High Impact Training to Patients with Prostate Cancer and Bone Metastases (HIP)

Copenhagen University Hospital at Herlev

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Behavioral: High intensity high impact exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06259279

AMRagle

Details and patient eligibility

About

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).

Full 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.

Enrollment: 102 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

102 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Patients in the intervention group will receive a 32-week exercise-based intervention that includes supervised and group-based exercise training in the hospital, twice a week. Each session lasts approximately 30 minutes.

Treatment:

Behavioral: High intensity high impact exercise intervention

Control Group

No Intervention group

Description:

standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes.