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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovary Cancer
• Intervention / Treatment: Other: High fat smoothie

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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Jill M Maples, PhD; Phone Number: 8653059367; Email: jmaples1@utmck.edu

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Graduate School of Medicine
      • Contact: Jill M Maples, PhD; Email: jmaples1@utmck.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients being treated clinically for gynecologic malignancy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: High fat smoothie; Participants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting resting energy expenditure	Fasting resting energy expenditure (Kcal/D) assessed using indirect calorimetry.	Immediately at the beginning of the study visit
Fasting respiratory quotient (RQ)	Fasting respiratory quotient (RQ) assessed using indirect calorimetry	Immediately at the beginning of the study visit
Fasting carbon dioxide production	Fasting carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.	Immediately at the beginning of the study visit
Fasting oxygen consumption	Fasting oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.	Immediately at the beginning of the study visit
Fasting capillary blood glucose	Fasting capillary blood glucose (mg/dL)	Immediately at the beginning of the study visit
Fasting capillary blood lactate	Fasting capillary blood lactate (mmol/L)	Immediately at the beginning of the study visit
1 hour resting energy expenditure	1 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry.	Assessed at 1 hour post- high-fat smoothie consumption
1 hour respiratory quotient (RQ)	1 hour respiratory quotient (RQ) assessed using indirect calorimetry	Assessed at 1 hour post- high-fat smoothie consumption
1 hour carbon dioxide production	1 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.	Assessed at 1 hour post- high-fat smoothie consumption
1 hour oxygen consumption	1 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.	Assessed at 1 hour post- high-fat smoothie consumption
1 hour capillary blood glucose	1 hour capillary blood glucose (mg/dL)	Assessed at 1 hour post- high-fat smoothie consumption
1 hour capillary blood lactate	1 hour capillary blood lactate (mmol/L)	Assessed at 1 hour post- high-fat smoothie consumption
2 hour resting energy expenditure	2 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry.	Assessed at 2 hours post- high-fat smoothie consumption
2 hour respiratory quotient (RQ)	2 hour respiratory quotient (RQ) assessed using indirect calorimetry	Assessed at 2 hour post- high-fat smoothie consumption
2 hour carbon dioxide production	2 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.	Assessed at 2 hours post- high-fat smoothie consumption
2 hour oxygen consumption	2 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.	Assessed at 2 hours post- high-fat smoothie consumption
2 hour capillary blood glucose	2 hour capillary blood glucose (mg/dL)	Assessed at 2 hours post- high-fat smoothie consumption
2 hour capillary blood lactate	2 hour capillary blood lactate (mmol/L)	Assessed at 2 hours post- high-fat smoothie consumption
3 hour resting energy expenditure	3 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry.	Assessed at 3 hours post- high-fat smoothie consumption
3 hour respiratory quotient (RQ)	3 hour respiratory quotient (RQ) assessed using indirect calorimetry	Assessed at 3 hours post- high-fat smoothie consumption
3 hour carbon dioxide production	3 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.	Assessed at 3 hours post- high-fat smoothie consumption
3 hour oxygen consumption	3 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.	Assessed at 3 hours post- high-fat smoothie consumption
3 hour capillary blood glucose	3 hour capillary blood glucose (mg/dL)	Assessed at 3 hours post- high-fat smoothie consumption
3 hour capillary blood lactate	3 hour capillary blood lactate (mmol/L)	Assessed at 3 hours post- high-fat smoothie consumption

Collaborators and Investigators

• Sponsor: University of Tennessee Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms
• Other Study ID Numbers: 5023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Datasets will not be publicly available but can be shared by request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No