Whole Body Metabolic Activity as a Reflection of Tumor Metabolic Dysregulation and a Predictor of Treatment Response in Ovarian Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in oxygen consumption
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%
Arms & Interventions
Ovarian Cancer Cohort
Patients with ovarian cancer undergoing standard-of-care treatment who will undergo serial whole-body metabolic assessments, biospecimen collection, and clinical follow-up to evaluate the relationship between systemic metabolic activity, tumor metabolic characteristics, and treatment outcomes.
Outcomes
Primary Outcomes
Change in oxygen consumption
Time Frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in metabolic flexibility
Time Frame: prior to the treatment [SV1] and six months after completion of chemotherapy [SV7]
Change in resting metabolic rate
Time Frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in respiratory quotient
Time Frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in carbon dioxide production
Time Frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Secondary Outcomes
No secondary outcomes reported