Clinical trial NCT05156424: A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
Official title: A Comparison of Aerobic and Resistance Exercise for Counteracting the Adverse Effects of Androgen Deprivation Therapy in Men With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Exercise
Prostate Cancer
Keywords: Prostate Cancer
Physical Fitness
Androgen Deprivation Therapy
Exercise
Cancer
Lead sponsor: Waterford Instituate of Technology
Sponsor class: OTHER
Collaborators: name: Irish Research Council
name: University of Pittsburgh Medical Center
name: Waterford Instituate of Technology
First posted: 2021-12-14
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomised control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prostate cancer is the second most common cancer in men. Those in the intermediate/high-risk categories typically receive androgen deprivation therapy (ADT) and radiotherapy. ADT greatly reduces androgen production as prostate cancer is dependent on testosterone and dihydrotestosterone for its growth.The side effects of ADT therapy are extensive and include changes in body composition (muscle loss, bone loss and fat gain), strength, mood, physical function, sexual function and increased cardiovascular risk and fatigue. Many of these side effects can be influenced by exercise training, both resistance training and aerobic training. However, the most appropriate exercise regime for men undergoing ADT has received little research attention.

Detailed description: Although many interventions for prostate survivors emphasise resistance exercise to maintain muscle mass and strength. Arguments could equally be made for programmes emphasising aerobic exercise for fatigue, anxiety, cardiovascular risk reduction and indeed overall survival.

Comparisons of programmes that emphasise each exercise mode are clearly required.

Therefore the overall purpose of this feasibility and pilot randomised control trial is to determine the feasibility and preliminary effectiveness of an aerobic emphasised exercise program (AE) verses a resistance emphasise exercise program (RE) in a rehabilitation setting, over 6 months, for prostate cancer men undergoing Androgen Deprivation Therapy (ADT).

Eligibility criteria: Inclusion Criteria:

* \>18 years of age with a histologically diagnosed prostate cancer
* Prescribed ADT (Androgen deprivation Therapy)
* Self-reported not to be partaking in regular exercise (structured aerobic or resistance training ≥ 2 sessions/week) in the past 3 months.
* Medically cleared to exercise by their oncologist

Exclusion Criteria:

* Prior exposure to ADT \>12 months
* Prior hypogonadism
* Established metastatic bone disease
* Established Osteoporosis
* Musculoskeletal/Cardiovascular and/or Neurological disease that could put them at risk from exercise as judged by the attending physician.

Primary outcomes:
measure: Feasibility- recruitment rate (%)
timeFrame: At study conclusion
measure: Feasibility- retention rate (%)
timeFrame: Intervention conclusion 24 weeks
measure: Feasibility- exercise program adherence through attendance %.
timeFrame: Throughout 24 week intervention
measure: Feasibility- exercise prescription adherence (% of modified sessions compared to attended exercise sessions)
timeFrame: Throughout 24 week intervention
measure: Feasibility- Adverse Event using CTCAE v4.0 grading system.
timeFrame: At study conclusion
measure: Feasibility- Patient satisfaction/acceptability through qualitative evaluation.
timeFrame: Following intervention conclusion at 24 weeks
Secondary outcomes:
measure: General quality of life by questionnaire
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Cancer Specific quality of life by questionnaire
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Prostate cancer specific quality of life by questionnaire
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Fatigue by questionnaire
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Physical Activity (subjective) by questionnaire
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Anthropometric assessment.
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Waist and Hip circumference analysis (cms)
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Body composition (fat mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Body composition (fat and lean mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Bone density (BMD) measurement
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Visceral fat area (VAT Area) in cm(squared)
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Atrial stiffness measured by a Pulse Wave Velocity Assessment (m/s)
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Blood pressure (mmHg)
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Cardiovascular Fitness
timeFrame: 0(baseline), 8 weeks and 6 months (end of intervention)
measure: Peak torque/power for knee extension and flexion
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Lower limb strength [Leg Press]
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Upper limb strength [Chest Press]
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Functional Ability Assessment (Timed up and go)
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Functional Ability Assessment (Sit to stand)
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Functional Ability Assessment (Grip test)
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Functional Ability Assessment (Bess Balance test)
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Functional Ability Assessment (6 minute walk test)
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Functional Ability Assessment (Sit and reach)
timeFrame: At baseline, 8 weeks and 24 weeks (end of intervention)
measure: Biomarker Analysis: Blood lipids (mmol/L)
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Biomarker Analysis: Glucose (mmol/L)
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Biomarker Analysis: Insulin (mIU/L)
timeFrame: At baseline and 24 weeks (end of intervention)
measure: Biomarker Analysis: C-Reactive Protein (CRP)
timeFrame: At baseline and 24 weeks (end of intervention)
Other outcomes:
Locations:
city: Waterford
country: Ireland
facility: WIT Sports Arena
state: Munster
Study officials:
affiliation: Waterford Institute of Technology
name: Michael Dr Harrison, PhD
role: PRINCIPAL_INVESTIGATOR
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