Exercise and Quality of Life During Androgen Deprivation Therapy

Prostate Cancer Clinical Trial

Official title:

Exercise Intervention to Reduce Adverse Quality of Life Effects From Androgen Deprivation Therapy for Prostate Cancer - Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04050397
• Other study ID #: Patient School 1
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: August 15, 2021

Study information

• Verified date: September 2019
• Source: Tampere University Hospital
• Contact: Teemu Murtola, MD PhD
• Phone: +358 3 311 65015
• Email: teemu.murtola[@]tuni.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Progressive supervised weight training
12 weeks of progressive weight training twice a week supervised by a qualified physiotherapist.
• 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.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Varalan urheiluopisto

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to castration resistance	Time to castration resistance as defined by two consecutive rising PSA levels and increase of 50% or more from the nadir. Measured as months between the study recruitment and first record of castration resistance. Information obtained from patient files.	Followed yearly for up to 15 years from randomization
Other	Time to death	Time to death due to any cause. Measured as months between the study recruitment and date of death. Information obtained from patient files and national death certificate registry.	Followed yearly for up to 15 years from randomization
Other	Time to prostate cancer death	Time to death due to prostate cancer. Measured as months between the study recruitment and date of death. Information obtained from patient files and national death certificate registry.	Followed yearly for up to 15 years from randomization
Other	Bone fractures	Occurrence of any bone fracture requiring either conservative or operative management. Information obtained from patient files and national hospital discharge registry. Fracture site and it's management are recorded.	Followed yearly for up to 15 years from randomization
Primary	Daily total activity	Daily activity as measured by wrist activity monitor worn by the participants at all times during the study. Measured as metabolic equivalents of task (MET) units. Range from 0.9 to 23.	At randomization and twice more at 12 week intervals
Primary	Fasting plasma total cholesterol	Value measure in mmol/l	At randomization and twice more at 12 week intervals
Primary	Fasting plasma LDL cholesterol	Value measure in mmol/l	At randomization and twice more at 12 week intervals
Primary	Fasting plasma HDL cholesterol	Value measure in mmol/l	At randomization and twice more at 12 week intervals
Primary	Fasting plasma triglycerides	Value measure in mmol/l	At randomization and twice more at 12 week intervals
Primary	Fasting plasma glucose level	Value measured in mmol/l	At randomization and twice more at 12 week intervals
Primary	Blood glycated hemoglobin (HbA1C) level	Value measured in mmol/mol	At randomization and twice more at 12 week intervals
Primary	Overall quality of life	Score from validated survey EORTC QLQ-C30, score range from 0-100, with 100 denoting the highest quality of life	At randomization and twice more at 12 week intervals
Primary	Prostate cancer-specific quality of life	Score from validated survey EORTC QLQ-PR25, score range from 0-100, with 100 denoting the highest quality of life	At randomization and twice more at 12 week intervals
Secondary	Change in daily activity after the intervention	Change in daily activity of the supervised exercise group after completion of 12 weeks of supervised exercise as measured by wrist activity monitor in MET units, range from 0.9 to 23.	Measured daily for 12 weeks' time after the intervention
Secondary	Subjective adverse effects of castration treatment	The effect of supervised exercise on subjective adverse effects of castration treatment for prostate cancer. Qualitative assessment in three individual interviews and one group interview. No scaling used as this is a qualitative rather than quantitative end-point	At randomization and twice more at 12 week intervals
Secondary	Lean body mass	Bioimpedance-based measurement of lean body mass as percentage of total body mass measured with TANITA MC-780 device	At randomization and twice more at 12 week intervals
Secondary	Muscle mass	Bioimpedance-based measurement of muscle mass as percentage of total body mass measured with TANITA MC-780 device	At randomization and twice more at 12 week intervals
Secondary	Skeletal mass	Bioimpedance-based measurement of skeletal mass as percentage of total body mass measured with TANITA MC-780 device measured with TANITA MC-780 device	At randomization and twice more at 12 week intervals
Secondary	Fat mass	Bioimpedance-based measurement of fat mass as percentage of total body mass measured with TANITA MC-780 device measured with TANITA MC-780 device	At randomization and twice more at 12 week intervals
Secondary	Metabolic age	Metabolic age measured with bioimpedance-based TANITA MC-780 device	At randomization and twice more at 12 week intervals
Secondary	Systolic blood pressure	Value measured in mmHg	At randomization and twice more at 12 week intervals
Secondary	Diastolic blood pressure	Value measured in mmHg	At randomization and twice more at 12 week intervals