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

National Cancer Centre, Singapore

Status and phase

Terminated

Phase 3

Conditions

Palmar-plantar Erythrodysesthesia

Unspecified Adult Solid Tumor, Protocol Specific

Dermatologic Complications

Treatments

Dietary Supplement: pyridoxine hydrochloride

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00486213

CDR0000551757

SINGAPORE-06-22-OTH

Details and patient eligibility

About

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.

Full 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.

Enrollment

210 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)