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High Impact Training to Patients with Prostate Cancer and Bone Metastases

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCopenhagen University Hospital at Herlev

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • High intensity high impact exercise intervention

    Behavioral

    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 groups

102 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Lower body strength measured with the 30-second chair stand test (30s-CST)

Number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest. The assesment will be conducted by blinded physiotherapist

Time frame
baseline, 16 weeks, 32 weeks and 44 weeks

Secondary outcomes

1

Fat free mass (kg)

Measured with DXA scans

Time frame
Change measures baseline, 32 weeks
2

Body fat (% and kg)

Measured with DXA scans

Time frame
Change measures baseline, 32 weeks
3

Whole Body (BMC, g)

Measured with DXA scans

Time frame
Change measures baseline, 32 weeks
4

Whole Body (BMD, g/cm2)

Measured with DXA scans

Time frame
Change measures baseline, 32 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Copenhagen University Hospital at Herlev

Lead sponsor

Source ClinicalTrials.gov
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