Back to results

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

Primary Purpose

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

Status

Terminated

Phase

Phase 3

Locations

Singapore

Study Type

Interventional

Intervention

pyridoxine hydrochloride

Placebo

About this trial

This is an interventional prevention trial for Dermatologic Complications focused on measuring dermatologic complications, chemotherapeutic agent toxicity, palmar-plantar erythrodysesthesia, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

National Cancer Centre - Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pyridoxine hydrochloride

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to the onset of HFS ≥ grade 2

Quality of life as measured by EuroQOL (EQ-5D) questionnaire

Full Information

NCT ID

NCT00486213

First Posted

June 13, 2007

Last Updated

September 22, 2015

Sponsor

National Cancer Centre, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT00486213

Brief Title

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

Official Title

Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual

Study Start Date

June 2007 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Centre, Singapore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pyridoxine hydrochloride

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

pyridoxine hydrochloride

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

up to 8 cycles

Secondary Outcome Measure Information:

Title

Time to the onset of HFS ≥ grade 2

Time Frame

days to weeks

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoon-Sim Yap, FRACP, MBBS

Organizational Affiliation

National Cancer Centre, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Centre - Singapore

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

12. IPD Sharing Statement

Citations:

PubMed Identifier

28715540

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs