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
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
Treatments tested in this trial
- High intensity high impact exercise intervention
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov