NCT06259279Recruiting
High Impact Training to Patients with Prostate Cancer and Bone Metastases
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 29 Jan 2024
- Start date
- 6 Feb 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Diseases
- Prostate cancer
- NCT number
- NCT06259279
What you commit to
- Study type: Interventional
- Planned participants: 102
- From 6 Feb 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Patients with bone pain requiring opioids
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herlev and Gentofte Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.