Exercise and Quality of Life During Androgen Deprivation Therapy

NCT ID: NCT04050397

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2021-08-15

Brief Summary

This study evaluates effects of supervised exercise in reducing adverse effects of hormonal treatment, increasing quality of life and in inducing a long-term change into more active lifestyle in prostate cancer patients on androgen deprivation therapy. All participants will attend a starting lecture at the beginning of the trial, after which they are randomly allocated to attend 3 months of either supervised or non-supervised exercise program. Leisure time activity, quality of life, blood sugar and cholesterol values, and body composition of participants will be evaluated at three time-points; at recruitment, after 12 weeks and after 24 weeks. Effects on quality of life will also be qualitatively evaluated with single- and group interviews.

Detailed Description

Androgen deprivation therapy (ADT) is commonly used in management of advanced or recurrent prostate cancer. It also frequently used adjuvant to curative-intent radiation therapy for localized prostate cancer. Low testosterone levels during androgen deprivation commonly cause adverse effects reducing quality of life. Most common adverse effects include fatigue, weight gain, loss of lean muscle mass, hyperglycemia and hypercholesterolemia.

Regular exercise, especially programs involving combination of both aerobic exercise and resistance training has been shown to reduce to reduce adverse effects of ADT on physical functioning and quality of life. It may also improve disease prognosis.

The study compares effects of supervised and unsupervised exercise on plasma lipid parameters (total cholesterol, LDL, HDL and triglycerides) and glucose levels (fasting plasma glucose, glycated hemoglobin), overall quality of life and on average daily exercise activity in men with prostate cancer and under ADT. As secondary outcome we will study effect on continued exercise activity after the intervention, changes in body composition, blood pressure and risk of fractures, castration resistance as well as death due to prostate cancer and due to any cause.

Study hypothesis is that supervised exercise will improve quality of life, lipid and glucose parameters and increase daily exercise activity more that non-supervised exercise. We also expect higher continued exercise activity, greater changes in body composition and blood pressure and lowered risk of fractures and death in the supervised exercise group.

This is a randomized, controlled clinical trial. The study aims to recruit 40 men on ADT for prostate cancer. This will be a pilot study to estimate effect sizes in Finnish population to inform further larger trial.

All participants attend introductory lecture, where a urologist informs them about adverse effects of ADT and positive effects of exercise during ADT, exercise instructor gives advice for training both at home and in the gym and nutritional therapeutist tells about nutrition to overcome adverse effects of ADT and support training.

After the introductory lecture the participants are randomized 1:1 to either the supervised or non-supervised exercise group (Figure). Men in the supervised group participate in progressive group exercise sessions twice a week for total of 12 weeks at the Varala sports academy in Tampere, Finland. Each exercise session includes both aerobic and resistance training targeting all major muscle groups (Additional document I, exercise program). The non-supervised group will exercise independently for 12 weeks according to the instructions given at the introductory lecture. The first control visit will be after this first period of 12 weeks of exercise.

After the first follow-up visit both group will continue non-supervised exercise for 12 weeks, after which the second control visit will be arranged. Special focus on the second control visit is to see how many in each group has been able to carry on active exercising, i.e. has the intervention promoted long-term change in exercise activity.

Both study group will be given Polar wrist activity monitors to be used 24 h/day for the entire course of the study.

All participants are asked to fill validated quality of life surveys EORTC QLQC-30 (overall quality of life) and EORTC QLQC-PR25 (prostate cancer-specific quality of life) at baseline and again at 1st and 2nd control visits. Additionally, qualitative evaluation of quality of life as well as perceived possibilities and obstacles for exercise are evaluated in individual- and group interviews during the study visits. Plasma lipid and glucose parameters, blood pressure and body composition will be measured at each of these visits.

At each visit a separate blood sample is taken and stored for future measurement of biomarkers associated with prostate cancer progression, glucose and lipid metabolism and effects of exercise.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Supervised exercise arm

Informational initiation lecture and supervised exercise twice a week for 12 weeks followed by 12 weeks of non-supervised exercise.

Group Type: EXPERIMENTAL

Progressive supervised weight training

Intervention Type: OTHER

12 weeks of progressive weight training twice a week supervised by a qualified physiotherapist.

Lecture

Intervention Type: OTHER

Urologist informs participants on adverse effects of castration treatments and benefits of regular exercise. Physiotherapist gives an exercise program to follow at home, and nutritionist informs patients on correct nutrition to assist physical exercise.

Non-supervised exercise arm

Informational initiation lecture and only non-supervised exercise

Group Type: ACTIVE_COMPARATOR

Lecture

Intervention Type: OTHER

Urologist informs participants on adverse effects of castration treatments and benefits of regular exercise. Physiotherapist gives an exercise program to follow at home, and nutritionist informs patients on correct nutrition to assist physical exercise.

Interventions

Progressive supervised weight training

12 weeks of progressive weight training twice a week supervised by a qualified physiotherapist.

Intervention Type: OTHER

Lecture

Urologist informs participants on adverse effects of castration treatments and benefits of regular exercise. Physiotherapist gives an exercise program to follow at home, and nutritionist informs patients on correct nutrition to assist physical exercise.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Undergoing castration treatment for prostate cancer
• Informed consent for the study

Exclusion Criteria

• Unable to participate in exercise (ECOG 2 or greater)
• High bone fracture risk (as judged by the primary physician)
• Unable to understand spoken and written instructions in Finnish

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Varalan urheiluopisto

UNKNOWN

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teemu Murtola, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Tampereen University, Faculty of Medicine and Health Technology

Locations

Tampere University Hospital

Tampere, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Teemu Murtola, MD PhD

Role: CONTACT

teemu.murtola@tuni.fi

+358 3 311 65015

Teuvo Tammela, MD PhD

Role: CONTACT

teuvo.tammela@tuni.fi

+358 3 311 64621

Facility Contacts

Teemu Murtola, MD, PhD

Role: primary

teemu.murtola@tuni.fi

+358 3 311 65015

Teuvo Tammela, MD PhD

Role: backup

teuvo.tammela@tuni.fi

+358 3 311 64621

References

Rantaniemi L, Jussila I, Siltari A, Ahtiainen JP, Hakulinen A, Harju E, Sormunen J, Nordstrom T, Tammela TLJ, Murtola TJ. Is Exercise During Androgen Deprivation Therapy Effective and Safe? A Randomized Controlled Trial. Scand J Med Sci Sports. 2025 Jun;35(6):e70084. doi: 10.1111/sms.70084.

Reference Type: DERIVED

PMID: 40481694 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Patient School 1

Identifier Type: -

Identifier Source: org_study_id