Recruiting

Metabolic Alterations

Sponsor:

University of Tennessee Graduate School of Medicine

Code:

NCT07764133

Conditions

Epithelial Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The primary objectives of the study are:

1. To delineate commonly utilized tumor metabolic alterations in ovarian cancer. These metabolic alterations will be explored for potentially targetable pathways to restore chemotherapy responsiveness.
2. To define the relationship between whole-body metabolic activity as measured via indirect calorimetry with ex vivo measure of tumor metabolic activity.

The secondary objectives of the study are:
3. To evaluate longitudinal changes in whole-body metabolic activity over the course of cytotoxic chemotherapy and evaluate these changes as they relate to oncologic outcomes and treatment-free interval.
4. To examine the impact of tumor metabolic alterations on healthy non-malignant tissues and serum metabolites.
5. An additional exploratory objective is to collect data that will contribute to a more holistic understanding of the whole-body metabolic effects of ovarian cancer. Based on prior studies, surveys have been an effective method for capturing the social, psychological, and behavioral factors associated with the disease. It is possible that changes in metabolism and inflammation are mediated by these psychosocial factors that ultimately impact response to cancer therapy.

It is hypothesized that whole-body metabolic activity as measured via indirect calorimetry can be utilized as a non-invasive surrogate to reflect tumor metabolic dysregulation in patients with ovarian cancer. Moreover, it is hypothesized that there will be an inverse relationship between treatment-free interval and the metabolic rate when measured at a whole-body level and an increased rate of glycolysis when measured within the tumor microenvironment. To address these hypotheses, the study will pursue the specific aims listed above.

Conditions

Epithelial Ovarian Cancer

Study ID

NCT07764133

Start date

May 13, 2026

Status verified date

Jul, 2026

Completion date

May 13, 2028

Anticipated

Primary completion date

May 13, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Women
2. Age >18 years
3. Suspected of having epithelial ovarian cancer by the provider
4. No prior cytotoxic therapy for ovarian cancer
5. Surgical debulking is planned
6. ECOG performance status 0-1

Exclusion Criteria:

1. Inability to provide voluntary informed consent
2. Received medical intervention for adverse effects of chemotherapy
3. Circumstances and/or medical conditions that would limit compliance with study requirements and protocol, as determined by the principal investigators.
4. Poorly controlled diabetes, hemoglobin A1C ≥9%

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Ovarian Cancer Cohort

Patients with ovarian cancer undergoing standard-of-care treatment who will undergo serial whole-body metabolic assessments, biospecimen collection, and clinical follow-up to evaluate the relationship between systemic metabolic activity, tumor metabolic characteristics, and treatment outcomes.

Primary outcome measure

  • Change in resting metabolic rate [ Time Frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7] ]
  • Change in respiratory quotient [ Time Frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7] ]
  • Change in carbon dioxide production [ Time Frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7] ]
  • Change in oxygen consumption [ Time Frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7] ]
  • Change in metabolic flexibility [ Time Frame: prior to the treatment [SV1] and six months after completion of chemotherapy [SV7] ]

Central Contacts and Locations

Locations

University of Tennessee Medical Center - Knoxville

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Lina Reyes Fontalvo Research Coordinator

865-305-9987LFontalvo@utmck.edu

More Information

Sponsor

University of Tennessee Graduate School of Medicine

Last update posted

Aug 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Graduate School of Medicine on 2026-08-17.