Study of Pyridoxine for Hand-Foot Syndrome

Hand-foot Syndrome Clinical Trial

Official title:

Double-Blind Phase III Study of Pyridoxine vs Placebo for the Prevention of Capecitabine-induced Hand-Foot Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446147
• Other study ID #: AMC-ONCGI-0403
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2007
• Last updated: January 13, 2014
• Start date: June 2004
• Est. completion date: December 2006

Study information

• Verified date: January 2014
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Although pyridoxine has been used empirically for the prevention of capecitabine associated hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled trials. The investigators therefore performed a prospective randomized double-blind study to determine whether pyridoxine 200 mg/day can prevent the development of HFS when given concurrently with capecitabine. The investigators also tested the ability of pyridoxine to treat primary occurrence of grade 2-3 HFS.

Description:

Although pyridoxine has been used empirically for the prevention of capecitabine associated HFS, its efficacy needs to be demonstrated in prospective controlled trials. We estimated that the HFS rate with placebo and pyridoxine would be 0.35 and 0.18, respectively, and we therefore calculated that a sample size of 345 patients would be necessary to detect these hazard rates with an 80% power (β=0.2) and two-sided significance level of α=0.05. We assumed a follow up loss rate of 10%, thus requiring 380 patients to be randomized. Chemotherapy-naive patients with gastrointestinal tract cancers who were scheduled for capecitabine-containing chemotherapy were assigned to receive oral pyridoxine or placebo in randomized double-blind placebo controlled study. Pyridoxine 100 mg b.i.d was prescribed to the patients in the pyridoxine group, identical placebo 100 mg b.i.d was prescribed in the placebo group by the closed envelop randomization. Patients were stratified by chemotherapy regimen: capecitabine alone (X), capecitabine and cisplatin (XP), or docetaxel, capecitabine, and cisplatin (DXP). Patients were observed until NCI CTC grade 2 or 3 HFS developed or capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade 2 or 3 HFS were randomized to receive pyridoxine or placebo for the next chemotherapy cycle to determine whether pyridoxine could improve HFS, and the same treatment was continued for 2 chemotherapy cycles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Gastrointestinal tract cancer patients treated with capecitabine-containing chemotherapy as a first-line treatment were randomly allocated to concurrent treatment with pyridoxine or placebo.

• All patients were 18 to 70 years old

• Had Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower

• An estimated life expectancy > 3 months

• Adequate bone marrow function, including white blood cell (WBC) count of >3500 cells/? and platelet count of >100000/?

• Adequate renal function (serum creatinine concentration <1.5 mg/?)

• Adequate liver function with (serum bilirubin concentration <1.5 mg/?, transaminase <3 times the upper normal limit, and serum albumin >2.5 mg/?).

Exclusion Criteria:

• Previous treatment for HFS

• Hypersensitivity to pyridoxine

• A combination of other malignancies

• Serious illnesses or medical conditions

• Immune suppression or positive human immunodeficiency virus (HIV) serology

• Pregnant or lactating women.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hand-foot Syndrome
• Syndrome

Intervention

Drug:
• Pyridoxine
100mg BID/daily, Per oral
• Placebo
placebo 100mg BID/daily, Per oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome	A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.	Up to 2 years	No
Secondary	Number of Patients With Hand-foot Syndrome	Number of patients with any grade of hand-foot syndrome	Up to 2 years	No