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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661102
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Corticosteroids Drug: Placebo Drug: capecitabine [Xeloda] Drug: dexpantenol [Bepantol] Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 598 participants
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: capecitabine [Xeloda]
As prescribed
Drug: dexpantenol [Bepantol]
As prescribed
Active Comparator: 2 Drug: Corticosteroids
As prescribed
Drug: capecitabine [Xeloda]
As prescribed
Placebo Comparator: 3 Drug: Placebo
As prescribed
Drug: capecitabine [Xeloda]
As prescribed

Primary Outcome Measures :
  1. Hand-foot syndrome onset [ Time Frame: Event driven ]
  2. QoL C-30 score [ Time Frame: Weeks 7, 13 and 17 ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661102

Salvador, Bahia, BA, Brazil, 40170-380
Salvador, BA, Brazil, 41810-570
Fortaleza, CE, Brazil, 60336-550
Taguatinga, DF, Brazil, 72115-700
Goiania, GO, Brazil, 74605-020
Goiania, GO, Brazil, 74605-070
Belo Horizonte, MG, Brazil, 30150-320
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, 95020-170
Caxias do Sul, RS, Brazil, 95070-560
Ijui, RS, Brazil, 98700-000
Lajeado, RS, Brazil, 95900-000
Porto Alegre, RS, Brazil, 90020-090
Porto Alegre, RS, Brazil, 90035-003
Porto Alegre, RS, Brazil, 90430-001
Porto Alegre, RS, Brazil, 90610-000
Itajai, SC, Brazil, 88301-220
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, 01221-020
Sao Paulo, SP, Brazil, 04026-000
Sao Paulo, SP, Brazil, 04039-901
Sao Paulo, SP, Brazil, 22793-080
Sorocaba, SP, Brazil, 18030-005
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00661102     History of Changes
Other Study ID Numbers: ML21419
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Breast Neoplasms
Hand-Foot Syndrome
Neoplasms by Site
Breast Diseases
Skin Diseases
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents