Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer

Phase 3

Terminated

• Conditions: Dermatologic Complications; Palmar-plantar Erythrodysesthesia; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Other: Placebo; Dietary Supplement: pyridoxine hydrochloride

• Registration Number: NCT00486213
• Lead Sponsor: National Cancer Centre, Singapore

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-13
• Study First Submitted QC: 2007-06-13
• Study First Posted: 2007-06-14
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
Pyridoxine hydrochloride	pyridoxine hydrochloride	Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle

Primary Outcome Measures

Name	Time	Method
First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0	up to 8 cycles

Secondary Outcome Measures

Name	Time	Method
Time to the onset of HFS ≥ grade 2	days to weeks
Quality of life as measured by EuroQOL (EQ-5D) questionnaire	QOL assessment at baseline, at beginning of cycles 2, 4, 6, 8 and at the end of the study.

Trial Locations

Locations (1)

National Cancer Centre - Singapore; 🇸🇬 Singapore, Singapore