NCT06011499 Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE
| NCT ID | NCT06011499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-03-12 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Kerri Winters-Stone, PhD
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT06011499 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06011499 currently recruiting?
Yes, NCT06011499 is actively recruiting participants. Contact the research team at borsch@ohsu.edu for enrollment information.
Where is the NCT06011499 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT06011499 clinical trial?
NCT06011499 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Kerri Winters-Stone, PhD at OHSU Knight Cancer Institute. The trial plans to enroll 250 participants.