Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06449664 (ADT-train) for Prostate Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One trial matched filter criteria
Card View
Training for Men Undergoing Androgen Deprivation Therapy. (ADT-train)
Clinical Trial NCT06449664 (ADT-train) is an interventional study for Prostate Cancer that is recruiting. It started on May 1, 2024 with plans to enroll 60 participants. Led by The Swedish School of Sport and Health Sciences, it is expected to complete by December 20, 2028. The latest data from ClinicalTrials.gov was last updated on June 10, 2024.
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).
Official Title
ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.
Conditions
Prostate CancerOther Study IDs
- ADT-train
- 2024-00964-01
NCT ID Number
Start Date (Actual)
2024-05-01
Last Update Posted
2024-06-10
Completion Date (Estimated)
2028-12-20
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Androgen deprivation therapy (ADT)
Flywheel training
High intensity training (HIT)
Resistance training
Aerobic training
Flywheel training
High intensity training (HIT)
Resistance training
Aerobic training
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExercise The participants will exercise twice weekly performing the newly developed training concept including flywheel resistance training followed by aerobic cycling intervals. | ADT-TRAIN A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy |
No InterventionControl group The participants will receive usual care only. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Aerobic fitness | VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer | Baseline and after 6 and 12 weeks |
Maximal leg strength | Isometric squat test (N) measured on force plates | Baseline and after 6 and 12 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Body fat | Assessed by dual-energy x-ray absorptiometry (DEXA) (kg) | Baseline and after 6 and 12 weeks |
Lean body mass | Assessed by dual-energy x-ray absorptiometry (DEXA) (kg) | Baseline and after 6 and 12 weeks |
Bone mineral density | Assessed by dual-energy x-ray absorptiometry (DEXA) (g/cm2) | Baseline and after 6 and 12 weeks |
Quadriceps cross-sectional area | Assessed by ultrasound (mm) | Baseline and after 6 and 12 weeks |
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 |
Walk capacity | Usual and fast pace 6m walk test (s) | Baseline and after 6 and 12 weeks |
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 |
Blood pressure | Assessed by an automated blood pressure monitor (mmHg). | Baseline and after 6 and 12 weeks |
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 |
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 |
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 |
Muscle fiber cross-sectional area (CSA) | Type I and type II muscle CSA will be assessed by immunohistochemistry (µm2). | Baseline and after 12 weeks |
Muscle fiber distribution | Type I and type II muscle fiber distribution will be assessed by immunohistochemistry (%). | Baseline and after 12 weeks |
Capillary content | The number of capillaries per muscle fiber will be assessed by immunohistochemistry. | Baseline and after 12 weeks |
Myonuclei content | The number of myonuclei per muscle fiber CSA will be assessed by immunohistochemistry. | Baseline and after 12 weeks |
Satellite cell content | The number of satellite cells per muscle fiber CSA will be assessed by immunohistochemistry. | Baseline and after 12 weeks |
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 |
Mitochondrial respiration | Mitochondrial respiration will be assessed by respirometry of permeabilized muscle fibers (respiration ratio). | Baseline and after 12 weeks |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
Male
- 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.
- 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
The Swedish School of Sport and Health Sciences- 🏛️Norwegian School of Sport Sciences
Karolinska Institutet460 active trials to explore- 🧬Prostate Cancer Foundation
- 🏥Sahlgrenska University Hospital
Study Central Contact
Contact: Niklas Psilander, PhD, +46 8 120 538 23, [email protected]
1 Study Locations in 1 Countries
Swedish School of Sport and Health Sciences, Stockholm, 11486, Sweden
Niklas Psilander, PhD, Contact, +46 8 120 538 23, [email protected]
Niklas Psilander, PhD, Principal Investigator
Recruiting