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

Sponsor

National Cancer Centre, Singapore (Other)

Overall Status

Terminated

CT.gov ID

NCT00486213

Collaborator

(none)

210

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatologic Complications Palmar-plantar Erythrodysesthesia Unspecified Adult Solid Tumor, Protocol Specific	Dietary Supplement: pyridoxine hydrochloride Other: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pyridoxine hydrochloride Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle	Dietary Supplement: pyridoxine hydrochloride Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
Placebo Comparator: Placebo Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle	Other: Placebo

Arm

Intervention/Treatment

Active Comparator: Pyridoxine hydrochloride

Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle

Dietary Supplement: pyridoxine hydrochloride

Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle

Placebo Comparator: Placebo

Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle

Other: Placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of cancer
Must be receiving single-agent capecitabine either in the adjuvant/neoadjuvant or palliative setting at a dose of ≥ 1000 mg/m² twice daily on days 1-14 (given in 3-week courses)

PATIENT CHARACTERISTICS:

Life expectancy > 12 weeks
No preexisting neuropathy
No known allergy to pyridoxine hydrochloride and its incipients
No other dermatologic condition that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior capecitabine
Concurrent radiotherapy, steroids, and/or biological therapy (e.g., trastuzumab [Herceptin®] or bevacizumab) allowed provided they do not cause hand-foot syndrome (HFS)
No other concurrent drugs (e.g., docetaxel or doxorubicin hydrochloride liposome) that can cause HFS
No concurrent drugs (e.g., oxaliplatin or taxanes) that can cause neuropathy
No concurrent pyridoxine hydrochloride-containing preparations (e.g., multivitamins or vitamin B complex)
No concurrent over-the-counter products that contain urea or lactic acid
No concurrent drugs reported to have drug interactions with pyridoxine hydrochloride (e.g., cycloserine; hydralazine; immunosuppressants; isoniazid; levodopa; estrogen or estrogen-containing contraceptives; penicillamine; phenobarbitone; phenytoin; or pyrazinamide)