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Guaraná for Radiation Related Fatigue in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00615316
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : February 14, 2008
Sponsor:
Information provided by:
Faculdade de Medicina do ABC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fatigue Drug: Guaraná Drug: Placebo Phase 2

Detailed Description:

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 180cGy.

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 http://www.mdanderson.org/topics/fatigue/) 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 (www.ncss.com). 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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Guaraná ("Paullinia Cupana") for Radiation Related Fatigue in Breast Cancer Patients: Results Of A Pilot Double Blind Randomized Study
Study Start Date : December 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: A Drug: Guaraná
Guaraná extract 75mg/day
Other Name: Paullinia Cupana

Placebo Comparator: B Drug: Placebo
Placebo 1tab/d




Primary Outcome Measures :
  1. Fatigue [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Depression [ Time Frame: 5 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615316


Locations
Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil, 09060-650
Sponsors and Collaborators
Faculdade de Medicina do ABC
Investigators
Principal Investigator: Auro Del Giglio, MD, PhD ABC Foundation School of Medicine

Responsible Party: Auro Del Giglio, MD, Chairman of Oncology and Hematology, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT00615316     History of Changes
Other Study ID Numbers: 365/2006
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: February 14, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms