About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients being treated clinically for gynecologic malignancy
Trial design
Cohort
Prospective
Treatments tested in this trial
High fat smoothie
Other interventionParticipants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein.
Treatment groups
Trial outcomes
Primary outcomes
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.
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
Secondary outcomes
Fasting resting energy expenditure
Fasting resting energy expenditure (Kcal/D) assessed using indirect calorimetry.
Fasting respiratory quotient (RQ)
Fasting respiratory quotient (RQ) assessed using indirect calorimetry
Fasting carbon dioxide production
Fasting carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.
Fasting oxygen consumption
Fasting oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.
Sponsors and contacts
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