Whole Body Metabolic Activity as a Reflection of Tumor Metabolic Dysregulation and a Predictor of Treatment Response in Ovarian Cancer

NCT07764133 | Recruiting

• 1 other identifier: 5542
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of the study are:

1. 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. 2.To define the relationship between whole-body metabolic activity as measured via indirect calorimetry with ex vivo measure of tumor metabolic activity.
3. 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. 4.To examine the impact of tumor metabolic alterations on healthy non-malignant tissues and serum metabolites.
5. 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.

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (5)

• Change in resting metabolic rate

  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

  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

  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

  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

  prior to the treatment [SV1] and six months after completion of chemotherapy [SV7]

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ovarian cancer receiving care at the study institution will be recruited for participation. Potential participants will be identified through their treating physicians and/or clinical care teams during routine clinical encounters, as well as through review of medical records for eligibility. The study population will include adults with ovarian cancer who are undergoing standard-of-care treatment, including surgery and/or chemotherapy, and who meet the study inclusion criteria. Participants will be followed prospectively to assess whole-body metabolic activity, tumor metabolic characteristics, and treatment-related outcomes. Efforts will be made to enroll a diverse group of participants representative of the patient population served by the institution.

You may qualify if:

• Women
• Age \>18 years
• Suspected of having epithelial ovarian cancer by the provider
• No prior cytotoxic therapy for ovarian cancer
• Surgical debulking is planned
• ECOG performance status 0-1

You may not qualify if:

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

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Medical Center - Knoxville

Knoxville, Tennessee, 37920, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; 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

Study Design

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

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 13, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): May 13, 2028
• Study Completion (Estimated): May 13, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-07

Locations

US (1)