Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 13, 2007
May 2, 2013
June 2007
December 2014   (final data collection date for primary outcome measure)
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 ]
First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0
Complete list of historical versions of study NCT00486213 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to the onset of HFS ≥ grade 2
  • Quality of life as measured by EuroQOL (EQ-5D) questionnaire
Not Provided
Not Provided
 
Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer
Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • 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
Placebo Comparator: Pyridoxine
Interventions:
  • Dietary Supplement: pyridoxine hydrochloride
  • Drug: capecitabine
  • Procedure: complementary or alternative medicine procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
296
Not Provided
December 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Singapore
 
NCT00486213
CDR0000551757, SINGAPORE-06-22-OTH
Yes
Yap Yoon Sim, National Cancer Centre, Singapore
National Cancer Centre, Singapore
Not Provided
Principal Investigator: Yoon-Sim Yap, FRACP, MBBS National Cancer Centre, Singapore
National Cancer Centre, Singapore
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP