About this trial
The primary objectives of the study are:
1. To delineate commonly utilized tumor metabolic alterations in ovarian cancer. These metabolic alterations will be explored for potentially targetable pathways to restore chemotherapy responsiveness. 2. To define the relationship between whole-body metabolic activity as measured via indirect calorimetry with ex vivo measure of tumor metabolic activity.
The secondary objectives of the study are: 3. To evaluate longitudinal changes in whole-body metabolic activity over the course of cytotoxic chemotherapy and evaluate these changes as they relate to oncologic outcomes and treatment-free interval. 4. To examine the impact of tumor metabolic alterations on healthy non-malignant tissues and serum metabolites. 5. An additional exploratory objective is to collect data that will contribute to a more holistic understanding of the whole-body metabolic effects of ovarian cancer. Based on prior studies, surveys have been an effective method for capturing the social, psychological, and behavioral factors associated with the disease. It is possible that changes in metabolism and inflammation are mediated by these psychosocial factors that ultimately impact response to cancer therapy.
It is hypothesized that whole-body metabolic activity as measured via indirect calorimetry can be utilized as a non-invasive surrogate to reflect tumor metabolic dysregulation in patients with ovarian cancer. Moreover, it is hypothesized that there will be an inverse relationship between treatment-free interval and the metabolic rate when measured at a whole-body level and an increased rate of glycolysis when measured within the tumor microenvironment. To address these hypotheses, the study will pursue the specific aims listed above.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women
Age >18 years
Suspected of having epithelial ovarian cancer by the provider
No prior cytotoxic therapy for ovarian cancer
Disqualifiers
Inability to provide voluntary informed consent
Received medical intervention for adverse effects of chemotherapy
Circumstances and/or medical conditions that would limit compliance with study requirements and protocol, as determined by the principal investigators.
Poorly controlled diabetes, hemoglobin A1C ≥9%
Trial population
Patients with ovarian cancer receiving care at the study institution will be recruited for participation. Potential participants will be identified through their treating physicians and/or clinical care teams during routine clinical encounters, as well as through review of medical records for eligibility. The study population will include adults with ovarian cancer who are undergoing standard-of-care treatment, including surgery and/or chemotherapy, and who meet the study inclusion criteria. Participants will be followed prospectively to assess whole-body metabolic activity, tumor metabolic characteristics, and treatment-related outcomes. Efforts will be made to enroll a diverse group of participants representative of the patient population served by the institution.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in resting metabolic rate
Change in respiratory quotient
Change in carbon dioxide production
Change in oxygen consumption
Sponsors and contacts
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