NCT00615316

Brief Summary

We hypothesize that Guaraná, a native plant from the Amazon, might improve radiation-induced fatigue in breast cancer patients undergoing treatment. In order to assess this, we randomized patients to either guaraná extract or to placebo, switching the assigned treatment mid-term through the radiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

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

December 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
Last Updated

February 14, 2008

Status Verified

February 1, 2008

Enrollment Period

6 months

First QC Date

February 4, 2008

Last Update Submit

February 13, 2008

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    5 weeks

Secondary Outcomes (1)

  • Depression

    5 weeks

Study Arms (2)

A

EXPERIMENTAL
Drug: Guaraná

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

GuaranáDRUG

Guaraná extract 75mg/day

Also known as: Paullinia Cupana
A
PlaceboDRUG

Placebo 1tab/d

B

Eligibility Criteria

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

You may qualify if:

  • histological diagnosis of early stage Breast Cancer
  • years old or older

You may not qualify if:

  • prior breast radiation
  • anemia
  • clinical depression
  • unable to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Auro Del Giglio, MD, PhD

    ABC Foundation School of Medicine

    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

February 4, 2008

First Posted

February 14, 2008

Study Start

December 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 14, 2008

Record last verified: 2008-02

Locations

BR(1)