An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study

Launched by ROSWELL PARK CANCER INSTITUTE · Feb 27, 2025

Keywords

ClinConnect Summary

The "Life on the Go 3 Study" is a clinical trial designed to see how a personalized physical activity program, supported by wearable technology, can help improve the health and quality of life for patients with certain types of cancer, specifically stage II to IV ovarian, primary peritoneal, fallopian tube cancers, and newly diagnosed endometrial cancer. The study compares this new approach to the current standard of care, which recommends at least 150 minutes of moderate exercise each week. Researchers believe that increasing physical activity may boost not only physical fitness but also immune function and overall well-being, while also looking at how exercise affects gut health.

To participate, individuals must be at least 18 years old and have a specific type of cancer as mentioned. They should also be able to wear an activity tracker for most of their waking hours and have a smartphone with internet access. Throughout the 6-month study, participants will complete questionnaires and provide samples for research purposes. The trial is not yet recruiting, but it aims to gather important information about how physical activity can impact cancer treatment and recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old on day of signing informed consent
• • Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• * Participant must satisfy one of the following conditions:
• • Have a clinically suspected stage II-IV ovarian, primary peritoneal, or fallopian tube cancer by clinical presentation and elevated CA-125 and is awaiting staging surgery or tumor tissue biopsy followed by neoadjuvant chemotherapy. Inclusion of clinically suspected ovarian cancer cases is because we want to capture data starting from the earliest point of the diagnostic pathway and before definitive staging surgery. This allows us to assess the impact of physical activity and the feasibility of wearable device monitoring as patients transition into neoadjuvant chemotherapy and potential surgery
• • Have recurrent ovarian, primary peritoneal, or fallopian tube cancer at any time point of their recurrence, if they meet eligibility criteria (any histology accepted). Inclusion of recurrent ovarian cancer cases is because ovarian cancer often recurs, and understanding physical activity patterns and interventions in patients experiencing recurrence is critical for comprehensive insights. This ensures the study includes the continuum of disease management beyond initial diagnosis
• • Have pre-operative biopsy-proven endometrial cancer (endometrioid, serous, mucinous, or clear cell, poorly differentiated) with plans for surgical resection using a minimally invasive approach or medical management with chemotherapy combination, hormonal treatment or radiation. Inclusion of biopsy-proven endometrial cancer cases but not clinically suspected or recurrent cases is because we are focusing on confirmed, newly diagnosed patients who will undergo surgical resection or medical management
• • willing to wear the activity tracking device for at least 70% of their waking hours each day (11 hours/day) throughout the 6-month study period
• * under the care of Roswell Park Comprehensive Cancer Center during the study period, which includes one or more of the following:
• • Receiving cancer treatment at Roswell Park Comprehensive Cancer Center
• • Undergoing surgery at Roswell Park Comprehensive Cancer Center
• • Participating in surveillance visits at Roswell Park Comprehensive Cancer Center
• • Receiving adjuvant treatment at an outside facility but returning to Roswell Park Comprehensive Cancer Center for periodic consultation visits and agreeing to comply with all study procedures, including data sharing from external providers
• • willing to participate in questionnaires and blood and stool collection throughout the study for translational research purposes
• • Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
• • Have a smartphone with daily internet access that is compatible with the wearable devices and applications used in the study (e.g., Fitbit Sense 2 and CGM applications)
• • NOTE: Patients who are already achieving or exceeding the goal of 150 minutes of physical activity per week are eligible for this study. This inclusion is intentional, as the study aims to evaluate the full spectrum of physical activity levels-both baseline activity and changes over time-and their relationship with clinical outcomes, metabolic measures (e.g., glucose levels), inflammation, and physical function
• Exclusion Criteria:
• * serious psychiatric illness that is not currently stabilized, including but not limited to:
• • Schizophrenia or other psychotic disorders
• • Bipolar disorder
• • Sever major depressive disorder
• • Severe personality disorders diagnosed by a qualified mental health professional
• • Recent suicide attempt or psychiatric hospitalization within the previous 12 months
• • Life expectancy of less than 12 months, as determined by the Investigator based on clinical judgment and available prognostic tools
• * history of other invasive malignancies within the last two years, except for:
• • Non-melanoma skin cancer
• • In situ cervical cancer
• • resting heart rate greater than 120 beats per minute after 10 minutes of seated rest, confirmed on two separate measurements
• • systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg, measured after 10 minutes of seated rest, confirmed on two separate measurements
• • Unstable angina or myocardial infarction within the past 3 months.
• • Unstable Angina: Chest pain at rest or chest pain of increasing frequency, severity, or duration that requires medical attention
• • Myocardial Infarction: Heart attack diagnosed by a medical professional
• • Pregnant or nursing participants will be excluded, as confirmed via urine test during screening procedures.
• * unwilling or unable to follow the protocol requirements, including but not limited to:
• • Cognitive impairment that affects the ability to provide informed consent or comply with study procedures
• • Language barriers without access to adequate translation services
• • Lack of access to necessary technology (e.g., smartphones compatible with study devices)
• • Other factors that would prevent adherence to study protocols
• * Any condition which, in the Investigator's opinion, makes the patient unsuitable for participation in the study or may interfere with the patient's ability to comply with the study requirements or the safety of the patient. Conditions may include, but are not limited to:
• • Severe pulmonary disease
• • Uncontrolled metabolic disorders
• • Other significant medical conditions that pose a risk during increased physical activity
• • Participants who do not provide a valid cell phone number or do not consent to receive SMS messages from Fitabase for motivational and compliance monitoring purposes will be excluded from the study.