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Minimal information is available regarding changes in whole-body metabolism in ovarian cancer patients, and no study has assessed whole-body lipid metabolism in this patient population. In this pilot study we will assess fasting and postprandial lipid metabolism of ovarian cancer patients before, during, and after treatment via indirect calorimetry.
Ovarian cancer is one of the deadliest gynecological diseases, with a 5-year survival rate of only 49%. It is well established that cancer cells have fundamentally altered metabolism, which contributes to proliferation and metastasis. Recent findings in the field have recognized that lipid metabolism is altered in ovarian cancer cells, with cells utilizing lipids as a primary energy source. Due to the high demand of energy from tumor cells, it's possible that other non-malignant tissues could reprogram their metabolism to create an environment that supports tumor growth. Minimal information is available regarding changes in whole-body metabolism in ovarian cancer patients, and no study has assessed whole-body lipid metabolism in this patient population. In this pilot study we will assess fasting and postprandial lipid metabolism of ovarian cancer patients before, during, and after treatment via indirect calorimetry. Markers of metabolism (e.g. glucose, blood lipids, lactate) will be assessed at each timepoint. This is a clinically significant project as understanding the full scope of dysregulated lipid metabolism in ovarian cancer patients will allow the identification of potential targets for treatment. The primary purpose is to assess feasibility and acceptability of this study protocol designed to collect pilot data and assess the metabolic profile and lipid metabolism of patients with presumed ovarian cancer. The secondary purpose of this project is to collect pilot data and assess the metabolic profile and lipid metabolism of patients with presumed ovarian cancer. A tertiary goal of this project is to collect additional pilot data to better understand the potential link between metabolic health and other factors related to metabolic health among patients with ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with presumed ovarian cancer | Patients with presumed ovarian cancer will complete three, 4-hour study visits at the following time points:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High fat smoothie | Other | Participants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility assessed by attrition | Feasibility assessed by ≤20% attrition (yes/no), defined as the percentage of enrolled participants, that are able to complete all three study visits. | 60 months |
| Feasibility and acceptability assessed by protocol adherence | Feasibility and acceptability assessed by ≥75% protocol adherence (yes/no) specifically measured by: Ability of the participant to consume pre-study visit meal Ability of the participant to consume study visit smoothie in 5 minutes Ability of the participant to complete the 4 metabolic assessments during the study visit Ability of the participant to complete surveys during the study visit Ability of the participant to arrive on time and leave at the planned time for the study visit Ability of the study team to coordinate delivery of the pre-study visit meal to participant | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting resting energy expenditure | Fasting resting energy expenditure (Kcal/D) assessed using indirect calorimetry. | Immediately at the beginning of the study visit |
| Fasting respiratory quotient (RQ) |
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Inclusion Criteria:
Exclusion Criteria:
Being clinically treated for gynecologic malignancy
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Patients being treated clinically for gynecologic malignancy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jill M Maples, PhD | Contact | 8653059367 | jmaples1@utmck.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Graduate School of Medicine | Recruiting | Knoxville | Tennessee | 37920 | United States |
Datasets will not be publicly available but can be shared by request.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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blood
Fasting respiratory quotient (RQ) assessed using indirect calorimetry
| Immediately at the beginning of the study visit |
| Fasting carbon dioxide production | Fasting carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry. | Immediately at the beginning of the study visit |
| Fasting oxygen consumption | Fasting oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry. | Immediately at the beginning of the study visit |
| Fasting capillary blood glucose | Fasting capillary blood glucose (mg/dL) | Immediately at the beginning of the study visit |
| Fasting capillary blood lactate | Fasting capillary blood lactate (mmol/L) | Immediately at the beginning of the study visit |
| 1 hour resting energy expenditure | 1 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry. | Assessed at 1 hour post- high-fat smoothie consumption |
| 1 hour respiratory quotient (RQ) | 1 hour respiratory quotient (RQ) assessed using indirect calorimetry | Assessed at 1 hour post- high-fat smoothie consumption |
| 1 hour carbon dioxide production | 1 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry. | Assessed at 1 hour post- high-fat smoothie consumption |
| 1 hour oxygen consumption | 1 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry. | Assessed at 1 hour post- high-fat smoothie consumption |
| 1 hour capillary blood glucose | 1 hour capillary blood glucose (mg/dL) | Assessed at 1 hour post- high-fat smoothie consumption |
| 1 hour capillary blood lactate | 1 hour capillary blood lactate (mmol/L) | Assessed at 1 hour post- high-fat smoothie consumption |
| 2 hour resting energy expenditure | 2 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry. | Assessed at 2 hours post- high-fat smoothie consumption |
| 2 hour respiratory quotient (RQ) | 2 hour respiratory quotient (RQ) assessed using indirect calorimetry | Assessed at 2 hour post- high-fat smoothie consumption |
| 2 hour carbon dioxide production | 2 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry. | Assessed at 2 hours post- high-fat smoothie consumption |
| 2 hour oxygen consumption | 2 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry. | Assessed at 2 hours post- high-fat smoothie consumption |
| 2 hour capillary blood glucose | 2 hour capillary blood glucose (mg/dL) | Assessed at 2 hours post- high-fat smoothie consumption |
| 2 hour capillary blood lactate | 2 hour capillary blood lactate (mmol/L) | Assessed at 2 hours post- high-fat smoothie consumption |
| 3 hour resting energy expenditure | 3 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry. | Assessed at 3 hours post- high-fat smoothie consumption |
| 3 hour respiratory quotient (RQ) | 3 hour respiratory quotient (RQ) assessed using indirect calorimetry | Assessed at 3 hours post- high-fat smoothie consumption |
| 3 hour carbon dioxide production | 3 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry. | Assessed at 3 hours post- high-fat smoothie consumption |
| 3 hour oxygen consumption | 3 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry. | Assessed at 3 hours post- high-fat smoothie consumption |
| 3 hour capillary blood glucose | 3 hour capillary blood glucose (mg/dL) | Assessed at 3 hours post- high-fat smoothie consumption |
| 3 hour capillary blood lactate | 3 hour capillary blood lactate (mmol/L) | Assessed at 3 hours post- high-fat smoothie consumption |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |