Exercise + Radiation Therapy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byNicholas Zaorsky, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Milton S. Hershey Medical Center
Disqualifiers: Heart failure, Coronary syndromes, Arrhythmias, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is being done to determine if patients receiving personalized exercise therapy (versus those who do not receive personalized exercise therapy) have improved quality of life and physical functioning after completing their radiation therapy. Second, the study is being done to find if the quality of life changes during therapy correlate with measurements of inflammation in the blood. Third, the study is being done to see if adding exercise therapy to radiation therapy will improve survival.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it allows for prior or current use of hormone therapy and chemotherapy agents, so you may not need to stop these treatments.
What data supports the effectiveness of the treatment Exercise + Radiation Therapy for Prostate Cancer?
Research shows that combining external beam radiation therapy with brachytherapy (a type of internal radiation) can reduce cancer recurrence in prostate cancer patients. This suggests that the radiation therapy component of the treatment may be effective in managing prostate cancer.
12345Is exercise combined with radiation therapy for prostate cancer safe?
Radiation therapy for prostate cancer, including external beam radiation and brachytherapy, has been studied for safety. Common side effects include issues with the urinary and digestive systems, but these are generally not severe. Exercise therapy is generally safe and can improve overall health, though specific safety data for its combination with radiation therapy is limited.
678910How does the Exercise + Radiation Therapy treatment for prostate cancer differ from other treatments?
This treatment is unique because it combines radiation therapy with exercise to help reduce fatigue and improve quality of life in prostate cancer patients. Exercise during radiation therapy has been shown to lessen treatment-related side effects, such as fatigue and rectal toxicity, making it a novel approach compared to standard radiation therapy alone.
1112131415Eligibility Criteria
This trial is for men over 18 with metastatic prostate cancer undergoing their first round of palliative radiation therapy. They must have had hormone therapy, be in a stable condition (ECOG ≤3), and speak English. Exclusions include severe heart conditions, respiratory failure, high fracture risk, heavy current exercisers (>90 min/week), or those treated outside the specified hospitals.Inclusion Criteria
Fluent in written and spoken English
I am scheduled for radiation therapy at University Hospitals in Cleveland or Lake Health Center.
I am receiving a specific radiation therapy dose or SBRT.
+5 more
Exclusion Criteria
I have had a heart attack or heart surgery in the last 6 months.
I am a man aged 18 or older.
I have experienced fainting spells.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Therapy
Participants receive standard of care radiation treatment, with or without exercise therapy
5 weeks
Daily visits for radiation treatment
Exercise Therapy
Participants in the experimental group receive personalized exercise therapy alongside radiation treatment
5 weeks
1-7 exercise sessions per week, depending on tolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment, including weekly follow-up calls for 4 weeks
4 weeks
Weekly phone calls
Participant Groups
The EXERT study tests if personalized exercise therapy during radiation treatment improves life quality and physical function in metastatic prostate cancer patients. It also examines whether exercise affects survival rates and correlates with inflammation markers in blood.
2Treatment groups
Experimental Treatment
Active Control
Group I: Radiation Therapy + Exercise TherapyExperimental Treatment1 Intervention
This group will receive exercise intervention in addition to their standard of care radiation treatment. At the baseline visit, they will meet with the certified exercise trainer (CET) and will be provided with a personalized exercise prescription and log to record what they do in between daily radiation treatment visits. The participant will also undergo an in-person exercise session prior to radiation therapy, which will take place either on the same day that the physical function tests are preformed or on a separate day. Participants will exercise between 1 and 7 times/week depending on the patient's tolerance to the exercise prescription. The CET will meet with the participant at every radiation treatment visit for an exercise counseling check-in. After five radiation treatments, the CET will follow-up with the participants via phone call once per week for 4 weeks during the follow-up period.
Group II: Radiation TherapyActive Control1 Intervention
The observational group will continue with their usual standard of care of radiation therapy. The study team will provide patients with an educational pamphlet at the end of their baseline visit. They will also be provided with a self-directed exercise program framework. Additionally, the participant's medical record will be reviewed for serious adverse events during their time on study. Baseline and final measurements will be obtained.
Radiation therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiotherapy for:
- Breast cancer
- Lung cancer
- Colorectal cancer
- Prostate cancer
- Brain tumors
- Skin cancer
🇺🇸 Approved in United States as Radiation therapy for:
- Breast cancer
- Lung cancer
- Colorectal cancer
- Prostate cancer
- Brain tumors
- Skin cancer
- Cervical cancer
- Uterine cancer
🇨🇦 Approved in Canada as Radiotherapy for:
- Breast cancer
- Lung cancer
- Colorectal cancer
- Prostate cancer
- Brain tumors
- Skin cancer
🇯🇵 Approved in Japan as Radiation therapy for:
- Breast cancer
- Lung cancer
- Colorectal cancer
- Prostate cancer
- Brain tumors
- Skin cancer
- Esophageal cancer
🇨🇳 Approved in China as Radiotherapy for:
- Breast cancer
- Lung cancer
- Colorectal cancer
- Prostate cancer
- Brain tumors
- Skin cancer
- Nasopharyngeal cancer
🇨🇭 Approved in Switzerland as Radiation therapy for:
- Breast cancer
- Lung cancer
- Colorectal cancer
- Prostate cancer
- Brain tumors
- Skin cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State Cancer InstituteHershey, PA
University Hospitals, 11100 Euclid AveCleveland, OH
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterCleveland, OH
Loading ...
Who Is Running the Clinical Trial?
Milton S. Hershey Medical CenterLead Sponsor
Case Comprehensive Cancer CenterLead Sponsor
References
Brachytherapy versus external beam radiotherapy boost for prostate cancer: Systematic review with meta-analysis of randomized trials. [2022]Brachytherapy boost after external beam radiotherapy for intermediate and high-risk prostate cancer is presented as an attractive technique in numerous retrospective and prospective studies. Currently, three randomized controlled trials comparing brachytherapy versus external beam radiotherapy boost used non-homogenous irradiation features. Therefore, we analyzed the oncological outcomes by a systematic review with meta-analysis of the randomized controlled trials.
Long-Term Results of NRG Oncology/RTOG 0321: A Phase II Trial of Combined High Dose Rate Brachytherapy and External Beam Radiation Therapy for Adenocarcinoma of the Prostate. [2022]To report the long-term outcome of patients with prostate cancer treated with external beam radiation therapy and high dose rate (HDR) brachytherapy from a prospective multi-institutional trial conducted by NRG Oncology/RTOG.
Lack of Apparent Survival Benefit With Use of Androgen Deprivation Therapy in Patients With High-risk Prostate Cancer Receiving Combined External Beam Radiation Therapy and Brachytherapy. [2018]Although level 1 evidence has demonstrated a survival benefit from the addition of androgen deprivation therapy (ADT) to external beam radiation therapy (EBRT) for patients with high-risk prostate cancer, the benefits of ADT with combined EBRT and brachytherapy for high-risk patients are unclear. We examined the association between ADT and overall survival in a national cohort of high-risk patients treated with EBRT with or without brachytherapy.
Impact of High-Dose-Rate and Low-Dose-Rate Brachytherapy Boost on Toxicity, Functional and Cancer Outcomes in Patients Receiving External Beam Radiation Therapy for Prostate Cancer: A National Population-Based Study. [2021]External beam radiation therapy (EBRT) with brachytherapy boost reduces cancer recurrence in patients with prostate cancer compared with EBRT monotherapy. However, randomized controlled trials or large-scale observational studies have not compared brachytherapy boost types directly.
Dose-Escalated Irradiation and Overall Survival in Men With Nonmetastatic Prostate Cancer. [2022]In 5 published randomized clinical trials, dose-escalated external-beam radiation therapy (EBRT) for prostate cancer resulted in improved biochemical and local control. However, scarce evidence addresses whether dose escalation improves overall survival.
[Intraoperative radiotherapy combined with external beam radiation for prostate cancer without metastasis]. [2011]Between 1989 and 1996, 35 patients with prostate cancer without metastasis received intraoperative radiotherapy combined with external beam radiation. 10 of 16 stage B patients and all of 19 stage C patients received additional endocrine therapy for the initial treatment. The radiation therapy included 25-30 Gy of intraoperative radiotherapy for prostate and 30 Gy of external beam radiotherapy for small pelvic region. One patient of stage C was dead for cancer and 4 patient were dead for other causes during 15-99 (mean: 41.6) months follow up period. The overall actuarial survival at 5 years by Kaplan-Meier method were 92.3% for stage B and 87.2% for stage C. Although cystitis, proctitis and anal bleeding were observed as the adverse effects of radiotherapy, both acute and chronic symptoms were not critical. In conclusion, intraoperative radiotherapy combined with external beam radiotherapy was revealed as an effective treatment for prostate cancer without metastasis.
Radiation therapy for prostate cancer. [2013]Radiation therapy is an effective treatment for newly diagnosed prostate cancer, salvage treatment, or for palliation of advanced disease. Herein we briefly discuss the indications, results, and complications associated with brachytherapy and external beam radiotherapy, when used as monotherapy and in combination with each other or androgen deprivation.
