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

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
University of Tennessee Graduate School of Medicine
Study ID
NCT07764133
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 13, 2026
Start date
May 13, 2026
Status verified
Jul 2026
Primary completion
May 13, 2028
Completion
May 13, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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] ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Tennessee Medical Center - KnoxvilleKnoxvilleTennessee37920
Lina Reyes Fontalvo Research Coordinator
[email protected]
865-305-9987

Find similar trials in Knoxville, TN

Nationwide
Ovarian cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials
By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Tennessee Medical Center - Knoxville· Knoxville, TN

Related Studies