Study of Red Bull™ Sugar-Free Drink for Reduction of Fati... | NCT01669460

Studies
Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

NCT01669460

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Dec 19, 2013Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Fatigue

Interventions

Red Bull™ Sugar-Free Drink

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2013Actual

Completion Date

Not provided

First Submitted Date

Aug 16, 2012

First Submission Date that Met QC Criteria

Aug 16, 2012

First Posted Date

Aug 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2013

Last Update Posted Date

Dec 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Red Bull™ Sugar-Free Drink	Other	Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days	Red Bull™ Sugar-Free Drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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™)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil Fleshner, MD, FRCSC, MPH	University Health Network, Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network		Toronto	Ontario	M5T 1C1	Canada

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms