High Impact Training to Patients with Prostate Cancer and Bone Metastases
Recruiting · NCT06259279 · Interventional (participants receive a specific treatment) · Lead sponsor: Copenhagen University Hospital at Herlev
View the official record on ClinicalTrials.gov →Interventions studied
High intensity high impact exercise intervention
What this trial is 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).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Herlev and Gentofte Hospital - Herlev, Herlev, Denmark