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

NCT07393633 | Completed

• 1 other identifier: 5204
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (10)

• Fasting capillary blood glucose

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

• Fasting capillary blood lactate

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

• Fasting venous blood glucose

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

• Fasting venous blood insulin

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

• Fasting venous blood lactate

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

Study Arms (1)

Patients with biopsy proven gynecologic cancer

Patients with biopsy proven gynecologic cancer undergoing active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gynecologic cancer engaged in active treatment.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead
• University of Tennessee Medical Center: collaborator

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: August 1, 2024
• Primary Completion: April 4, 2025
• Study Completion: January 24, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)