Clinical trial · Observational
Assessing Whole-body Metabolism in Gynecologic Cancers in Response to a Single Chemotherapy Cycle and/ or Immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancers | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with biopsy proven gynecologic cancer
- description
- Patients with biopsy proven gynecologic cancer undergoing active treatment
Primary outcomes (16)
- measure
- Fasting Whole Body Carbon Dioxide Production - Baseline
- timeFrame
- Fasting, measured at the start of the study visit at one time point during active cancer treatment.
- description
- Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
- measure
- Fasting Whole Body Oxygen Consumption - Baseline
- timeFrame
- Fasting, measured at the start of the study visit at one time point during active cancer treatment.
- description
- Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available