Clinical trial NCT04050397: Exercise and Quality of Life During Androgen Deprivation Therapy
Official title: Exercise Intervention to Reduce Adverse Quality of Life Effects From Androgen Deprivation Therapy for Prostate Cancer - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: androgen deprivation therapy
exercise
quality of life
blood glucose
cholesterol
prostate cancer
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Varalan urheiluopisto
First posted: 2019-08-08
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participant will be randomized 1:1 to either supervised exercise for 12 weeks or to follow given exercise program on their own.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Daily total activity
timeFrame: At randomization and twice more at 12 week intervals
measure: Fasting plasma total cholesterol
timeFrame: At randomization and twice more at 12 week intervals
measure: Fasting plasma LDL cholesterol
timeFrame: At randomization and twice more at 12 week intervals
measure: Fasting plasma HDL cholesterol
timeFrame: At randomization and twice more at 12 week intervals
measure: Fasting plasma triglycerides
timeFrame: At randomization and twice more at 12 week intervals
measure: Fasting plasma glucose level
timeFrame: At randomization and twice more at 12 week intervals
measure: Blood glycated hemoglobin (HbA1C) level
timeFrame: At randomization and twice more at 12 week intervals
measure: Overall quality of life
timeFrame: At randomization and twice more at 12 week intervals
measure: Prostate cancer-specific quality of life
timeFrame: At randomization and twice more at 12 week intervals
Secondary outcomes:
measure: Change in daily activity after the intervention
timeFrame: Measured daily for 12 weeks' time after the intervention
measure: Subjective adverse effects of castration treatment
timeFrame: At randomization and twice more at 12 week intervals
measure: Lean body mass
timeFrame: At randomization and twice more at 12 week intervals
measure: Muscle mass
timeFrame: At randomization and twice more at 12 week intervals
measure: Skeletal mass
timeFrame: At randomization and twice more at 12 week intervals
measure: Fat mass
timeFrame: At randomization and twice more at 12 week intervals
measure: Metabolic age
timeFrame: At randomization and twice more at 12 week intervals
measure: Systolic blood pressure
timeFrame: At randomization and twice more at 12 week intervals
measure: Diastolic blood pressure
timeFrame: At randomization and twice more at 12 week intervals
Other outcomes:
measure: Time to castration resistance
timeFrame: Followed yearly for up to 15 years from randomization
measure: Time to death
timeFrame: Followed yearly for up to 15 years from randomization
measure: Time to prostate cancer death
timeFrame: Followed yearly for up to 15 years from randomization
measure: Bone fractures
timeFrame: Followed yearly for up to 15 years from randomization
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampereen University, Faculty of Medicine and Health Technology
name: Teemu Murtola, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: