Whole Body Metabolic Activity as a Reflection of Tumor Metabolic Dysregulation and a Predictor of Treatment Response in Ovarian Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Tennessee Graduate School of Medicine

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Ovarian Cancer Cohort

Trial outcomes

Primary outcomes

1

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]
2

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]
3

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]
4

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]

Secondary outcomes

Other outcomes

Sponsors and contacts

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