Ovary Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERHigh fat smoothie
Participants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein.
Sponsors
University of Tennessee Graduate School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women * Age \>18 * Presumed ovarian cancer diagnosis (i.e. those being clinically evaluated for suspicion of ovary cancer) * Planned treatment course for ovarian cancer involving cytoreductive surgery followed by chemotherapy * Availability to commit to attending all study visits * Internet access and consistent access to phone/email/text communication
Exclusion criteria
* Pregnancy * Inability to provide voluntary informed consent * Inability to consume the pre-study visit meal/snack and/or the study visit meal due to strict dietary restrictions * Illicit substance use (e.g. cocaine, methamphetamines, heroin, street drugs) - marijuana and CBD oil and related supplements will be considered on a case-by-case basis by the principal investigators * Circumstances and/or medical condition that would limit compliance with study requirements and protocol, as determined by the principal investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility assessed by attrition | 60 months | Feasibility assessed by ≤20% attrition (yes/no), defined as the percentage of enrolled participants, that are able to complete all three study visits. |
| Feasibility and acceptability assessed by protocol adherence | 60 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting carbon dioxide production | Immediately at the beginning of the study visit | Fasting carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry. |
| Fasting oxygen consumption | Immediately at the beginning of the study visit | Fasting oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry. |
| Fasting capillary blood glucose | Immediately at the beginning of the study visit | Fasting capillary blood glucose (mg/dL) |
| Fasting capillary blood lactate | Immediately at the beginning of the study visit | Fasting capillary blood lactate (mmol/L) |
| 1 hour resting energy expenditure | Assessed at 1 hour post- high-fat smoothie consumption | 1 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry. |
| 1 hour respiratory quotient (RQ) | Assessed at 1 hour post- high-fat smoothie consumption | 1 hour respiratory quotient (RQ) assessed using indirect calorimetry |
| 1 hour carbon dioxide production | Assessed at 1 hour post- high-fat smoothie consumption | 1 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry. |
| 1 hour oxygen consumption | Assessed at 1 hour post- high-fat smoothie consumption | 1 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry. |
| 1 hour capillary blood glucose | Assessed at 1 hour post- high-fat smoothie consumption | 1 hour capillary blood glucose (mg/dL) |
| 1 hour capillary blood lactate | Assessed at 1 hour post- high-fat smoothie consumption | 1 hour capillary blood lactate (mmol/L) |
| 2 hour resting energy expenditure | Assessed at 2 hours post- high-fat smoothie consumption | 2 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry. |
| Fasting resting energy expenditure | Immediately at the beginning of the study visit | Fasting resting energy expenditure (Kcal/D) assessed using indirect calorimetry. |
| 2 hour carbon dioxide production | Assessed at 2 hours post- high-fat smoothie consumption | 2 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry. |
| 2 hour oxygen consumption | Assessed at 2 hours post- high-fat smoothie consumption | 2 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry. |
| 2 hour capillary blood glucose | Assessed at 2 hours post- high-fat smoothie consumption | 2 hour capillary blood glucose (mg/dL) |
| 2 hour capillary blood lactate | Assessed at 2 hours post- high-fat smoothie consumption | 2 hour capillary blood lactate (mmol/L) |
| 3 hour resting energy expenditure | Assessed at 3 hours post- high-fat smoothie consumption | 3 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry. |
| 3 hour respiratory quotient (RQ) | Assessed at 3 hours post- high-fat smoothie consumption | 3 hour respiratory quotient (RQ) assessed using indirect calorimetry |
| 3 hour carbon dioxide production | Assessed at 3 hours post- high-fat smoothie consumption | 3 hour carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry. |
| 3 hour oxygen consumption | Assessed at 3 hours post- high-fat smoothie consumption | 3 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry. |
| 3 hour capillary blood glucose | Assessed at 3 hours post- high-fat smoothie consumption | 3 hour capillary blood glucose (mg/dL) |
| 3 hour capillary blood lactate | Assessed at 3 hours post- high-fat smoothie consumption | 3 hour capillary blood lactate (mmol/L) |
| 2 hour respiratory quotient (RQ) | Assessed at 2 hour post- high-fat smoothie consumption | 2 hour respiratory quotient (RQ) assessed using indirect calorimetry |
| Fasting respiratory quotient (RQ) | Immediately at the beginning of the study visit | Fasting respiratory quotient (RQ) assessed using indirect calorimetry |
Countries
United States
Contacts
Primary ContactJill M Maples, PhD
Outcome results
None listed