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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486213
|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|