Status:
TERMINATED
Androgen Deprivation Therapy Muscle Protein Metabolism and Blood Glucose
Lead Sponsor:
Norwegian School of Sport Sciences
Collaborating Sponsors:
University Hospital, Akershus
Oslo University Hospital
Conditions:
Prostate Cancer
Resistance Exercise
Eligibility:
MALE
18-75 years
Phase:
NA
Brief Summary
Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), experience troublesome side effects during and after treatment (e.g., loss of lean body mass (LBM) and incr...
Detailed Description
Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), which leads to castrate levels of testosterone, experience troublesome side effects during and after treatm...
Eligibility Criteria
Inclusion
- Inclusion criteria
- All of the following conditions must apply to the prospective patient at screening prior to participation:
- Histologically verified prostate cancer, and either currently on Zoladex or without any current or no past usage of any ADT
- Between 18 and 75 years of age
- Capable of reading and understanding Norwegian, and able to provide informed consent
- Treating oncologist/ study medical doctor´s (KMR) approval for participation
- Signed informed consent must be obtained and documented according to Good Clinical Practice (GCP), and national/local regulations.
- Exclusion Criteria:
- Patients will be excluded from the study if they meet any of the following criteria:
- Routine resistance training (\>1 weekly session, last six months)
- Treated with Warfarin, or if seponation of acetylsalicylic acid is not recommended
- Conditions where heavy resistance exercise is contraindicated:
- Unregulated hypertension
- Unstable angina pectoris
- Recent myocardial infarction (\<1 year)
- Cardiac arrhythmia
- Chronic obstructive pulmonary disease
- Severe asthma
- Recent stroke (\<1 year)
- Epilepsy
- Insulin-dependent diabetes mellitus
- Unstable bone lesions with increased risk of fractures
- Conditions where patients ability to complete the training sessions is challenged:
- Uncontrolled pain
- Severe arthritis
- Scheduled hip or knee replacement
- Pathologic fractures last six months
- Amputations
- Walker or wheelchair user
- Mentally incompetent conditions:
- Severe anxiety or depression
- Dementia
- Known alcoholism or substance abuse
- Mentally retarded
Exclusion
Key Trial Info
Start Date :
September 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03440879
Start Date
September 21 2018
End Date
March 2 2023
Last Update
March 27 2023
Active Locations (1)
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1
Norwegian School of Sport Sciences
Oslo, Norway, 0806