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

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Stockholm, Sweden, 11486
        • Recruiting
        • Swedish School of Sport and Health Sciences
        • Contact:
        • Principal Investigator:
          • Niklas Psilander, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
The participants will exercise twice weekly performing the newly developed training concept including flywheel resistance training followed by aerobic cycling intervals.
A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy
No Intervention: Control group
The participants will receive usual care only.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat
Time Frame: Baseline and after 6 and 12 weeks
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Baseline and after 6 and 12 weeks
Lean body mass
Time Frame: Baseline and after 6 and 12 weeks
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Baseline and after 6 and 12 weeks
Bone mineral density
Time Frame: Baseline and after 6 and 12 weeks
Assessed by dual-energy x-ray absorptiometry (DEXA) (g/cm2)
Baseline and after 6 and 12 weeks
Quadriceps cross-sectional area
Time Frame: Baseline and after 6 and 12 weeks
Assessed by ultrasound (mm)
Baseline and after 6 and 12 weeks
Static balance
Time Frame: Baseline and after 6 and 12 weeks
One leg balance test on the right and the left foot. Time to first footing is measured and the number of footings during 60s.
Baseline and after 6 and 12 weeks
Walk capacity
Time Frame: Baseline and after 6 and 12 weeks
Usual and fast pace 6m walk test (s)
Baseline and after 6 and 12 weeks
Lower body muscular endurance
Time Frame: Baseline and after 6 and 12 weeks
30 s chair stand test. Maximal number of sit-to-stand repetitions during 30 s.
Baseline and after 6 and 12 weeks
Blood pressure
Time Frame: Baseline and after 6 and 12 weeks
Assessed by an automated blood pressure monitor (mmHg).
Baseline and after 6 and 12 weeks
Whole body glucose uptake
Time Frame: Baseline and after 6 and 12 weeks
Assessed by an oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood glucose levels will be monitored throughout a period of 2 hours (mmol/L).
Baseline and after 6 and 12 weeks
Whole body insulin response
Time Frame: Baseline and after 6 and 12 weeks
Assessed by an oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood insulin levels will be monitored throughout a period of 2 hours (μU/mL).
Baseline and after 6 and 12 weeks
Blood biomarkers related to cardiovascular disease.
Time Frame: Baseline and after 6 and 12 weeks
Assessed by high-multiplex immunoassays quantifying proteins associated with biological functions linked to cardiovascular diseases. Approximately 100 proteins will be assessed. Examples of proteins are: C-Reactive Protein (CRP), Tissue Factor (F3), and Thrombomodulin (THBD).
Baseline and after 6 and 12 weeks
Muscle fiber cross-sectional area (CSA)
Time Frame: Baseline and after 12 weeks
Type I and type II muscle CSA will be assessed by immunohistochemistry (µm2).
Baseline and after 12 weeks
Muscle fiber distribution
Time Frame: Baseline and after 12 weeks
Type I and type II muscle fiber distribution will be assessed by immunohistochemistry (%).
Baseline and after 12 weeks
Capillary content
Time Frame: Baseline and after 12 weeks
The number of capillaries per muscle fiber will be assessed by immunohistochemistry.
Baseline and after 12 weeks
Myonuclei content
Time Frame: Baseline and after 12 weeks
The number of myonuclei per muscle fiber CSA will be assessed by immunohistochemistry.
Baseline and after 12 weeks
Satellite cell content
Time Frame: Baseline and after 12 weeks
The number of satellite cells per muscle fiber CSA will be assessed by immunohistochemistry.
Baseline and after 12 weeks
Mitochondrial content
Time Frame: Baseline and after 12 weeks
Mitochondrial content will be assessed by measuring citrate synthase activity in homogenized muscle samples (mmol/kg/dw/min).
Baseline and after 12 weeks
Mitochondrial respiration
Time Frame: Baseline and after 12 weeks
Mitochondrial respiration will be assessed by respirometry of permeabilized muscle fibers (respiration ratio).
Baseline and after 12 weeks
Genome-wide DNA methylation
Time Frame: Baseline and after 12 weeks
Assessed by Illumina EPIC arrays to identify epigenetically regulated genes and pathways associated with exercise and the ADT-treatment.
Baseline and after 12 weeks
Transcriptome-wide RNA expression
Time Frame: Baseline and after 12 weeks
Assessed by RNA-sequencing to identify differently regulated genes and pathways associated with exercise and the ADT-treatment.
Baseline and after 12 weeks
Protein expression
Time Frame: Baseline and after 12 weeks
Assessed by Western Blot and ELISA (AU). This could for example be proteins related to genes identified by the genome-wide DNA methylation analysis or transcriptome-wide RNA expression analysis.
Baseline and after 12 weeks
Gene expression
Time Frame: Baseline and after 12 weeks
Assessed by quantitative real-time PCR (AU). This could for example be genes identified by the genome-wide DNA methylation analysis or transcriptome-wide RNA expression analysis.
Baseline and after 12 weeks
Cancer treatment-related symptoms
Time Frame: Baseline and after 6 and 12 weeks
Assessed by the National Prostate Cancer Register (NPCR) form. Scores scaled from 0 to 7. A higher score indicates more severe symptoms.
Baseline and after 6 and 12 weeks
Physical activity
Time Frame: Baseline and after 6 and 12 weeks
Assessed by the physical activity questionnaire. Scores scaled from 1 to 8. A higher score indicates a more physically active participant.
Baseline and after 6 and 12 weeks
Physical and psychological health
Time Frame: Baseline and after 6 and 12 weeks
Assessed by the Short Form Health Survey (SF-36). Scores scaled from 1 to 6. A higher score indicates better physical and psychological health.
Baseline and after 6 and 12 weeks
Anxiety and depression
Time Frame: Baseline and after 6 and 12 weeks
Assessed by the Hospital Anxiety and Depression Scale (HADS). Scores scaled from 0 to 3. A higher score indicates more anxiety and depression.
Baseline and after 6 and 12 weeks
Cancer and treatment-related fatigue
Time Frame: Baseline and after 6 and 12 weeks
Assessed by the Multidimensional Fatigue Inventory survey (MFI-20). Scores scaled from 1 to 5. A higher score indicates more fatigue.
Baseline and after 6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 20, 2028

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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