Ireland
--:--IST
Recruiting Not applicable

Training for Men Undergoing Androgen Deprivation Therapy.

NCT06449664 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2024-05-01
Last updated
2024-06-10

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

ADT-train

ADT-train: A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy

Study summary

The goal of this clinical trial is to evaluate the effects of a newly developed training concept on men with prostate cancer undergoing androgen deprivation therapy (ADT).

The main questions it aims to answer are:

* How feasible and safe is the new training concept?
* How efficient is the training concept to counteract side effects caused by ADT?

Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects.

Participants in the intervention group will perform the new training concept twice weekly for 12 weeks. Participants in the control group will only receive usual care. All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes.

Eligibility

Sex
MALE
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. signed informed consent 2. histologically confirmed localised or locally advanced prostate cancer 3. planned radiotherapy in combination with ADT for at least six months (unfavorable intermediate risk and high-risk prostate cancer) with curative intent and with no known metastasis. Exclusion Criteria: 1. very high risk localised prostate cancer planned for radiotherapy and ADT plus abiraterone and cortisone 2. localized prostate cancer planned for radiotherapy without ADT 3. on-going or previously treated with ADT or other hormonal treatments 4. have any contraindications to physical testing/exercise as per the ACSM guidelines 5. unable to comply with study procedures

Primary outcome measure(s)

  • Aerobic fitness — Baseline and after 6 and 12 weeks
    VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer
  • Maximal leg strength — Baseline and after 6 and 12 weeks
    Isometric squat test (N) measured on force plates

Trial sites (1)

FacilityCityRegionStatus
Swedish School of Sport and Health Sciences Stockholm Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06449664 on ClinicalTrials.gov ↗ ← All trials in Sweden