Overview
The primary objectives of the study are:
- To delineate commonly utilized tumor metabolic alterations in ovarian cancer. These metabolic alterations will be explored for potentially targetable pathways to restore chemotherapy responsiveness.
- 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.
Description
The dates of all study visits (seven in total) will be coordinated with each participant according to the anticipated chemotherapy schedule. If a participant enrolled in the study is found to have a non-gynecologic malignancy or benign pathology at the time of surgery, no further postoperative study visits will be completed.
There are a total of seven planned study visits.
Five study visits will include whole-body metabolic assessments:
- Prior to initiation of therapy or before surgical debulking (SV1).
- Four to six weeks after surgical debulking and before initiation of adjuvant chemotherapy (this timing is part of the standard of care) (SV3).
- Prior to cycle 3 of chemotherapy (SV4). This study visit will occur in conjunction with a scheduled chemotherapy visit.
- Prior to cycle 6 of chemotherapy (SV5). This study visit will occur in conjunction with a scheduled chemotherapy visit.
- Six months after completion of chemotherapy (SV7).
Two additional study visits (SV2 and SV6) will include vital sign and anthropometric assessments and blood collection.
- Blood samples will be collected for future ancillary testing, including circulating tumor DNA and serum metabolite analyses. Banked blood samples will be analyzed only after completion of study participation to minimize potential implications for clinical care, as circulating tumor DNA analysis remains experimental in ovarian cancer.
- Prior to surgical debulking (SV2). This study visit will be required only for participants who receive neoadjuvant chemotherapy before surgery. For participants who do not receive neoadjuvant chemotherapy, these assessments will be completed during SV1.
- Three months after completion of chemotherapy (SV6).
Direct participant involvement in the study ends after completion of the final study visit. The participant's electronic medical record (EMR) will be reviewed every six months until disease recurrence to collect oncologic outcome data, including progression-free survival and treatment-free interval.
Eligibility
Inclusion Criteria:
- Women
- Age \>18 years
- Suspected of having epithelial ovarian cancer by the provider
- No prior cytotoxic therapy for ovarian cancer
- Surgical debulking is planned
- ECOG performance status 0-1
Exclusion Criteria:
- 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%
