBS||National Cancer Centre, Singapore|