RecruitingObservational

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

NCT ID: NCT06800105Sponsor: University of Tennessee Graduate School of MedicineLast updated: 2025-01-29

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.

Arms & interventions

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

Outcome measures

Primary

Feasibility assessed by attrition
Feasibility assessed by ≤20% attrition (yes/no), defined as the percentage of enrolled participants, that are able to complete all three study visits.
Time frame: 60 months
Feasibility and acceptability assessed by protocol adherence
Feasibility and acceptability assessed by ≥75% protocol adherence (yes/no) specifically measured by: Ability of the participant to consume pre-study visit meal Ability of the participant to consume study visit smoothie in 5 minutes Ability of the participant to complete the 4 metabolic assessments during the study visit Ability of the participant to complete surveys during the study visit Ability of the participant to arrive on time and leave at the planned time for the study visit Ability of the study team to coordinate delivery of the pre-study visit meal to participant
Time frame: 60 months

Secondary

Fasting resting energy expenditure
Time frame: Immediately at the beginning of the study visit
Fasting respiratory quotient (RQ)
Time frame: Immediately at the beginning of the study visit
Fasting carbon dioxide production
Time frame: Immediately at the beginning of the study visit
Fasting oxygen consumption
Time frame: Immediately at the beginning of the study visit
Fasting capillary blood glucose
Time frame: Immediately at the beginning of the study visit
Fasting capillary blood lactate
Time frame: Immediately at the beginning of the study visit
1 hour resting energy expenditure
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour respiratory quotient (RQ)
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour carbon dioxide production
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour oxygen consumption
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour capillary blood glucose
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour capillary blood lactate
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
2 hour resting energy expenditure
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
2 hour respiratory quotient (RQ)
Time frame: Assessed at 2 hour post- high-fat smoothie consumption
2 hour carbon dioxide production
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
2 hour oxygen consumption
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
2 hour capillary blood glucose
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
2 hour capillary blood lactate
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
3 hour resting energy expenditure
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour respiratory quotient (RQ)
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour carbon dioxide production
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour oxygen consumption
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour capillary blood glucose
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour capillary blood lactate
Time frame: Assessed at 3 hours post- high-fat smoothie consumption

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920

Recruiting

Jill M Maples, PhD · Contact

jmaples1@utmck.edu