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

NCT ID: NCT00486213

Last Updated: 2015-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2014-08-31

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.

Conditions

Dermatologic Complications; Palmar-plantar Erythrodysesthesia; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Pyridoxine hydrochloride

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

Group Type: ACTIVE_COMPARATOR

pyridoxine hydrochloride

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

pyridoxine hydrochloride

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoon-Sim Yap, FRACP, MBBS

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

National Cancer Centre - Singapore

Singapore, , Singapore

Countries

Singapore

References

Yap YS, Kwok LL, Syn N, Chay WY, Chia JWK, Tham CK, Wong NS, Lo SK, Dent RA, Tan S, Mok ZY, Koh KX, Toh HC, Koo WH, Loh M, Ng RCH, Choo SP, Soong RCT. Predictors of Hand-Foot Syndrome and Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1538-1545. doi: 10.1001/jamaoncol.2017.1269.

Reference Type: DERIVED

PMID: 28715540 (View on PubMed)

Other Identifiers

SINGAPORE-06-22-OTH

Identifier Type: -

Identifier Source: secondary_id

CDR0000551757

Identifier Type: -

Identifier Source: org_study_id