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NCT01226888 · ClinicalTrials.gov registry record
Changes in Brown Adipose Tissue Activity In Men Receiving Androgen Deprivation Therapy for Prostate Cancer
A clinical trial, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- 2
- Enrollment target
NCT01226888: Clinical Trial study, sponsored by Massachusetts General Hospital.
NCT01226888 is a clinical trial that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01226888 was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
Androgen deprivation therapy (ADT) is considered standard of care for prostate cancer. However, changes in the patients metabolism are usually seen as a result of hormone therapy. These changes include increased fat mass, decreased lean mass, weight gain, high blood cholesterol, increased incidence of diabetes, and possibly increased incidence of cardiac events such as heart attack. The researchers of this trial would like to learn if these change in body mass are affected by the presence of brown fat in the body. Brown fat is made up of fat cells that are stored in the body and generate heat to control body temperature. Levels of brown fat are at the highest in newborn babies and decrease over time into adulthood. The researchers of this trial would like to learn more about these changes in metabolism during prostate cancer treatment by studying the changes in brown fat during the first 12 months of hormone therapy.
Primary Outcome
To assess the change in cold-activated borwn adipose tissue (BAT) activity upon initiation of GnRH agoinist or antagoinist therapy among men treated for prostate cancer. The primary endpoint is percent change in cold-activated BAT volumne after 12 months of treatment.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-10 |
Why NCT01226888 stopped before completion
NCT01226888 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01226888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01226888 about?
NCT01226888 is a clinical study titled "Changes in Brown Adipose Tissue Activity In Men Receiving Androgen Deprivation Therapy for Prostate Cancer". Androgen deprivation therapy (ADT) is considered standard of care for prostate cancer. However, changes in the patients metabolism are usually seen as a result of hormone therapy. These changes include increased fat mass, decreased lean mass, weight gain, high blood cholesterol, increased incidence ...
What is the current status of trial NCT01226888?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2010-09. Estimated completion is 2012-10.
Who is sponsoring clinical trial NCT01226888?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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