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Guaraná ("Paullinia Cupana") for Radiation Related Fatigue in Breast Cancer Patients: Results Of A Pilot Double Blind Randomized Study

Phase 2
18 Years
Not Enrolling

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Trial Information

Guaraná ("Paullinia Cupana") for Radiation Related Fatigue in Breast Cancer Patients: Results Of A Pilot Double Blind Randomized Study

The aim of this study is evaluate the favourable effects of Guaraná in memory and cognition
in humans After approval by our Institutional Review Board, we included consenting patients
with a histological diagnosis of early stage Breast Cancer for whom adjuvant radiation
therapy was indicated. We excluded patients with a previous history of Radiation Therapy,
anemia or clinical depression. We also excluded patients who were unable to grant informed
consent or those who had medical contraindindications for the use of Guaraná (because of its
psycho stimulant effect) such as uncontrolled hypertension, previous history of cardiac
arrhythmia and insomnia.

The radiation therapy for patients who underwent mastectomy consisted of 28 fractions of

This study had a double-blind randomized design with crossover between experimental arms.
After getting informed consent, we randomized patients at the beginning of radiation
treatments (Phase I) to either 75 mg of Guaraná extract daily (Group A) or to Placebo (Group
B). Randomization was centralized by the pharmacist. Halfway through the radiation
treatments (Phase II), we switched patients from placebo to guaraná and vice versa. The
protocol ended at the last session of radiation treatments (Phase III). In each of these
three phases a new assessment of fatigue and depressive symptoms was undertaken, ie:
immediately before the first radiation treatment (phase I); at switching (phase II) and
right before the start of the last radiation treatment (phase III). At these three
assessment points, patients had to complete the Chalder Fatigue Scale,4 the MD Anderson
Brief Fatigue Inventory (available at available
in Portuguese, and the Beck Inventory Depression Scale II also validated in Portuguese.

We conducted the statistical analysis of the data with the Numerical Control Software
Solution ( We employed the repeated measures analysis of variance (ANOVA) test
to compare tests scores within the same patient group and the ANOVA test to compare test's
scores between the two groups (at similar phases of the study).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

5 weeks

Safety Issue:


Principal Investigator

Auro Del Giglio, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

ABC Foundation School of Medicine


Brazil: National Committee of Ethics in Research

Study ID:




Start Date:

December 2006

Completion Date:

June 2007

Related Keywords:

  • Fatigue
  • Breast Neoplasms
  • Fatigue