Gynecologic CancersNCT07393633
Assessing Whole-body Metabolism in Gynecologic Cancers in Response to a Single Chemotherapy Cycle and/ or Immunotherapy
An observational study of Gynecologic Cancers, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
It is well established that cancer cells have fundamentally altered metabolism, which contributes to tumorigenicity and malignancy. For years, research findings supported that the universal property of all cancer cells was to increase glycolytic flux for anaerobic glycolysis (i.e., Warburg effect), which was accepted… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancers
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 24 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gynecologic cancer engaged in active treatment.
Who may be able to join
- Women
- Age >18 years
- Biopsy confirmed gynecologic cancer.
- Scheduled to or currently undergoing infusion therapy.
- Receiving cytotoxic chemotherapy or immunotherapy.
Who cannot join
- Inability to provide voluntary informed consent.
- Received inpatient medical intervention for adverse effects of chemotherapy.
- Circumstances and/or medical condition that would limit compliance with study requirements and protocol, as determined by the principal investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
About this study
It is well established that cancer cells have fundamentally altered metabolism, which contributes to tumorigenicity and malignancy. For years, research findings supported that the universal property of all cancer cells was to increase glycolytic flux for anaerobic glycolysis (i.e., Warburg effect), which was accepted as the dominant pathway for energy metabolism. Fortunately, by understanding these changes in cellular metabolism multiple new approaches to cancer therapy, focused on reprogramming the energy metabolism of the cell. Recently, further investigation in the field found that cancer cells exhibit multiple alterations in metabolic pathways, not only glycolysis.
Alterations in lipid metabolism in cancer cells have recently been recognized as potential targets for therapeutic interventions due to its role in cellular proliferation, energy storage, and the generation of signaling molecules. Numerous cancer types can rely on lipids as an energy source, increasing fatty acid synthesis and degradation to promote proliferation and metastasis. Several therapeutic agents utilized in gynecologic malignancies impact lipid metabolism.
The objective of the proposed study will be to determine the impact of cancer directed therapy on the lipid metabolism of non-malignant tissues. No study to date has assessed whole-body lipid metabolism in patients undergoing chemotherapy (i.e. cytotoxic chemotherapy and/or immunotherapy). These novel findings will provide crucial knowledge about the dysregulation of whole-body metabolism in patients receiving chemotherapy for treatment of gynecologic cancer.
- Conditions
- Gynecologic Cancers
- Keywords
- gynecologic cancer, whole body metabolism, lipid metabolism, ovarian cancer, cardiometabolic outcomes, uterine cancer, resting metabolic rate, oxygen consumption, carbon dioxide production
- Medical subject headings
- Ovarian Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with biopsy proven gynecologic cancer | Patients with biopsy proven gynecologic cancer undergoing active treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Whole Body Carbon Dioxide Production - Baseline
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting Whole Body Oxygen Consumption - Baseline
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting Resting Metabolic Rate (RMR) - Baseline
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER) - Baseline
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting Whole Body Carbon Dioxide Production - 30 Minutes Post
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Measured: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting Whole Body Oxygen Consumption - 30 Minutes Post
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Measured: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting Resting Metabolic Rate (RMR) - 30 Minutes Post
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Measured: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER) - 30 Minutes Post
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Measured: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting Whole Body Carbon Dioxide Production - 90 Minutes Post
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Measured: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting Whole Body Oxygen Consumption - 90 Minutes Post
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Measured: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting Resting Metabolic Rate (RMR) - 90 Minutes Post
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Measured: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER) - 90 Minutes Post
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Measured: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting Whole Body Carbon Dioxide Production - 150 Minutes Post
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Measured: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting Whole Body Oxygen Consumption - 150 Minutes Post
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Measured: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting Resting Metabolic Rate (RMR) - 150 Minutes Post
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Measured: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER) - 150 Minutes Post
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Measured: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Secondary outcomes (10)
Fasting capillary blood glucose
Fasting capillary blood glucose (mg/dL)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting capillary blood lactate
Fasting capillary blood lactate (mmol/L)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous blood glucose
Fasting venous plasma glucose (mg/dL)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous blood insulin
Fasting venous serum insulin (µlU/mL)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous blood lactate
Fasting venous plasma blood lactate (mmol/L)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous cholesterol (mg/dL)
Fasting venous cholesterol (mg/dL)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous HDL (mg/dL)
Fasting venous HDL (mg/dL)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous LDL (mg/dL)
Fasting venous LDL (mg/dL)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous VLDL (mg/dL)
Fasting venous VLDL (mg/dL)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous triglycerides (mg/dL)
Fasting venous triglycerides (mg/dL)
Measured: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Aug 2024
- Primary completion4 Apr 2025
- Study completion24 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393633
- Sponsor's protocol ID
- 5204
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets will not be publicly available but can be shared by request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Whole-body Metabolism in Gynecologic Cancers in Response to a Single Chemotherapy Cycle and/ or Immunotherapy
- ClinicalTrials.gov ID
- NCT07393633
- Acronym / sponsor ID
- 5204
- Conditions
- Gynecologic Cancers
- Keywords
- gynecologic cancer, whole body metabolism, lipid metabolism, ovarian cancer, cardiometabolic outcomes, uterine cancer, resting metabolic rate, oxygen consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Collaborators
- University of Tennessee Medical Center
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 24 Jan 2026 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well established that cancer cells have fundamentally altered metabolism, which contributes to tumorigenicity and malignancy. For years, research findings supported that the universal property of all cancer cells was to increase glycolytic flux for anaerobic glycolysis (i.e., Warburg effect), which was accepted as the dominant pathway for energy metabolism. Fortunately, by understanding these changes in cellular metabolism multiple new approaches to cancer therapy, focused on reprogramming the energy metabolism of the cell. Recently, further investigation in the field found that cancer cells exhibit multiple alterations in metabolic pathways, not only glycolysis.
