Clinical trial NCT00661102: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hand-foot syndrome onset
timeFrame: Event driven
measure: QoL C-30 score
timeFrame: Weeks 7, 13 and 17
Secondary outcomes:
measure: Adverse events
timeFrame: Throughout study
Other outcomes:
Locations:
city: Salvador, Bahia
country: Brazil
state: BA
city: Salvador
country: Brazil
state: BA
city: Fortaleza
country: Brazil
state: CE
city: Taguatinga
country: Brazil
state: DF
city: Goiania
country: Brazil
state: GO
city: Goiania
country: Brazil
state: GO
city: Belo Horizonte
country: Brazil
state: MG
city: Belo Horizonte
country: Brazil
state: MG
city: Teresina
country: Brazil
state: PI
city: Niteroi
country: Brazil
state: RJ
city: Rio De Janeiro
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Natal
country: Brazil
state: RN
city: Caxias do Sul
country: Brazil
state: RS
city: Caxias do Sul
country: Brazil
state: RS
city: Ijui
country: Brazil
state: RS
city: Lajeado
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Itajai
country: Brazil
state: SC
city: Barretos
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Jau
country: Brazil
state: SP
city: Ribeirao Preto
country: Brazil
state: SP
city: Santo Andre
country: Brazil
state: SP
city: Santos
country: Brazil
state: SP
city: Santos
country: Brazil
state: SP
city: Sao Jose do Rio Preto
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sorocaba
country: Brazil
state: SP
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: