Clinical trial NCT06259279: High Impact Training to Patients with Prostate Cancer and Bone Metastases
Official title: High Impact Training to Patients with Prostate Cancer and Bone Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: bone metastases
exercise
bone mineral density
resistance and impact training
antitumor immunity
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: SUPPORTIVE_CARE

Brief summary: HIP is a randomized controlled trial. The aim is investigate the effect, safety and feasibility of brief, high-impact exercise targeting bones in patients with prostate cancer and bone metastases. Furthermore, to investigate the effects of the intervention on bone status (bone mineral density) and body composition, physical function and performance, patient reported quality-of-life outcomes, falls and hospitalizations. The effects of resistance training on the antitumor immunity will be assessed in the peripheral blood and tumor biopsies (HIPimmune).

Detailed description: Participants assigned to the intervention group will participate in a 32-week, twice-weekly, 30-minute, supervised HIP program at the hospital in Herlev, Denmark. To ensure a safe transition to high-intensity exercise, the first eight weeks of the intervention includes self-bodyweight and low-impact variations with a focus on getting used to use weight training equipment and gradually learning the movement patterns of the HIP exercises. All participants should be able to perform the four basic exercises of the intervention within two months. The resistance exercises (deadlift, overhead press, and squats) will be performed in five sets of five repetitions for the remaining intervention period, maintaining an intensity of \> 80% to 85% of 1 repetition maximum (RM). Blood samples and tumor biopsies will be taken at different timepoints of the exercise intervention (HIPimmune) and analyzed for lymphocyte entitumor responses.

Eligibility criteria: Inclusion Criteria:

* Patients with metastatic hormone sensitive prostate cancer (mHSPC)
* Patients must have bone metastases according to the most recent imaging (Bone scan, CT, MRI and/or PET)
* Patients must be treated with androgen deprivation therapy (ADT) (orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist or antagonist treatment) started \< 12 months ago. Additional treatment in the mHSPC setting, i.e., radiotherapy (RT) of the prostate, novel hormone agents (NHA) and/or docetaxel is permitted
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score \<2
* Patients must be able to speak and read Danish and provide a signed informed consent form
* Patients must be ambulatory without walking aids

Exclusion Criteria:

* Patients with any physical condition that interferes with the performance of physical exercise training
* Patients with presence of any musculoskeletal, cardiovascular, or neurologic conditions that may prevent patients from exercising
* Patients with bone pain requiring opioids
* Patients with planned or prior palliative radiation therapy to the bone
* Patients with major surgery within the past 6 months

HIPimmune: all patients included in HIP are eligible for HIPimmune

Primary outcomes:
measure: Lower body strength measured with the 30-second chair stand test (30s-CST)
timeFrame: baseline, 16 weeks, 32 weeks and 44 weeks
Secondary outcomes:
measure: Fat free mass (kg)
timeFrame: Change measures baseline, 32 weeks
measure: Body fat (% and kg)
timeFrame: Change measures baseline, 32 weeks
measure: Whole Body (BMC, g)
timeFrame: Change measures baseline, 32 weeks
measure: Whole Body (BMD, g/cm2)
timeFrame: Change measures baseline, 32 weeks
measure: Whole body T-score
timeFrame: Change measures baseline, 32 weeks
measure: Lumbar spine (L1-L4 BMD, g/cm2)
timeFrame: Change measures baseline, 32 weeks
measure: Lumbar spine T-score
timeFrame: Change measures baseline, 32 weeks
measure: Total Hip BMD, g/cm2
timeFrame: Change measures baseline, 32 weeks
measure: Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score
timeFrame: Change measures baseline, 32 weeks
measure: Total hip T-score
timeFrame: Change measures baseline, 32 weeks
measure: Os Calcis BMD, g/cm2
timeFrame: Change measures baseline, 32 weeks
measure: Os calcis T-score
timeFrame: Change measures baseline, 32 weeks
measure: Handgrip strength
timeFrame: baseline, 16 weeks, 32 weeks and 44 weeks
measure: Quality of life (QOL)
timeFrame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks
measure: Fatigue
timeFrame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks
measure: Safety (adverse events)
timeFrame: Through study completion, an average of 1 year
measure: Hospitalizations
timeFrame: Through study completion, an average of 1 year
measure: Hospitalizations, causes
timeFrame: Through study completion, an average of 1 year
measure: Hospitalizations, length of hospitalizations
timeFrame: Through study completion, an average of 1 year
measure: Falls
timeFrame: Through study completion, an average of 1 year
measure: Feasibility measured by dropout
timeFrame: Through study completion, an average of 1 year
measure: Feasibility measured by recruitment
timeFrame: Through study completion, an average of 1 year
measure: Feasibility measured by adherence.
timeFrame: Through study completion, an average of 1 year
measure: Physical activity
timeFrame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks
measure: Qualitative assessment of patients' experiences
timeFrame: Up to 6 months after study completion
measure: HIPimmune: Immune response in peripheral blood and tumor
timeFrame: Baseline, week 8, week 32, week 44
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Anne-Mette Ragle, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Peter Østergren
name: Peter B Østergren
role: STUDY_DIRECTOR
affiliation: University Hospital Copenhagen Herlev, National Center for Cancer Immune Therapy (CCIT)
name: Katharina Leuchte, Dr. med.
role: STUDY_DIRECTOR
References: