Dysregulation of Whole-body Metabolism in Ovarian Cancer: A Longitudinal Study

NCT ID: NCT06800105

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2028-03-31

Brief Summary

Minimal information is available regarding changes in whole-body metabolism in ovarian cancer patients, and no study has assessed whole-body lipid metabolism in this patient population. In this pilot study we will assess fasting and postprandial lipid metabolism of ovarian cancer patients before, during, and after treatment via indirect calorimetry.

Detailed Description

Ovarian cancer is one of the deadliest gynecological diseases, with a 5-year survival rate of only 49%. It is well established that cancer cells have fundamentally altered metabolism, which contributes to proliferation and metastasis. Recent findings in the field have recognized that lipid metabolism is altered in ovarian cancer cells, with cells utilizing lipids as a primary energy source. Due to the high demand of energy from tumor cells, it's possible that other non-malignant tissues could reprogram their metabolism to create an environment that supports tumor growth. Minimal information is available regarding changes in whole-body metabolism in ovarian cancer patients, and no study has assessed whole-body lipid metabolism in this patient population. In this pilot study we will assess fasting and postprandial lipid metabolism of ovarian cancer patients before, during, and after treatment via indirect calorimetry. Markers of metabolism (e.g. glucose, blood lipids, lactate) will be assessed at each timepoint. This is a clinically significant project as understanding the full scope of dysregulated lipid metabolism in ovarian cancer patients will allow the identification of potential targets for treatment. The primary purpose is to assess feasibility and acceptability of this study protocol designed to collect pilot data and assess the metabolic profile and lipid metabolism of patients with presumed ovarian cancer. The secondary purpose of this project is to collect pilot data and assess the metabolic profile and lipid metabolism of patients with presumed ovarian cancer. A tertiary goal of this project is to collect additional pilot data to better understand the potential link between metabolic health and other factors related to metabolic health among patients with ovarian cancer.

Conditions

Ovary Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with presumed ovarian cancer

Patients with presumed ovarian cancer will complete three, 4-hour study visits at the following time points:

• The 1st visit will occur before treatment.
• The 2nd visit will occur after about half of the planned treatment as been completed.
• The 3rd visit will occur 4-8 weeks after the completion of treatment.

High fat smoothie

Intervention Type: OTHER

Participants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein.

Interventions

High fat smoothie

Participants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women
• Age >18
• Presumed ovarian cancer diagnosis (i.e. those being clinically evaluated for suspicion of ovary cancer)
• Planned treatment course for ovarian cancer involving cytoreductive surgery followed by chemotherapy
• Availability to commit to attending all study visits
• Internet access and consistent access to phone/email/text communication

Exclusion Criteria

• Pregnancy
• Inability to provide voluntary informed consent
• Inability to consume the pre-study visit meal/snack and/or the study visit meal due to strict dietary restrictions
• Illicit substance use (e.g. cocaine, methamphetamines, heroin, street drugs) - marijuana and CBD oil and related supplements will be considered on a case-by-case basis by the principal investigators
• Circumstances and/or medical condition that would limit compliance with study requirements and protocol, as determined by the principal investigators

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jill M Maples, PhD

Role: CONTACT

jmaples1@utmck.edu

8653059367

Facility Contacts

Jill M Maples, PhD

Role: primary

jmaples1@utmck.edu

Other Identifiers

5023

Identifier Type: -

Identifier Source: org_study_id