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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by National Cancer Centre, Singapore
Sponsor:
Information provided by (Responsible Party):
Yap Yoon Sim, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT00486213
First received: June 13, 2007
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Chemotherapeutic Agent Toxicity
Dermatologic Complications
Palmar-plantar Erythrodysesthesia
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: pyridoxine hydrochloride
Drug: capecitabine
Procedure: complementary or alternative medicine procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)

Resource links provided by NLM:


Further study details as provided by National Cancer Centre, Singapore:

Primary Outcome Measures:
  • First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0 [ Time Frame: up to 8 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to the onset of HFS ≥ grade 2 [ Time Frame: days to weeks ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 296
Study Start Date: June 2007
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pyridoxine Dietary Supplement: pyridoxine hydrochloride Drug: capecitabine Procedure: complementary or alternative medicine procedure

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486213

Locations
Singapore
National Cancer Centre - Singapore Recruiting
Singapore, Singapore, 169610
Contact: Yoon-Sim Yap, FRACP, MBBS    65-6-436-8000      
Sponsors and Collaborators
National Cancer Centre, Singapore
Investigators
Principal Investigator: Yoon-Sim Yap, FRACP, MBBS National Cancer Centre, Singapore
  More Information

Additional Information:
No publications provided

Responsible Party: Yap Yoon Sim, Senior Consultant, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT00486213     History of Changes
Other Study ID Numbers: CDR0000551757, SINGAPORE-06-22-OTH
Study First Received: June 13, 2007
Last Updated: May 2, 2013
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National Cancer Centre, Singapore:
dermatologic complications
chemotherapeutic agent toxicity
palmar-plantar erythrodysesthesia
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Hand-Foot Syndrome
Drug Eruptions
Dermatitis
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Pyridoxine
Vitamin B 6
Pyridoxal
Capecitabine
Fluorouracil
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 28, 2014