Dysregulation of Whole-body Metabolism in Ovarian Cancer: A Longitudinal Study

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

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • High fat smoothie

    Other intervention

    Participants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Patients with presumed ovarian cancer1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
60 months
2

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

Time frame
60 months

Secondary outcomes

1

Fasting resting energy expenditure

Fasting resting energy expenditure (Kcal/D) assessed using indirect calorimetry.

Time frame
Immediately at the beginning of the study visit
2

Fasting respiratory quotient (RQ)

Fasting respiratory quotient (RQ) assessed using indirect calorimetry

Time frame
Immediately at the beginning of the study visit
3

Fasting carbon dioxide production

Fasting carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.

Time frame
Immediately at the beginning of the study visit
4

Fasting oxygen consumption

Fasting oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.

Time frame
Immediately at the beginning of the study visit

Other outcomes

Sponsors and contacts

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