Recruiting

iLIVE

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT06011499

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internet-Based Exercise Intervention

Internet-Based Diet Intervention

Education Intervention

Study Details

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.

Conditions

Prostate Carcinoma

Study ID

NCT06011499

Start date

Mar 12, 2024

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (iLIVE)

Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria smart scale while on study.

active comparator: Arm II (usual care)

Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.

Interventions

Internet-Based Exercise Intervention

Participate in online supervised, group resistance training sessions (iLIVE)

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)

Education Intervention

Receive usual care receiving educational information about diet and exercise for cancer survivors

Primary outcome measure

  • Change in overweight/obesity [ Time Frame: At baseline, 3 months, 6 months and 12 months ]
  • Change in sarcopenia [ Time Frame: At baseline and 6 months ]
  • Change in slowness [ Time Frame: At baseline, 3 months and 6 months ]
  • Change in weakness [ Time Frame: At baseline, 3 months, and 6 months ]
  • Change in inactivity [ Time Frame: At baseline, 3 months, 6 months, and 12 months ]
  • Change in fatigue [ Time Frame: At baseline, 3 months, 6 months, and 12 months ]

Central Contacts and Locations

Central contacts

Carolyn Guidarelli, MPH

503-346-0307borsch@ohsu.edu

Sharon McCoy, MS

503-494-1676mccoys@ohsu.edu

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Kerri Winters-Stone

503-494-0813wintersk@ohsu.edu

Principal Investigator:

Kerri Winters-Stone

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-05-08.