A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer.

This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who have been receiving oral Xeloda for at least 5 days will be randomized to receive prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The anticipated time on study treatment is until disease progression or development of hand-foot syndrome, and the target sample size is 500+ individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

598

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • BA
      • Salvador, BA, Brazil, 41810-570
      • Salvador, Bahia, BA, Brazil, 40170-380
    • CE
      • Fortaleza, CE, Brazil, 60336-550
    • DF
      • Taguatinga, DF, Brazil, 72115-700
    • GO
      • Goiania, GO, Brazil, 74605-020
      • Goiania, GO, Brazil, 74605-070
    • MG
      • Belo Horizonte, MG, Brazil, 30150-320
      • Belo Horizonte, MG, Brazil, 31190-131
    • PI
      • Teresina, PI, Brazil, 90430-001
    • RJ
      • Niteroi, RJ, Brazil, 24033-900
      • Rio De Janeiro, RJ, Brazil, 21020130
      • Rio de Janeiro, RJ, Brazil, 22745-130
    • RN
      • Natal, RN, Brazil, 59040150
    • RS
      • Caxias do Sul, RS, Brazil, 95020-170
      • Caxias do Sul, RS, Brazil, 95070-560
      • Ijui, RS, Brazil, 98700-000
      • Lajeado, RS, Brazil, 95900-000
      • Porto Alegre, RS, Brazil, 90035-003
      • Porto Alegre, RS, Brazil, 90610-000
      • Porto Alegre, RS, Brazil, 90020-090
      • Porto Alegre, RS, Brazil, 90430-001
    • SC
      • Itajai, SC, Brazil, 88301-220
    • SP
      • Barretos, SP, Brazil, 14784-400
      • Campinas, SP, Brazil, 13083-888
      • Jau, SP, Brazil, 17210-080
      • Ribeirao Preto, SP, Brazil, 14048-900
      • Santo Andre, SP, Brazil, 09060-650
      • Santos, SP, Brazil, 11075-350
      • Santos, SP, Brazil, 11075-900
      • Sao Jose do Rio Preto, SP, Brazil, 15090-000
      • Sao Paulo, SP, Brazil, 22793-080
      • Sao Paulo, SP, Brazil, 04026-000
      • Sao Paulo, SP, Brazil, 01221-020
      • Sao Paulo, SP, Brazil, 04039-901
      • Sorocaba, SP, Brazil, 18030-005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • breast cancer or colorectal cancer patients;
  • treated with oral Xeloda for <=5 days;
  • lack of hand-foot syndrome (palmar-plantar erythrodysesthesia).

Exclusion Criteria:

  • existence of clinical symptoms suggesting hand-foot syndrome;
  • use of doxorubicin, 5-FU and/or cytarabine for last 3 months;
  • diabetes mellitus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: Corticosteroids
As prescribed
Drug: capecitabine [Xeloda]
As prescribed
EXPERIMENTAL: 1
Drug: capecitabine [Xeloda]
As prescribed
Drug: dexpantenol [Bepantol]
As prescribed
PLACEBO_COMPARATOR: 3
Drug: capecitabine [Xeloda]
As prescribed
Drug: Placebo
As prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hand-foot syndrome onset
Time Frame: Event driven
Event driven
QoL C-30 score
Time Frame: Weeks 7, 13 and 17
Weeks 7, 13 and 17

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (ESTIMATE)

April 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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