Training for Men Undergoing Androgen Deprivation Therapy.

Prostate Cancer Clinical Trial

— ADT-train  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449664
• Other study ID #: 2024-00964-01
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 20, 2028

Study information

• Verified date: June 2024
• Source: The Swedish School of Sport and Health Sciences
• Contact: Niklas Psilander, PhD
• Phone: +46 8 120 538 23
• Email: niklas.psilander[@]gih.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 20, 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Sweden	Swedish School of Sport and Health Sciences	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
The Swedish School of Sport and Health Sciences	Karolinska Institutet, Norwegian School of Sport Sciences, Prostate Cancer Foundation, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic fitness	VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer	Baseline and after 6 and 12 weeks
Primary	Maximal leg strength	Isometric squat test (N) measured on force plates	Baseline and after 6 and 12 weeks
Secondary	Body fat	Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)	Baseline and after 6 and 12 weeks
Secondary	Lean body mass	Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)	Baseline and after 6 and 12 weeks
Secondary	Bone mineral density	Assessed by dual-energy x-ray absorptiometry (DEXA) (g/cm2)	Baseline and after 6 and 12 weeks
Secondary	Quadriceps cross-sectional area	Assessed by ultrasound (mm)	Baseline and after 6 and 12 weeks
Secondary	Static balance	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
Secondary	Walk capacity	Usual and fast pace 6m walk test (s)	Baseline and after 6 and 12 weeks
Secondary	Lower body muscular endurance	30 s chair stand test. Maximal number of sit-to-stand repetitions during 30 s.	Baseline and after 6 and 12 weeks
Secondary	Blood pressure	Assessed by an automated blood pressure monitor (mmHg).	Baseline and after 6 and 12 weeks
Secondary	Whole body glucose uptake	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
Secondary	Whole body insulin response	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
Secondary	Blood biomarkers related to cardiovascular disease.	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
Secondary	Muscle fiber cross-sectional area (CSA)	Type I and type II muscle CSA will be assessed by immunohistochemistry (µm2).	Baseline and after 12 weeks
Secondary	Muscle fiber distribution	Type I and type II muscle fiber distribution will be assessed by immunohistochemistry (%).	Baseline and after 12 weeks
Secondary	Capillary content	The number of capillaries per muscle fiber will be assessed by immunohistochemistry.	Baseline and after 12 weeks
Secondary	Myonuclei content	The number of myonuclei per muscle fiber CSA will be assessed by immunohistochemistry.	Baseline and after 12 weeks
Secondary	Satellite cell content	The number of satellite cells per muscle fiber CSA will be assessed by immunohistochemistry.	Baseline and after 12 weeks
Secondary	Mitochondrial content	Mitochondrial content will be assessed by measuring citrate synthase activity in homogenized muscle samples (mmol/kg/dw/min).	Baseline and after 12 weeks
Secondary	Mitochondrial respiration	Mitochondrial respiration will be assessed by respirometry of permeabilized muscle fibers (respiration ratio).	Baseline and after 12 weeks
Secondary	Genome-wide DNA methylation	Assessed by Illumina EPIC arrays to identify epigenetically regulated genes and pathways associated with exercise and the ADT-treatment.	Baseline and after 12 weeks
Secondary	Transcriptome-wide RNA expression	Assessed by RNA-sequencing to identify differently regulated genes and pathways associated with exercise and the ADT-treatment.	Baseline and after 12 weeks
Secondary	Protein expression	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
Secondary	Gene expression	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
Secondary	Cancer treatment-related symptoms	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
Secondary	Physical activity	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
Secondary	Physical and psychological health	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
Secondary	Anxiety and depression	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
Secondary	Cancer and treatment-related fatigue	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