Clinical trial NCT06800105: Dysregulation of Whole-body Metabolism in Ovarian Cancer: A Longitudinal Study
Official title: Dysregulation of Whole-body Metabolism in Ovarian Cancer: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovary Cancer
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated clinically for gynecologic malignancy

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.

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

Primary outcomes:
measure: Feasibility assessed by attrition
timeFrame: 60 months
measure: Feasibility and acceptability assessed by protocol adherence
timeFrame: 60 months
Secondary outcomes:
measure: Fasting resting energy expenditure
timeFrame: Immediately at the beginning of the study visit
measure: Fasting respiratory quotient (RQ)
timeFrame: Immediately at the beginning of the study visit
measure: Fasting carbon dioxide production
timeFrame: Immediately at the beginning of the study visit
measure: Fasting oxygen consumption
timeFrame: Immediately at the beginning of the study visit
measure: Fasting capillary blood glucose
timeFrame: Immediately at the beginning of the study visit
measure: Fasting capillary blood lactate
timeFrame: Immediately at the beginning of the study visit
measure: 1 hour resting energy expenditure
timeFrame: Assessed at 1 hour post- high-fat smoothie consumption
measure: 1 hour respiratory quotient (RQ)
timeFrame: Assessed at 1 hour post- high-fat smoothie consumption
measure: 1 hour carbon dioxide production
timeFrame: Assessed at 1 hour post- high-fat smoothie consumption
measure: 1 hour oxygen consumption
timeFrame: Assessed at 1 hour post- high-fat smoothie consumption
measure: 1 hour capillary blood glucose
timeFrame: Assessed at 1 hour post- high-fat smoothie consumption
measure: 1 hour capillary blood lactate
timeFrame: Assessed at 1 hour post- high-fat smoothie consumption
measure: 2 hour resting energy expenditure
timeFrame: Assessed at 2 hours post- high-fat smoothie consumption
measure: 2 hour respiratory quotient (RQ)
timeFrame: Assessed at 2 hour post- high-fat smoothie consumption
measure: 2 hour carbon dioxide production
timeFrame: Assessed at 2 hours post- high-fat smoothie consumption
measure: 2 hour oxygen consumption
timeFrame: Assessed at 2 hours post- high-fat smoothie consumption
measure: 2 hour capillary blood glucose
timeFrame: Assessed at 2 hours post- high-fat smoothie consumption
measure: 2 hour capillary blood lactate
timeFrame: Assessed at 2 hours post- high-fat smoothie consumption
measure: 3 hour resting energy expenditure
timeFrame: Assessed at 3 hours post- high-fat smoothie consumption
measure: 3 hour respiratory quotient (RQ)
timeFrame: Assessed at 3 hours post- high-fat smoothie consumption
measure: 3 hour carbon dioxide production
timeFrame: Assessed at 3 hours post- high-fat smoothie consumption
measure: 3 hour oxygen consumption
timeFrame: Assessed at 3 hours post- high-fat smoothie consumption
measure: 3 hour capillary blood glucose
timeFrame: Assessed at 3 hours post- high-fat smoothie consumption
measure: 3 hour capillary blood lactate
timeFrame: Assessed at 3 hours post- high-fat smoothie consumption
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Graduate School of Medicine
state: Tennessee
Study officials:
References: