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NCT Number: NCT07393633

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.

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Key information

Conditions

Gynecologic Cancers Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. 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.

Secondary outcomes

  1. 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 glucose (mg/dL)

  2. Fasting capillary blood lactate

    Time frame: Fasting, measured at the start of the study visit at one time point during active cancer treatment.

    Fasting capillary blood lactate (mmol/L)

  3. 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 plasma glucose (mg/dL)

  4. 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 serum insulin (µlU/mL)

  5. 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 plasma blood lactate (mmol/L)

  6. 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 cholesterol (mg/dL)

  7. 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 HDL (mg/dL)

  8. 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 LDL (mg/dL)

  9. 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 VLDL (mg/dL)

  10. Fasting venous triglycerides (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)

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Collaborators

  • University of Tennessee Medical Center

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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