Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer
This study is currently recruiting participants.
Verified May 2013 by National Cancer Centre, Singapore
Sponsor:
National Cancer Centre, Singapore
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
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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
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:
|
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 June 18, 2013