Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06800105

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

Location status: Recruiting

Location contact

Jill M Maples, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High fat smoothie

Other

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

Primary outcomes

  1. Feasibility assessed by attrition

    Time frame: 60 months

    Feasibility assessed by ≤20% attrition (yes/no), defined as the percentage of enrolled participants, that are able to complete all three study visits.

  2. Feasibility and acceptability assessed by protocol adherence

    Time frame: 60 months

    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

Secondary outcomes

  1. Fasting resting energy expenditure

    Time frame: Immediately at the beginning of the study visit

    Fasting resting energy expenditure (Kcal/D) assessed using indirect calorimetry.

  2. Fasting respiratory quotient (RQ)

    Time frame: Immediately at the beginning of the study visit

    Fasting respiratory quotient (RQ) assessed using indirect calorimetry

  3. Fasting carbon dioxide production

    Time frame: Immediately at the beginning of the study visit

    Fasting carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.

  4. Fasting oxygen consumption

    Time frame: Immediately at the beginning of the study visit

    Fasting oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.

  5. Fasting capillary blood glucose

    Time frame: Immediately at the beginning of the study visit

    Fasting capillary blood glucose (mg/dL)

  6. Fasting capillary blood lactate

    Time frame: Immediately at the beginning of the study visit

    Fasting capillary blood lactate (mmol/L)

  7. 1 hour resting energy expenditure

    Time frame: Assessed at 1 hour post- high-fat smoothie consumption

    1 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry.

  8. 1 hour respiratory quotient (RQ)

    Time frame: Assessed at 1 hour post- high-fat smoothie consumption

    1 hour respiratory quotient (RQ) assessed using indirect calorimetry

  9. 1 hour carbon dioxide production

    Time frame: Assessed at 1 hour post- high-fat smoothie consumption

    1 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.

  10. 1 hour oxygen consumption

    Time frame: Assessed at 1 hour post- high-fat smoothie consumption

    1 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.

  11. 1 hour capillary blood glucose

    Time frame: Assessed at 1 hour post- high-fat smoothie consumption

    1 hour capillary blood glucose (mg/dL)

  12. 1 hour capillary blood lactate

    Time frame: Assessed at 1 hour post- high-fat smoothie consumption

    1 hour capillary blood lactate (mmol/L)

  13. 2 hour resting energy expenditure

    Time frame: Assessed at 2 hours post- high-fat smoothie consumption

    2 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry.

  14. 2 hour respiratory quotient (RQ)

    Time frame: Assessed at 2 hour post- high-fat smoothie consumption

    2 hour respiratory quotient (RQ) assessed using indirect calorimetry

  15. 2 hour carbon dioxide production

    Time frame: Assessed at 2 hours post- high-fat smoothie consumption

    2 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.

  16. 2 hour oxygen consumption

    Time frame: Assessed at 2 hours post- high-fat smoothie consumption

    2 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.

  17. 2 hour capillary blood glucose

    Time frame: Assessed at 2 hours post- high-fat smoothie consumption

    2 hour capillary blood glucose (mg/dL)

  18. 2 hour capillary blood lactate

    Time frame: Assessed at 2 hours post- high-fat smoothie consumption

    2 hour capillary blood lactate (mmol/L)

  19. 3 hour resting energy expenditure

    Time frame: Assessed at 3 hours post- high-fat smoothie consumption

    3 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry.

  20. 3 hour respiratory quotient (RQ)

    Time frame: Assessed at 3 hours post- high-fat smoothie consumption

    3 hour respiratory quotient (RQ) assessed using indirect calorimetry

  21. 3 hour carbon dioxide production

    Time frame: Assessed at 3 hours post- high-fat smoothie consumption

    3 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.

  22. 3 hour oxygen consumption

    Time frame: Assessed at 3 hours post- high-fat smoothie consumption

    3 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.

  23. 3 hour capillary blood glucose

    Time frame: Assessed at 3 hours post- high-fat smoothie consumption

    3 hour capillary blood glucose (mg/dL)

  24. 3 hour capillary blood lactate

    Time frame: Assessed at 3 hours post- high-fat smoothie consumption

    3 hour capillary blood lactate (mmol/L)

Study contacts

Contact information is provided by the study sponsor or research team.

Jill M Maples, PhD

CONTACT

[email protected]

8653059367

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.