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

NCT00486213 | Terminated Phase 3 DMC

• 2 other identifiers: CDR0000551757SINGAPORE-06-22-OTH
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

dermatologic complications; chemotherapeutic agent toxicity; palmar-plantar erythrodysesthesia; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0

  up to 8 cycles

Secondary Outcomes (2)

• 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.

Study Arms (2)

Pyridoxine hydrochloride

ACTIVE COMPARATOR

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

Dietary Supplement: pyridoxine hydrochloride

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

pyridoxine hydrochloride DIETARY_SUPPLEMENT

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

Pyridoxine hydrochloride

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre - Singapore

Singapore, 169610, Singapore

Location

Related Publications (1)

• 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.

  PMID: 28715540 DERIVED

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

Pyridoxine

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yoon-Sim Yap, FRACP, MBBS

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 14, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

SG (1)