Fatigue Clinical Trial
Official title:
Guaraná ("Paullinia Cupana") for Radiation Related Fatigue in Breast Cancer Patients: Results Of A Pilot Double Blind Randomized Study
We hypothesize that Guaraná, a native plant from the Amazon, might improve radiation-induced fatigue in breast cancer patients undergoing treatment. In order to assess this, we randomized patients to either guaraná extract or to placebo, switching the assigned treatment mid-term through the radiation.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - histological diagnosis of early stage Breast Cancer - 18 years old or older Exclusion Criteria: - prior breast radiation - anemia - clinical depression - unable to sign informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Faculdade de Medicina do ABC | Santo André | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Faculdade de Medicina do ABC |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue | 5 weeks | Yes | |
Secondary | Depression | 5 weeks | Yes |
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