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Guarana (Paullinia Cupana) for Breast Cancer Chemotherapy-related Fatigue

NCT01043913 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-01-07

No results posted yet for this study

Summary

The investigators hypothesize that Guaraná, a native plant from the Amazon, might improve chemotherapy-induced fatigue in breast cancer patients undergoing treatment. In order to assess this, the investigators randomized patients to either guaraná extract or to placebo, switching the assigned treatment mid-term through the cycles of Chemotherapy.

Conditions

  • Signs and Symptoms
  • Neoplasms
  • Neoplasms by Site
  • Fatigue
  • Breast Neoplasms
  • Breast Diseases

Interventions

DRUG

Guarana extract

Guarana extract 50mg q12 hours for 21 days

Sponsors & Collaborators

  • Faculdade de Medicina do ABC

    lead OTHER

Principal Investigators

  • Auro D Giglio, MD, PhD · Faculdade de Medicina do ABC

  • Maira P Oliveira Campos, MD · Faculdade de Medicina do ABC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01043913 on ClinicalTrials.gov