Clinical trial NCT06449664: Training for Men Undergoing Androgen Deprivation Therapy.
Official title: ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Androgen deprivation therapy (ADT)
Flywheel training
High intensity training (HIT)
Resistance training
Aerobic training
Lead sponsor: The Swedish School of Sport and Health Sciences
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
name: Karolinska Institutet
name: Prostate Cancer Foundation
name: Sahlgrenska University Hospital
First posted: 2024-06-10
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: 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 outcomes:
measure: Aerobic fitness
timeFrame: Baseline and after 6 and 12 weeks
measure: Maximal leg strength
timeFrame: Baseline and after 6 and 12 weeks
Secondary outcomes:
measure: Body fat
timeFrame: Baseline and after 6 and 12 weeks
measure: Lean body mass
timeFrame: Baseline and after 6 and 12 weeks
measure: Bone mineral density
timeFrame: Baseline and after 6 and 12 weeks
measure: Quadriceps cross-sectional area
timeFrame: Baseline and after 6 and 12 weeks
measure: Static balance
timeFrame: Baseline and after 6 and 12 weeks
measure: Walk capacity
timeFrame: Baseline and after 6 and 12 weeks
measure: Lower body muscular endurance
timeFrame: Baseline and after 6 and 12 weeks
measure: Blood pressure
timeFrame: Baseline and after 6 and 12 weeks
measure: Whole body glucose uptake
timeFrame: Baseline and after 6 and 12 weeks
measure: Whole body insulin response
timeFrame: Baseline and after 6 and 12 weeks
measure: Blood biomarkers related to cardiovascular disease.
timeFrame: Baseline and after 6 and 12 weeks
measure: Muscle fiber cross-sectional area (CSA)
timeFrame: Baseline and after 12 weeks
measure: Muscle fiber distribution
timeFrame: Baseline and after 12 weeks
measure: Capillary content
timeFrame: Baseline and after 12 weeks
measure: Myonuclei content
timeFrame: Baseline and after 12 weeks
measure: Satellite cell content
timeFrame: Baseline and after 12 weeks
measure: Mitochondrial content
timeFrame: Baseline and after 12 weeks
measure: Mitochondrial respiration
timeFrame: Baseline and after 12 weeks
measure: Genome-wide DNA methylation
timeFrame: Baseline and after 12 weeks
measure: Transcriptome-wide RNA expression
timeFrame: Baseline and after 12 weeks
measure: Protein expression
timeFrame: Baseline and after 12 weeks
measure: Gene expression
timeFrame: Baseline and after 12 weeks
measure: Cancer treatment-related symptoms
timeFrame: Baseline and after 6 and 12 weeks
measure: Physical activity
timeFrame: Baseline and after 6 and 12 weeks
measure: Physical and psychological health
timeFrame: Baseline and after 6 and 12 weeks
measure: Anxiety and depression
timeFrame: Baseline and after 6 and 12 weeks
measure: Cancer and treatment-related fatigue
timeFrame: Baseline and after 6 and 12 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Swedish School of Sport and Health Sciences
Study officials:
References: