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
  Purpose

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.


Condition Intervention Phase
Signs and Symptoms
Neoplasms
Neoplasms by Site
Fatigue
Breast Neoplasms
Breast Diseases
Drug: Guarana extract
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Guaraná ("Paullinia Cupana") for Chemotherapy Related Fatigue in Breast Cancer Patients: Results Of A Pilot Double Blind Randomized Study

Resource links provided by NLM:


Further study details as provided by Faculdade de Medicina do ABC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guaraná extract 50mg q12 hours
Guaraná extract pills of 50mg q12 hours for 21 days
Drug: Guarana extract
Guarana extract 50mg q12 hours for 21 days
Other Name: Paullinia Cupana
Placebo Comparator: Placebo 1 tab q12 hours
Placebo pills 1 tab q12 hours for 21 days
Drug: Guarana extract
Guarana extract 50mg q12 hours for 21 days
Other Name: Paullinia Cupana

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043913

Locations
Brazil
Faculdade de Medicina do ABC
Santo Andre, SP, Brazil, 09060650
Sponsors and Collaborators
Faculdade de Medicina do ABC
Investigators
Study Director: Auro D Giglio, MD, PhD Faculdade de Medicina do ABC
Principal Investigator: Maira P Oliveira Campos, MD Faculdade de Medicina do ABC
  More Information

Publications:
Responsible Party: Auro Del Giglio, MD, PhD, ABC Foundation School of Medicine
ClinicalTrials.gov Identifier: NCT01043913     History of Changes
Other Study ID Numbers: mairapaschoin
Study First Received: December 22, 2009
Last Updated: January 6, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade de Medicina do ABC:
Fatigue
Breast Neoplasms
Quality of Life
Paullinia

Additional relevant MeSH terms:
Breast Diseases
Breast Neoplasms
Fatigue
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014