Assessing adverse events of postprostatectomy radiation therapy for prostate cancer: evaluation of outcomes in the Regione Emilia-Romagna, Italy. [2015]Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events.
Long-term results of an RTOG Phase II trial (00-19) of external-beam radiation therapy combined with permanent source brachytherapy for intermediate-risk clinically localized adenocarcinoma of the prostate. [2018]External-beam radiation therapy combined with low-doserate permanent brachytherapy are commonly used to treat men with localized prostate cancer. This Phase II trial was performed to document late gastrointestinal or genitourinary toxicity as well as biochemical control for this treatment in a multi-institutional cooperative group setting. This report defines the long-term results of this trial.
Long-term adverse effects after curative radiotherapy and radical prostatectomy: population-based nationwide register study. [2022]The aim of this study was to assess the risk of serious adverse effects after radiotherapy (RT) with curative intention and radical prostatectomy (RP).
The Impact of Exercise during Radiation Therapy for Prostate Cancer on Fatigue and Quality of Life: A Systematic Review and Meta-analysis. [2020]Radiation therapy (RT) is clinically proven to improve survival in men with prostate cancer. Despite these advantages, it is known to cause adverse effects such as fatigue. This review proposes to summarize the totality of evidence from randomized controlled trials regarding the effectiveness of exercise on fatigue in men with prostate cancer as a primary outcome. Quality of life was a secondary outcome.
Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. [2021]Exercise training has shown beneficial effects in the management of radiotherapy-related side effects in prostate cancer (PCa) patients undergoing radiation therapy (RT). However, the optimal modality of the exercise programs have not been yet determined. The aim of this randomized controlled trial was to investigate the effects of high-intensity interval training (HIIT) and resistance training (RES) compared to usual care (UC) on cancer-treatment-related fatigue (CTRF) (primary outcome), quality of life, depression, daytime sleepiness, insomnia, sleep quality, functional exercise capacity and executive function in PCa patients during RT.
Effect of Exercise Adjunct to Radiation and Androgen Deprivation Therapy on Patient-Reported Treatment Toxicity in Men With Prostate Cancer: A Secondary Analysis of 2 Randomized Controlled Trials. [2021]Physical inactivity, in addition to clinical factors, has been associated with higher levels of late pelvic symptoms in patients with prostate cancer (PCa) after radiation therapy. The aim of this study was to investigate the effect of a structured multicomponent exercise program comprised of aerobic and resistance training as well as impact loading on the prevalence and severity of symptoms commonly resulting from androgen deprivation therapy (ADT) and pelvic radiation therapy.
[The role of exercise in prostate cancer prevention and treatment]. [2019]As a result of the growing incidence of cancer as well as increased survival of patients, an increasing number of people are living longer with cancer. In recent years, research has shown that physical activity not only protects against a number of cancer types, but is also valuable for patients undergoing cancer treatment and during the rehabilitation phase, as well as for improving function and quality of life. Regular physical activity is an effective way to reduce the side effects of cancer, resulting in part from physical inactivity and in part from the disease itself. Too much rest can lead to a decrease in aerobic fitness, strength, mobility and unwanted weight gain in the patient. In prostate cancer patients, hormonal treatment especially accelerates this process. In this paper we summarize the available evidence concerning the role of exercise in prostate cancer prevention, treatment and rehabilitation.
The effect of aerobic exercise on treatment-related acute toxicity in men receiving radical external beam radiotherapy for localised prostate cancer. [2010]We retrospectively analysed acute radiation toxicity data for patients who had participated in a randomised controlled study in our centre in order to assess the impact of aerobic exercise on acute rectal and bladder morbidity during treatment. Data from 65 of 66 patients were analysed: 33 allocated into a control group (standard advice) and 33 into an exercise group (aerobic walking for 30 min at least three times per week) during 4 weeks of external beam radiotherapy; one patient in the exercise group withdrew after randomisation before starting radiotherapy. There was a trend towards less severe acute rectal toxicity in the exercise group with a statistically significant difference in mean toxicity scores over the 4 weeks of radiotherapy (P=0.004), with no significant difference in bladder toxicity scores between the two groups (P=0.123). The lack of an association for severity of bladder toxicity could be attributed to the confounding effect of lower urinary tract symptoms from their prostate cancer. Keeping active and being asked to adhere to a well-defined exercise schedule appears to reduce the severity of rectal toxicity during radiotherapy to the prostate.