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Exercise and Quality of Life During Androgen Deprivation Therapy

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ClinicalTrials.gov Identifier: NCT04050397
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Varalan urheiluopisto
Information provided by (Responsible Party):
Tampere University Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Progressive supervised weight training Other: Lecture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Intervention to Reduce Adverse Quality of Life Effects From Androgen Deprivation Therapy for Prostate Cancer - Randomized Clinical Trial
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supervised exercise arm
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
12 weeks of progressive weight training twice a week supervised by a qualified physiotherapist.

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.

Active Comparator: Non-supervised exercise arm
Informational initiation lecture and only non-supervised exercise
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.




Primary Outcome Measures :
  1. Daily total activity [ Time Frame: At randomization and twice more at 12 week intervals ]
    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.

  2. Fasting plasma total cholesterol [ Time Frame: At randomization and twice more at 12 week intervals ]
    Value measure in mmol/l

  3. Fasting plasma LDL cholesterol [ Time Frame: At randomization and twice more at 12 week intervals ]
    Value measure in mmol/l

  4. Fasting plasma HDL cholesterol [ Time Frame: At randomization and twice more at 12 week intervals ]
    Value measure in mmol/l

  5. Fasting plasma triglycerides [ Time Frame: At randomization and twice more at 12 week intervals ]
    Value measure in mmol/l

  6. Fasting plasma glucose level [ Time Frame: At randomization and twice more at 12 week intervals ]
    Value measured in mmol/l

  7. Blood glycated hemoglobin (HbA1C) level [ Time Frame: At randomization and twice more at 12 week intervals ]
    Value measured in mmol/mol

  8. Overall quality of life [ Time Frame: At randomization and twice more at 12 week intervals ]
    Score from validated survey EORTC QLQ-C30, score range from 0-100, with 100 denoting the highest quality of life

  9. Prostate cancer-specific quality of life [ Time Frame: At randomization and twice more at 12 week intervals ]
    Score from validated survey EORTC QLQ-PR25, score range from 0-100, with 100 denoting the highest quality of life


Secondary Outcome Measures :
  1. Change in daily activity after the intervention [ Time Frame: Measured daily for 12 weeks' time 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.

  2. Subjective adverse effects of castration treatment [ Time Frame: At randomization and twice more at 12 week intervals ]
    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

  3. Lean body mass [ Time Frame: At randomization and twice more at 12 week intervals ]
    Bioimpedance-based measurement of lean body mass as percentage of total body mass measured with TANITA MC-780 device

  4. Muscle mass [ Time Frame: At randomization and twice more at 12 week intervals ]
    Bioimpedance-based measurement of muscle mass as percentage of total body mass measured with TANITA MC-780 device

  5. Skeletal mass [ Time Frame: At randomization and twice more at 12 week intervals ]
    Bioimpedance-based measurement of skeletal mass as percentage of total body mass measured with TANITA MC-780 device measured with TANITA MC-780 device

  6. Fat mass [ Time Frame: At randomization and twice more at 12 week intervals ]
    Bioimpedance-based measurement of fat mass as percentage of total body mass measured with TANITA MC-780 device measured with TANITA MC-780 device

  7. Metabolic age [ Time Frame: At randomization and twice more at 12 week intervals ]
    Metabolic age measured with bioimpedance-based TANITA MC-780 device

  8. Systolic blood pressure [ Time Frame: At randomization and twice more at 12 week intervals ]
    Value measured in mmHg

  9. Diastolic blood pressure [ Time Frame: At randomization and twice more at 12 week intervals ]
    Value measured in mmHg


Other Outcome Measures:
  1. Time to castration resistance [ Time Frame: Followed yearly for up to 15 years from randomization ]
    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.

  2. Time to death [ Time Frame: Followed yearly for up to 15 years from randomization ]
    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.

  3. Time to prostate cancer death [ Time Frame: Followed yearly for up to 15 years from randomization ]
    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.

  4. Bone fractures [ Time Frame: Followed yearly for up to 15 years from randomization ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050397


Contacts
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Contact: Teemu Murtola, MD PhD +358 3 311 65015 teemu.murtola@tuni.fi
Contact: Teuvo Tammela, MD PhD +358 3 311 64621 teuvo.tammela@tuni.fi

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33520
Contact: Teemu Murtola, MD, PhD    +358 3 311 65015    teemu.murtola@tuni.fi   
Contact: Teuvo Tammela, MD PhD    +358 3 311 64621    teuvo.tammela@tuni.fi   
Sub-Investigator: Lauri Rantaniemi         
Sub-Investigator: Jarno Riikonen, MD PhD         
Sub-Investigator: Hanna Ojala, PhD         
Sub-Investigator: Ilkka Pietilä, PhD         
Sub-Investigator: Teuvo LJ Tammela, MD PhD         
Sponsors and Collaborators
Tampere University Hospital
Varalan urheiluopisto
Investigators
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Principal Investigator: Teemu Murtola, MD PhD Tampereen University, Faculty of Medicine and Health Technology
  Study Documents (Full-Text)

Documents provided by Tampere University Hospital:

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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT04050397     History of Changes
Other Study ID Numbers: Patient School 1
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared since it is prohibited by the ethics board and by patient consent

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tampere University Hospital:
androgen deprivation therapy
exercise
quality of life
blood glucose
cholesterol
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs