Androgen Deprivation Therapy Muscle Protein Metabolism and Blood Glucose

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Male

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 increased fat mass). Although the negative effects of ADT on muscle mass are well documented, the cellular effects of ADT on muscle tissue are still largely unknown, and studies investigating the mechanisms are highly warranted. Furthermore, understanding the cellular mechanisms through which ADT negatively influences muscle mass and glucose metabolism is important so that appropriate measures can be taken to counteract muscle wasting and comorbidities during ADT. Thus, PCa patients on ADT (Zoladex), along with non-ADT treated PCa patients serving as controls, will be invited to participate in this study, that aims to investigate the influence of ADT on the basal muscle protein turnover, as well as the responses to strength training. Secondary aims are to investigate between-group differences in blood glucose and insulin responses following a meal).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian School of Sport Sciences
• Collaborators: King's College London; Oslo University Hospital; Rigshospitalet, Denmark; University Hospital, Akershus; University of Copenhagen
• Treatments: Androgens; Goserelin

Criteria

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