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

This study has been completed.
Sponsor:
Information provided by:
Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT01043913
First received: December 22, 2009
Last updated: January 6, 2010
Last verified: November 2009

December 22, 2009
January 6, 2010
February 2008
September 2009   (final data collection date for primary outcome measure)
Fatigue improvement between the baseline to D21 or from D21 to D42 measured by Chalder Fatigue Scale, FACT-F and FACT-ES questionnaires [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01043913 on ClinicalTrials.gov Archive Site
To access the quality of life between the baseline to D21 or from D21 to D42 measured by FACT-F and FACT ES questionnaires [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Guarana (Paullinia Cupana) for Breast Cancer Chemotherapy-related Fatigue
Guaraná ("Paullinia Cupana") for Chemotherapy Related Fatigue in Breast Cancer Patients: Results Of A Pilot Double Blind Randomized Study

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.

The aim of this study is evaluate the favourable effects of Guaraná in quality of life and Fatigue in patients undergoing Chemotherapy treatment for Breast Cancer. After approval by our Institutional Review Board, we included consenting patients with a histological diagnosis of Breast Cancer for whom Chemotherapy was indicated.

Patients who agreed to participate in the study were submitted initially to a screening interview with the Brief Fatigue Inventory questionnaire from MD Anderson. If the patient presented with a severe fatigue, anemia (HB<11.0), hypothyroidism or psychiatric disorders she was excluded. If she presented with a mild or moderate fatigue the follow up continued and the patient was assessed 21 days later after her first cycle of chemotherapy with the same questionnaire. If an increase in fatigue levels occurred from mild to moderate, mild to severe or moderate to severe the patient was randomly assigned to receive either Guaraná 50mg or a placebo p.o. q12 for 21 days. At this moment the patient answered a General questionnaire, FACIT-F, FACIT-ES, HADS, Pittsburgh Sleep Quality Index and Chalder Fatigue Questionnaire (Day 1).

After the second cycle of chemotherapy the patient underwent a "wash out" period of 7 days without any intervention, and after that period she received placebo or Guaraná according to the cross over design after answering for the second time the questionnaires above (Day 29) and also the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). After 21 days (Day 42) she was assessed again with the same questionnaires used in the second interview.

The patient's cancer diagnosis, treatment history, concurrent medication was recorded during the pretreatment and The Brief Fatigue Inventory was answered before each assessment.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Signs and Symptoms
  • Neoplasms
  • Neoplasms by Site
  • Fatigue
  • Breast Neoplasms
  • Breast Diseases
Drug: Guarana extract
Guarana extract 50mg q12 hours for 21 days
Other Name: Paullinia Cupana
  • Experimental: Guaraná extract 50mg q12 hours
    Guaraná extract pills of 50mg q12 hours for 21 days
    Intervention: Drug: Guarana extract
  • Placebo Comparator: Placebo 1 tab q12 hours
    Placebo pills 1 tab q12 hours for 21 days
    Intervention: Drug: Guarana extract

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological diagnosis of Breast Cancer
  • Patients undergoing Chemotherapy (First Cycle)
  • 18 years old or older

Exclusion Criteria:

  • Hypothyroidism
  • Clinical Depression
  • Prior Chemotherapy
  • Anemia
  • Unable to sign informed consent
  • Severe Fatigue
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01043913
mairapaschoin
No
Auro Del Giglio, MD, PhD, ABC Foundation School of Medicine
Faculdade de Medicina do ABC
Not Provided
Study Director: Auro D Giglio, MD, PhD Faculdade de Medicina do ABC
Principal Investigator: Maira P Oliveira Campos, MD Faculdade de Medicina do ABC
Faculdade de Medicina do ABC
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP