Androgen Deprivation Therapy Muscle Protein Metabolism and Blood Glucose

  • STATUS
    Recruiting
  • End date
    Aug 22, 2022
  • participants needed
    40
  • sponsor
    Norwegian School of Sport Sciences
Updated on 22 January 2021
insulin
androgens
antiandrogen therapy
androgen suppression
zoladex

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).

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 treatment. Commonly reported side effects are loss of lean body mass (LBM) and increased fat mass, as well as impaired glucose- and fat metabolism. Strength training has shown positive effects on LBM in PCa patients on ADT, however, counteracting a substantial LBM loss observed in the control groups seem to account for the intervention effect seen in several of the individual studies. Thus, the real LBM gain following strength training in PCa patients on ADT may be hampered compared to healthy elderly men, but data on this is limited in the literature.

The planned acute recovery study is a continuation of the physical exercise and prostate cancer (PEPC) trial, which was a randomized controlled trial investigating the effects of strength training on body composition, muscle strength, and muscle cellular outcomes during ADT.

Beyond locomotion and activity of daily living, the skeletal muscle tissue plays an important role in glucose metabolism, and impaired glucose uptake to the muscle is associated with diseases such as diabetes mellitus and cardiovascular diseases. In fact, increased levels of fasted blood glucose and insulin have been reported during the first year of ADT. Interestingly, insulin resistance has been noted as early as three months into the treatment. Insulin resistance may, in addition to the increased risk for metabolic comorbidities, also impair the anabolic response in muscles to feeding and exercise. Consequently, the accelerated muscle mass loss, and the potential limited response to strength training might be interlinked to the reduction in insulin sensitivity in PCa patients receiving ADT.

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. The present study is designed to address these issues.

PCa patients on ADT (Zoladex), along with non-ADT treated PCa patients serving as controls, will be invited to participate in this study. The aim is to investigate the influence of ADT on the basal muscle protein turnover, as well as the responses to strength training. Furthermore, secondary aims are to investigate between-group differences in blood glucose and insulin responses following a meal).

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Androgen Deprivation Therapy, Resistance Exercise, Prostate Cancer, prostate carcinoma, prostate cancers, antiandrogen therapy
Treatment Zoladex
Clinical Study IdentifierNCT03440879
SponsorNorwegian School of Sport Sciences
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Are you male?
Do you have any of these conditions: Resistance Exercise or Androgen Deprivation Therapy or Malignant neoplasm of prostate?
Do you have any of these conditions: Prostatic disorder or Prostate Disorders or prostate carcinoma or prostate cancers or Malignant neoplasm of prostate or Prostate Cancer or antiandroge...?
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 doctors (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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note