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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Corticosteroids

Placebo

capecitabine [Xeloda]

dexpantenol [Bepantol]

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

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

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Hand-foot syndrome onset

QoL C-30 score

Secondary Outcome Measures

Adverse events

Full Information

NCT ID

NCT00661102

First Posted

April 16, 2008

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00661102

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Enrollment

598 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Corticosteroids

Intervention Description

As prescribed

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

As prescribed

Intervention Type

Drug

Intervention Name(s)

capecitabine [Xeloda]

Intervention Description

As prescribed

Intervention Type

Drug

Intervention Name(s)

dexpantenol [Bepantol]

Intervention Description

As prescribed

Primary Outcome Measure Information:

Title

Hand-foot syndrome onset

Time Frame

Event driven

Title

QoL C-30 score

Time Frame

Weeks 7, 13 and 17

Secondary Outcome Measure Information:

Title

Adverse events

Time Frame

Throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Salvador, Bahia

State/Province

ZIP/Postal Code

40170-380

Country

Brazil

City

Salvador

State/Province

ZIP/Postal Code

41810-570

Country

Brazil

City

Fortaleza

State/Province

ZIP/Postal Code

60336-550

Country

Brazil

City

Taguatinga

State/Province

ZIP/Postal Code

72115-700

Country

Brazil

City

Goiania

State/Province

ZIP/Postal Code

74605-020

Country

Brazil

City

Goiania

State/Province

ZIP/Postal Code

74605-070

Country

Brazil

City

Belo Horizonte

State/Province

ZIP/Postal Code

30150-320

Country

Brazil

City

Belo Horizonte

State/Province

ZIP/Postal Code

31190-131

Country

Brazil

City

Teresina

State/Province

ZIP/Postal Code

90430-001

Country

Brazil

City

Niteroi

State/Province

ZIP/Postal Code

24033-900

Country

Brazil

City

Rio De Janeiro

State/Province

ZIP/Postal Code

21020130

Country

Brazil

City

Rio de Janeiro

State/Province

ZIP/Postal Code

22745-130

Country

Brazil

City

Natal

State/Province

ZIP/Postal Code

59040150

Country

Brazil

City

Caxias do Sul

State/Province

ZIP/Postal Code

95020-170

Country

Brazil

City

Caxias do Sul

State/Province

ZIP/Postal Code

95070-560

Country

Brazil

City

Ijui

State/Province

ZIP/Postal Code

98700-000

Country

Brazil

City

Lajeado

State/Province

ZIP/Postal Code

95900-000

Country

Brazil

City

Porto Alegre

State/Province

ZIP/Postal Code

90020-090

Country

Brazil

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-003

Country

Brazil

City

Porto Alegre

State/Province

ZIP/Postal Code

90430-001

Country

Brazil

City

Porto Alegre

State/Province

ZIP/Postal Code

90610-000

Country

Brazil

City

Itajai

State/Province

ZIP/Postal Code

88301-220

Country

Brazil

City

Barretos

State/Province

ZIP/Postal Code

14784-400

Country

Brazil

City

Campinas

State/Province

ZIP/Postal Code

13083-888

Country

Brazil

City

Jau

State/Province

ZIP/Postal Code

17210-080

Country

Brazil

City

Ribeirao Preto

State/Province

ZIP/Postal Code

14048-900

Country

Brazil

City

Santo Andre

State/Province

ZIP/Postal Code

09060-650

Country

Brazil

City

Santos

State/Province

ZIP/Postal Code

11075-350

Country

Brazil

City

Santos

State/Province

ZIP/Postal Code

11075-900

Country

Brazil

City

Sao Jose do Rio Preto

State/Province

ZIP/Postal Code

15090-000

Country

Brazil

City

Sao Paulo

State/Province

ZIP/Postal Code

01221-020

Country

Brazil

City

Sao Paulo

State/Province

ZIP/Postal Code

04026-000

Country

Brazil

City

Sao Paulo

State/Province

ZIP/Postal Code

04039-901

Country

Brazil

City

Sao Paulo

State/Province

ZIP/Postal Code

22793-080

Country

Brazil

City

Sorocaba

State/Province

ZIP/Postal Code

18030-005

Country

Brazil

12. IPD Sharing Statement

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

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