Assessing Whole-body Metabolism in Gynecologic Cancers in Response to a Single Chemotherapy Cycle and/ or Immunotherapy

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 Overview

• Status: Completed
• Conditions: Gynecologic Cancers

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with gynecologic cancer engaged in active treatment.

Description

Inclusion Criteria:

• Women
• Age >18 years
• Biopsy confirmed gynecologic cancer.
• Scheduled to or currently undergoing infusion therapy.
• Receiving cytotoxic chemotherapy or immunotherapy.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with biopsy proven gynecologic cancer; Patients with biopsy proven gynecologic cancer undergoing active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	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.	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	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.	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.	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.	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	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.	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.	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.	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	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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting capillary blood glucose	Fasting capillary blood glucose (mg/dL)	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)	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)	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)	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)	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)	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)	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)	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)	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)	Fasting, measured at the start of the study visit at one time point during active cancer treatment.

Collaborators and Investigators

• Sponsor: University of Tennessee Graduate School of Medicine
• Collaborators: University of Tennessee Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): January 24, 2026

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: lipid metabolism; ovarian cancer; gynecologic cancer; oxygen consumption; uterine cancer; resting metabolic rate; cardiometabolic outcomes; whole body metabolism; carbon dioxide production
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Uterine Neoplasms
• Other Study ID Numbers: 5204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Datasets will not be publicly available but can be shared by request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No