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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00661102
First received: April 16, 2008
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: capecitabine [Xeloda]
Drug: dexpantenol [Bepantol]
Drug: Corticosteroids
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Hand-foot syndrome onset [ Time Frame: Event driven ] [ Designated as safety issue: Yes ]
  • QoL C-30 score [ Time Frame: Weeks 7, 13 and 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 598
Study Start Date: December 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
As prescribed
Drug: dexpantenol [Bepantol]
As prescribed
Active Comparator: 2 Drug: capecitabine [Xeloda]
As prescribed
Drug: Corticosteroids
As prescribed
Placebo Comparator: 3 Drug: capecitabine [Xeloda]
As prescribed
Drug: Placebo
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661102

Locations
Brazil
Salvador, BA, Brazil, 41810-570
Salvador, BA, Brazil, 40170-110
Fortaleza, CE, Brazil, 60336-550
Taguatinga, DF, Brazil, 72115-700
Goiania, GO, Brazil, 74605-020
Goiania, GO, Brazil, 74605-070
Belo Horizonte, MG, Brazil, 30150-221
Belo Horizonte, MG, Brazil, 31190-131
Teresina, PI, Brazil, 90430-001
Niteroi, RJ, Brazil, 24033-900
Rio De Janeiro, RJ, Brazil, 21020130
Rio de Janeiro, RJ, Brazil, 22745-130
Natal, RN, Brazil, 59040150
Caxias do Sul, RS, Brazil, 95070-560
Caxias do Sul, RS, Brazil, 95020-170
Ijui, RS, Brazil, 98700-000
Lajeado, RS, Brazil, 95900-000
Porto Alegre, RS, Brazil, 90035-903
Porto Alegre, RS, Brazil, 90610-000
Porto Alegre, RS, Brazil, 90035-003
Porto Alegre, RS, Brazil, 90430-001
Itajai, SC, Brazil, 88301-220
Barretos, SP, Brazil, 14784-400
Campinas, SP, Brazil, 13083-888
Jau, SP, Brazil, 17210-120
Ribeirao Preto, SP, Brazil, 14048-900
Santo Andre, SP, Brazil, 09060-650
Santos, SP, Brazil, 11075-900
Santos, SP, Brazil, 11075-350
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Sao Paulo, SP, Brazil, 01221-020
Sao Paulo, SP, Brazil, 04026-000
SAo Paulo, SP, Brazil, 04039-901
Sao Paulo, SP, Brazil, 04023-900
Sorocaba, SP, Brazil, 18030-005
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00661102     History of Changes
Other Study ID Numbers: ML21419
Study First Received: April 16, 2008
Last Updated: May 23, 2013
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013