NCT07764133 · University of Tennessee Graduate School of Medicine
Whole Body Metabolic Activity as a Reflection of Tumor Metabolic Dysregulation and a Predictor of Treatment Response in Ovarian Cancer
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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]
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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%
Where
- Knoxville, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations