NCT01669460

Brief Summary

The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below 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

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

August 16, 2012

Last Update Submit

December 18, 2013

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

  • Reduction in overall fatigue as measured by Bruera global fatigue severity scale.

    Within 4 days after completion of intervention (28 days of Red Bull™)

Secondary Outcomes (1)

  • Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)

    Within 4 days after completion of intervention (28 days of Red Bull™)

Study Arms (1)

Red Bull™ Sugar-Free Drink

EXPERIMENTAL

Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days

Other: Red Bull™ Sugar-Free Drink

Interventions

Red Bull™ Sugar-Free DrinkOTHER

Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days

Red Bull™ Sugar-Free Drink

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed prostate cancer
  • Currently receiving LHRH-agonist therapy for greater than 6 months
  • Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale
  • Able to swallow Red Bull™ Sugar-Free Drink
  • Life expectancy of at least 1 year
  • Able to read and write in English
  • Willing to limit consumption of alcohol to one drink per day

You may not qualify if:

  • Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)
  • Myocardial infarction within past 6 months
  • Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders
  • Evidence of drug or alcohol abuse
  • Known hypersensitivity to caffeine
  • Known history of liver and kidney insufficiencies
  • Known contraindications to Red Bull™ use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 1C1, Canada

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Fleshner, MD, FRCSC, MPH

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 21, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Last Updated

December 19, 2013

Record last verified: 2013-12

Locations

CA(1)