Alterations in lipid metabolism in cancer cells have recently been recognized as potential targets for therapeutic interventions due to its role in cellular proliferation, energy storage, and the generation of signaling molecules. Numerous cancer types can rely on lipids as an energy source, increasing fatty acid synthesis and degradation to promote proliferation and metastasis. Several therapeutic agents utilized in gynecologic malignancies impact lipid metabolism.
The objective of the proposed study will be to determine the impact of cancer directed therapy on the lipid metabolism of non-malignant tissues. No study to date has assessed whole-body lipid metabolism in patients undergoing chemotherapy (i.e. cytotoxic chemotherapy and/or immunotherapy). These novel findings will provide crucial knowledge about the dysregulation of whole-body metabolism in patients receiving chemotherapy for treatment of gynecologic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with biopsy proven gynecologic cancer | – | –Patients with biopsy proven gynecologic cancer undergoing active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gynecologic cancer engaged in active treatment.
Key inclusion criteria (5 listed)
- Women
- Age >18 years
- Biopsy confirmed gynecologic cancer.
- Scheduled to or currently undergoing infusion therapy.
- Receiving cytotoxic chemotherapy or immunotherapy.
Key exclusion criteria (3 listed)
- Inability to provide voluntary informed consent.
- Received inpatient medical intervention for adverse effects of chemotherapy.
- Circumstances and/or medical condition that would limit compliance with study requirements and protocol, as determined by the principal investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fasting Whole Body Carbon Dioxide Production - Baseline
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Fasting Whole Body Oxygen Consumption - Baseline
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Fasting Resting Metabolic Rate (RMR) - Baseline
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Fasting respiratory exchange ratio (RER) - Baseline
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Fasting Whole Body Carbon Dioxide Production - 30 Minutes Post
Time frame: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Fasting Whole Body Oxygen Consumption - 30 Minutes Post
Time frame: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Fasting Resting Metabolic Rate (RMR) - 30 Minutes Post
Time frame: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Fasting respiratory exchange ratio (RER) - 30 Minutes Post
Time frame: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Fasting Whole Body Carbon Dioxide Production - 90 Minutes Post
Time frame: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Fasting Whole Body Oxygen Consumption - 90 Minutes Post
Time frame: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Fasting Resting Metabolic Rate (RMR) - 90 Minutes Post
Time frame: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Fasting respiratory exchange ratio (RER) - 90 Minutes Post
Time frame: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Fasting Whole Body Carbon Dioxide Production - 150 Minutes Post
Time frame: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Fasting Whole Body Oxygen Consumption - 150 Minutes Post
Time frame: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Fasting Resting Metabolic Rate (RMR) - 150 Minutes Post
Time frame: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Fasting respiratory exchange ratio (RER) - 150 Minutes Post
Time frame: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
10 secondary outcomes
Fasting capillary blood glucose
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting capillary blood lactate
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous blood glucose
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous blood insulin
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous blood lactate
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous cholesterol (mg/dL)
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous HDL (mg/dL)
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous LDL (mg/dL)
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous VLDL (mg/dL)
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting venous triglycerides (mg/dL)
Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes. Datasets will not be publicly available but can be shared by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancers, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Whole Body Carbon Dioxide Production - Baseline (time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.