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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043913
• Other study ID #: mairapaschoin
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: January 6, 2010
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: November 2009
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Guarana extract
Guarana extract 50mg q12 hours for 21 days

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo Andre	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

da Costa Miranda V, Trufelli DC, Santos J, Campos MP, Nobuo M, da Costa Miranda M, Schlinder F, Riechelmann R, del Giglio A. Effectiveness of guaraná (Paullinia cupana) for postradiation fatigue and depression: results of a pilot double-blind randomized s — View Citation

de Souza Fêde AB, Bensi CG, Trufelli DC, de Oliveira Campos MP, Pecoroni PG, Ranzatti RP, Kaliks R, Del Giglio A. Multivitamins do not improve radiation therapy-related fatigue: results of a double-blind randomized crossover trial. Am J Clin Oncol. 2007 Aug;30(4):432-6. — View Citation

Kennedy DO, Haskell CF, Robertson B, Reay J, Brewster-Maund C, Luedemann J, Maggini S, Ruf M, Zangara A, Scholey AB. Improved cognitive performance and mental fatigue following a multi-vitamin and mineral supplement with added guaraná (Paullinia cupana). — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue improvement between the baseline to D21 or from D21 to D42 measured by Chalder Fatigue Scale, FACT-F and FACT-ES questionnaires		42 days	Yes
Secondary	To access the quality of life between the baseline to D21 or from D21 to D42 measured by FACT-F and FACT ES questionnaires		42 days	Yes