Training for Men Undergoing Androgen Deprivation Therapy. (ADT-train)

The Swedish School of Sport and Health Sciences

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Behavioral: ADT-train

Study type: Interventional

Funder types: Other

Identifiers

NCT06449664

2024-00964-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Exercise

Experimental group

Description:

The participants will exercise twice weekly performing the newly developed training concept including flywheel resistance training followed by aerobic cycling intervals.

Treatment:

Behavioral: ADT-train

Control group

No Intervention group

Description:

The participants will receive usual care only.