In a nutshell
This phase 2 trial aims to compare the benefit of two types of exercise for men with metastatic castration-resistant prostate cancer. The main outcome to be investigated is the safety of the exercises and its effect on cancer pain. The trial is recruiting in San Francisco (California).
The details
Metastatic castration-resistant prostate cancer (mCRPC) is prostate cancer that continues to spread despite standard hormone therapy. mCRPC is considered advanced and is associated with rapid disease progression. Advances in treatment options for mCRPC have improved survival in recent years. However, there is a continued need for effective interventions to improve cancer pain and quality of life for men with late stage disease.
This study will examine the benefit of aerobic exercise (mainly cardio) and resistance exercise (mainly strength training) compared to no additional exercise regime in men with mCRPC. Both exercise regimes will be supervised and last a total of 12 weeks. The safety and tolerability will be recorded for up to 3 months. Questionnaires will measure changes in cancer pain, physical and psychological symptoms, and quality of life during the same time period.
Who are they looking for?
This study will recruit about 60 men with metastatic prostate cancer no longer responding to standard hormone therapy (drug therapy or testicle removal). Participants should have very low (near castration) testosterone levels. Prostate cancer should be progressive with rising PSA levels (prostate specific antigens; a protein elevated in the blood in prostate cancer). Participants will be required to continue standard hormone drug therapy during the study period. Full blood counts will be assessed before taking part. Participants must be able to undertake vigorous physical activity.
Participants cannot take part in the trial if the cancer has spread to the brain. Any chemotherapy since the diagnosis of mCRPC is not permitted. 4 weeks or more should have passed since the last major surgery. Patients should not have uncontrolled high blood pressure, an active infection, a non-healing wound, ulcer or fracture, previous or current heart conditions, shortness of breath, chest pain, palpitations, or any other medical condition that would endanger the undertaking of physical activity. Participants should not have spinal cord compression or any other complications from bone metastases, or experience significant cancer pain.
How will it work
Participants will be randomly assigned to either undergo 12 weeks of aerobic exercise, resistance exercise, or usual care (control group).
Aerobic exercise will consist of 3 supervised sessions per week. Each session will consist of two high-intensity interval training workouts and 1 continuous vigorous intensity workout.
Resistance exercise will also consist of 3 supervised sessions per week. Each session will consist of strength training with high load/low volume, light load/high volume, and moderate load/moderate volume.
The control group will follow their usual exercise and lifestyle routine.
A physical assessment, physical function and strengths tests, questionnaires, and diet diaries will be completed before the study and at 3 months. Questionnaires will measure side effects, exercise tolerance, general pain, bone pain, quality of life, fatigue, general anxiety, and general depression.
Clinical trial locations
| Type: | Interventional |
| Participants: | 28 |
| Study ID: | NCT02613273 |
