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

NCT ID: NCT01043913

Last Updated: 2010-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-12-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Guaraná extract 50mg q12 hours

Guaraná extract pills of 50mg q12 hours for 21 days

Group Type: EXPERIMENTAL

Guarana extract

Intervention Type: DRUG

Guarana extract 50mg q12 hours for 21 days

Placebo 1 tab q12 hours

Placebo pills 1 tab q12 hours for 21 days

Group Type: PLACEBO_COMPARATOR

Guarana extract

Intervention Type: DRUG

Guarana extract 50mg q12 hours for 21 days

Interventions

Guarana extract

Guarana extract 50mg q12 hours for 21 days

Intervention Type: DRUG

Other Intervention Names

Paullinia Cupana

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Faculdade de Medicina do ABC

OTHER

Sponsor Role: lead

Responsible Party

ABC Foundation School of Medicine

Principal Investigators

Auro D Giglio, MD, PhD

Role: STUDY_DIRECTOR

Faculdade de Medicina do ABC

Maira P Oliveira Campos, MD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina do ABC

Locations

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Countries

Brazil

References

de Souza Fede 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. doi: 10.1097/COC.0b013e31804b40d9.

Reference Type: BACKGROUND

PMID: 17762445 (View on PubMed)

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 guarana (Paullinia cupana) for postradiation fatigue and depression: results of a pilot double-blind randomized study. J Altern Complement Med. 2009 Apr;15(4):431-3. doi: 10.1089/acm.2008.0324.

Reference Type: RESULT

PMID: 19388866 (View on PubMed)

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 guarana (Paullinia cupana). Appetite. 2008 Mar-May;50(2-3):506-13. doi: 10.1016/j.appet.2007.10.007. Epub 2007 Oct 30.

Reference Type: RESULT

PMID: 18077056 (View on PubMed)

Other Identifiers

mairapaschoin

Identifier Type: -

Identifier Source: org_study_id