NCT06011499 · OHSU Knight Cancer Institute
Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE
(iLIVE)
What this study is about
This clinical trial tests the effectiveness of an online weight loss plus resistance training intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors.
View original scientific description
This clinical trial tests the effectiveness of an online weight loss plus resistance training intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and obesity can lead to a decrease in quality of life and an increased risk of recurrent falls. Using iLIVE may improve obesity and frailty in men with prostate cancer who receive ADT.
Interventions
OTHER
Internet-Based Exercise Intervention
Participate in online supervised, group resistance training sessions (iLIVE)
OTHER
Internet-Based Diet Intervention
Receive online access to an interactive website with a series of weekly self-directed and interactive sessions on various topics associated with diet and weight loss (iLIVE)
OTHER
Education Intervention
Receive usual care receiving educational information about diet and exercise for cancer survivors
Primary outcome measures
Change in overweight/obesity
Time frame: At baseline, 3 months, 6 months and 12 months
Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Overweight is defined as body mass index \> 25 kg/m\^2 and a 5% loss will be viewed as a successful outcome.
Change in sarcopenia
Time frame: At baseline and 6 months
Measured by 30 mg D3 creatine (D3Cr) capsule which they will ingest and then urinate on a test strip on the second void upon waking 3-6 days later. The enrichment of D3Cr will be measured from the test strip along with urine creatine and creatinine. Will use a cutoff of \< 10.75 kg/m\^2 (moderate sarcopenia).
Change in slowness
Time frame: At baseline, 3 months and 6 months
Measured by the fastest time of two 4m walks at a usual pace administered by study staff by remote teleconference. Will use a cut point for "slowness" in older men of speed \< 1.0 m/s - a clinically meaningful cutoff that predicts falls and loss of independence.
Change in weakness
Time frame: At baseline, 3 months, and 6 months
Measured by the seconds required to rise from a chair five times, administered by study staff by remote teleconference. Chair stand time \> 12 seconds predicts a 2.4 increased risk of falls in older adults and we will apply this cutoff for "weakness."
Change in inactivity
Time frame: At baseline, 3 months, 6 months, and 12 months
Measured by physical activity-related energy expenditure, calculated from self-report on the 41-item Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire. We will use \< 383 kcals per week spent in moderate-vigorous intensity activity as our low activity cut point. Measured also by Fitbit.
Change in fatigue
Time frame: At baseline, 3 months, 6 months, and 12 months
Measured using the 4-item short form (SF)-36 Vitality Scale. Will use cut points of scores of \< 50.00 (normed) for prostate cancer survivors (PCS) aged 50-64 years or scores less than 40.00 (normed) for PCS aged 65+ years.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- INTERVENTION PARTICIPANTS: Age 18 or older
- INTERVENTION PARTICIPANTS: Diagnosed with histologically confirmed prostate cancer
- INTERVENTION PARTICIPANTS: Received \>= 6 months of ADT any time in the past 10 years
- INTERVENTION PARTICIPANTS: Completed radiotherapy, chemotherapy and/or surgery \> 6 weeks prior to
- INTERVENTION PARTICIPANTS: No intent to start adjuvant chemotherapy or radiotherapy within 6 months of enrollment
- INTERVENTION PARTICIPANTS: Overweight or obese (body mass index \> 25 kg/m2 to BMI ≤ 50).
- INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or illness
- INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or resistance strength training exercise program
- INTERVENTION PARTICIPANTS: Willing to be randomized into either study arm and adhere to study protocol
- INTERVENTION PARTICIPANTS: Home internet sufficient for videoconferencing
- INTERVENTION PARTICIPANTS: Signed informed consent
- IMPLEMENTATION PARTICIPANTS: Be a key stakeholder (i.e., healthcare provider or administrative, or intervention participant \[completers, partial completers, or no participation\])
- IMPLEMENTATION PARTICIPANTS: Verbal informed consent following receipt of an information sheet
Exclusion criteria
- INTERVENTION PARTICIPANTS: Unintentional weight loss \> 5% within the last year
- INTERVENTION PARTICIPANTS: Contraindication to moderate intensity exercise
- INTERVENTION PARTICIPANTS: Health or medical condition that affects weight status/body composition (e.g., Cushing's syndrome, uncontrolled hyper-/hypo- thyroidism)
- INTERVENTION PARTICIPANTS: Active malignancy (other than non-melanoma skin cancer)
- INTERVENTION PARTICIPANTS: Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English
- INTERVENTION PARTICIPANTS: Currently taking or have taken creatine supplement in the month preceding baseline creatine testing
Where
- Portland, Oregon
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University, University of Alabama at Birmingham
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations