Exercise and Quality of Life During Androgen Deprivation Therapy

NCT04050397 | Unknown

• 1 other identifier: Patient School 1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

androgen deprivation therapy; exercise; quality of life; blood glucose; cholesterol; prostate cancer

Outcome Measures

Primary Outcomes (9)

• 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

• Fasting plasma total cholesterol

  Value measure in mmol/l

  At randomization and twice more at 12 week intervals

• Fasting plasma LDL cholesterol

  Value measure in mmol/l

  At randomization and twice more at 12 week intervals

• Fasting plasma HDL cholesterol

  Value measure in mmol/l

  At randomization and twice more at 12 week intervals

• Fasting plasma triglycerides

  Value measure in mmol/l

  At randomization and twice more at 12 week intervals

• Fasting plasma glucose level

  Value measured in mmol/l

  At randomization and twice more at 12 week intervals

• Blood glycated hemoglobin (HbA1C) level

  Value measured in mmol/mol

  At randomization and twice more at 12 week intervals

• 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

• 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 Outcomes (9)

• Change in daily activity after the intervention

  Measured daily for 12 weeks' time after the intervention

• Subjective adverse effects of castration treatment

  At randomization and twice more at 12 week intervals

• Lean body mass

  At randomization and twice more at 12 week intervals

• Muscle mass

  At randomization and twice more at 12 week intervals

• Skeletal mass

  At randomization and twice more at 12 week intervals

Other Outcomes (4)

• Time to castration resistance

  Followed yearly for up to 15 years from randomization

• Time to death

  Followed yearly for up to 15 years from randomization

• Time to prostate cancer death

  Followed yearly for up to 15 years from randomization

Study Arms (2)

Supervised exercise arm

EXPERIMENTAL

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

Other: Progressive supervised weight training; Other: Lecture

Non-supervised exercise arm

ACTIVE COMPARATOR

Informational initiation lecture and only non-supervised exercise

Other: Lecture

Interventions

Progressive supervised weight training OTHER

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

Supervised exercise arm

Lecture 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; Supervised exercise arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Varalan urheiluopisto: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

RECRUITING

Related Publications (1)

• 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.

  PMID: 40481694 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Teemu Murtola, MD PhD

  Tampereen University, Faculty of Medicine and Health Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teemu Murtola, MD PhD

CONTACT

+358 3 311 65015; teemu.murtola@tuni.fi

Teuvo Tammela, MD PhD

CONTACT

+358 3 311 64621; teuvo.tammela@tuni.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participant will be randomized 1:1 to either supervised exercise for 12 weeks or to follow given exercise program on their own.

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: August 8, 2019
• Study Start: August 15, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2021
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)