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

NCT06800105 | Recruiting

• 1 other identifier: 5023
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovary Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (24)

• Fasting resting energy expenditure

  Immediately at the beginning of the study visit

• Fasting respiratory quotient (RQ)

  Immediately at the beginning of the study visit

• Fasting carbon dioxide production

  Immediately at the beginning of the study visit

• Fasting oxygen consumption

  Immediately at the beginning of the study visit

• Fasting capillary blood glucose

  Immediately at the beginning of the study visit

Study Arms (1)

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

Interventions

High fat smoothie OTHER

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

Patients with presumed ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Being clinically treated for gynecologic malignancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being treated clinically for gynecologic malignancy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Jill M Maples, PhD

CONTACT

8653059367; jmaples1@utmck.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: January 29, 2025
• Study Start: March 22, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (1)