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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)

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 Summary:

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.


Sponsor: National Cancer Centre, Singapore

Current Primary Outcome: First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0 [ Time Frame: up to 8 cycles ]

Original Primary Outcome: First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0

Current Secondary Outcome:

  • Time to the onset of HFS ≥ grade 2 [ Time Frame: days to weeks ]
  • 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. ]


Original Secondary Outcome:

  • Time to the onset of HFS ≥ grade 2
  • Quality of life as measured by EuroQOL (EQ-5D) questionnaire


Information By: National Cancer Centre, Singapore

Dates:
Date Received: June 13, 2007
Date Started: June 2007
Date Completion:
Last Updated: September 22, 2015
Last Verified: September 2015