NCT01043913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
Last Updated

January 7, 2010

Status Verified

November 1, 2009

Enrollment Period

1.6 years

First QC Date

December 22, 2009

Last Update Submit

January 6, 2010

Conditions

Signs and SymptomsNeoplasmsNeoplasms by SiteFatigueBreast NeoplasmsBreast Diseases

Keywords

FatigueBreast NeoplasmsQuality of LifePaullinia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

Guaraná extract 50mg q12 hours

EXPERIMENTAL

Guaraná extract pills of 50mg q12 hours for 21 days

Drug: Guarana extract

Placebo 1 tab q12 hours

PLACEBO COMPARATOR

Placebo pills 1 tab q12 hours for 21 days

Drug: Guarana extract

Interventions

Guarana extractDRUG

Guarana extract 50mg q12 hours for 21 days

Also known as: Paullinia Cupana
Guaraná extract 50mg q12 hoursPlacebo 1 tab q12 hours

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hypothyroidism
  • Clinical Depression
  • Prior Chemotherapy
  • Anemia
  • Unable to sign informed consent
  • Severe Fatigue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060650, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 17762445BACKGROUND

  • 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.

    PMID: 19388866RESULT

  • 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.

    PMID: 18077056RESULT

MeSH Terms

Conditions

Signs and SymptomsNeoplasmsNeoplasms by SiteFatigueBreast NeoplasmsBreast Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Auro D Giglio, MD, PhD

    Faculdade de Medicina do ABC

    STUDY DIRECTOR

  • Maira P Oliveira Campos, MD

    Faculdade de Medicina do ABC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2009

First Posted

January 7, 2010

Study Start

February 1, 2008

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

January 7, 2010

Record last verified: 2009-11

Locations

BR(1)