Menu
Recruiting NCT06449664

Training for Men Undergoing Androgen Deprivation Therapy.

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADT-train.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 50 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.

Overview

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.

Detailed description

Detailed description of the training concept applied in the intervention:

The two weekly training sessions will be separated by at least two days and supervised by appropriately trained exercise professionals at The Swedish School of Sport and Health Sciences. The training includes a 10 min warm-up followed by 3-4 sets of 8 maximal repetitions on the flywheel machine followed by 16-24, 20 s intervals on a Monark cycle ergometer. The intervals will be performed as 3 blocks with the intention to execute 8 intervals in each block. When a participant manages to perform all 3 blocks with 8 intervals in each block (a total of 24 intervals) the resistance will be increased by \~20 W. The rest period between the intervals will be set to 10 s and the rest between the blocks to 2 min. The starting workload of the intervals will be individually adjusted to \~115 % of the participant's power output at VO2peak. The total duration of a training session will be 30-40 min (including worm-up).

Interventions

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

Primary outcome measures

  • Aerobic fitness [Time frame: Baseline and after 6 and 12 weeks]
  • Maximal leg strength [Time frame: Baseline and after 6 and 12 weeks]
Secondary outcome measures (12)
  • Body fat [Time frame: Baseline and after 6 and 12 weeks]
  • Lean body mass [Time frame: Baseline and after 6 and 12 weeks]
  • Bone mineral density [Time frame: Baseline and after 6 and 12 weeks]
  • Quadriceps cross-sectional area [Time frame: Baseline and after 6 and 12 weeks]
  • Static balance [Time frame: Baseline and after 6 and 12 weeks]
  • Walk capacity [Time frame: Baseline and after 6 and 12 weeks]
  • Lower body muscular endurance [Time frame: Baseline and after 6 and 12 weeks]
  • Blood pressure [Time frame: Baseline and after 6 and 12 weeks]
  • Whole body glucose uptake [Time frame: Baseline and after 6 and 12 weeks]
  • Whole body insulin response [Time frame: Baseline and after 6 and 12 weeks]
  • Blood biomarkers related to cardiovascular disease. [Time frame: Baseline and after 6 and 12 weeks]
  • Muscle fiber cross-sectional area (CSA) [Time frame: Baseline and after 12 weeks]

Eligibility criteria

Inclusion criteria

  • signed informed consent
  • histologically confirmed localised or locally advanced prostate cancer
  • 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

  • very high risk localised prostate cancer planned for radiotherapy and ADT plus abiraterone and cortisone
  • localized prostate cancer planned for radiotherapy without ADT
  • on-going or previously treated with ADT or other hormonal treatments
  • have any contraindications to physical testing/exercise as per the ACSM guidelines
  • unable to comply with study procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Sweden · 1 center
  • Swedish School of Sport and Health Sciences — Stockholm

Identifiers

NCT: NCT06449664 · 2024-00964-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