Ovary CancerNCT06800105
Dysregulation of Whole-body Metabolism in Ovarian Cancer: A Longitudinal Study
An observational study of Ovary Cancer, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- High fat smoothie
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients being treated clinically for gynecologic malignancy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
Jill M Maples, PhD, jmaples1@utmck.edu
About this study
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.
Read the 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.
- Conditions
- Ovary Cancer
- Being tested
- High fat smoothie
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat smoothieOther
Participants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein.
| Study group | Role | What they receive |
|---|---|---|
| Patients with presumed ovarian cancer | Patients with presumed ovarian cancer will complete three, 4-hour study visits at the following time points:
* The 1st visit will occur before treatment.
* The 2nd visit will occur after about half of the planned treatment as been completed.
* The 3rd visit will occur 4-8 weeks after the completion of treatment. Receives: Other: High fat smoothie |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 60 months
Secondary outcomes (24)
Fasting resting energy expenditure
Fasting resting energy expenditure (Kcal/D) assessed using indirect calorimetry.
Measured: Immediately at the beginning of the study visit
Fasting respiratory quotient (RQ)
Fasting respiratory quotient (RQ) assessed using indirect calorimetry
Measured: Immediately at the beginning of the study visit
Fasting carbon dioxide production
Fasting carbon dioxide production (VCO2) (ml/min) assessed using indirect calorimetry.
Measured: Immediately at the beginning of the study visit
Fasting oxygen consumption
Fasting oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.
Measured: Immediately at the beginning of the study visit
Fasting capillary blood glucose
Fasting capillary blood glucose (mg/dL)
Measured: Immediately at the beginning of the study visit
Fasting capillary blood lactate
Fasting capillary blood lactate (mmol/L)
Measured: Immediately at the beginning of the study visit
1 hour resting energy expenditure
1 hour resting energy expenditure (Kcal/D) assessed using indirect calorimetry.
Measured: Assessed at 1 hour post- high-fat smoothie consumption
1 hour respiratory quotient (RQ)
1 hour respiratory quotient (RQ) assessed using indirect calorimetry
Measured: 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.
Measured: Assessed at 1 hour post- high-fat smoothie consumption
1 hour oxygen consumption
1 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.
Measured: Assessed at 1 hour post- high-fat smoothie consumption
1 hour capillary blood glucose
1 hour capillary blood glucose (mg/dL)
Measured: Assessed at 1 hour post- high-fat smoothie consumption
1 hour capillary blood lactate
1 hour capillary blood lactate (mmol/L)
Measured: 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.
Measured: Assessed at 2 hours post- high-fat smoothie consumption
2 hour respiratory quotient (RQ)
2 hour respiratory quotient (RQ) assessed using indirect calorimetry
Measured: 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.
Measured: Assessed at 2 hours post- high-fat smoothie consumption
2 hour oxygen consumption
2 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.
Measured: Assessed at 2 hours post- high-fat smoothie consumption
2 hour capillary blood glucose
2 hour capillary blood glucose (mg/dL)
Measured: Assessed at 2 hours post- high-fat smoothie consumption
2 hour capillary blood lactate
2 hour capillary blood lactate (mmol/L)
Measured: 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.
Measured: Assessed at 3 hours post- high-fat smoothie consumption
3 hour respiratory quotient (RQ)
3 hour respiratory quotient (RQ) assessed using indirect calorimetry
Measured: 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.
Measured: Assessed at 3 hours post- high-fat smoothie consumption
3 hour oxygen consumption
3 hour oxygen consumption (VO2)(ml/min) assessed using indirect calorimetry.
Measured: Assessed at 3 hours post- high-fat smoothie consumption
3 hour capillary blood glucose
3 hour capillary blood glucose (mg/dL)
Measured: Assessed at 3 hours post- high-fat smoothie consumption
3 hour capillary blood lactate
3 hour capillary blood lactate (mmol/L)
Measured: Assessed at 3 hours post- high-fat smoothie consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start22 Mar 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800105
- Sponsor's protocol ID
- 5023
- Status last verified
- Jan 2025
- First submitted
- 30 Oct 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Datasets will not be publicly available but can be shared by request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysregulation of Whole-body Metabolism in Ovarian Cancer: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT06800105
- Acronym / sponsor ID
- 5023
- Conditions
- Ovary Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with presumed ovarian cancer | – | Other: High fat smoothiePatients with presumed ovarian cancer will complete three, 4-hour study visits at the following time points: * The 1st visit will occur before treatment. * The 2nd visit will occur after about half of the planned treatment as been completed. * The 3rd visit will occur 4-8 weeks after the completion of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated clinically for gynecologic malignancy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High fat smoothieParticipants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein. | Other | Patients with presumed ovarian cancer |
Primary outcome
Feasibility assessed by attrition
Time frame: 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
Time frame: 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
24 secondary outcomes
Fasting resting energy expenditure
Time frame: Immediately at the beginning of the study visit
Fasting respiratory quotient (RQ)
Time frame: Immediately at the beginning of the study visit
Fasting carbon dioxide production
Time frame: Immediately at the beginning of the study visit
Fasting oxygen consumption
Time frame: Immediately at the beginning of the study visit
Fasting capillary blood glucose
Time frame: Immediately at the beginning of the study visit
Fasting capillary blood lactate
Time frame: Immediately at the beginning of the study visit
1 hour resting energy expenditure
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour respiratory quotient (RQ)
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour carbon dioxide production
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour oxygen consumption
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour capillary blood glucose
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
1 hour capillary blood lactate
Time frame: Assessed at 1 hour post- high-fat smoothie consumption
2 hour resting energy expenditure
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
2 hour respiratory quotient (RQ)
Time frame: Assessed at 2 hour post- high-fat smoothie consumption
2 hour carbon dioxide production
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
2 hour oxygen consumption
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
2 hour capillary blood glucose
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
2 hour capillary blood lactate
Time frame: Assessed at 2 hours post- high-fat smoothie consumption
3 hour resting energy expenditure
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour respiratory quotient (RQ)
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour carbon dioxide production
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour oxygen consumption
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour capillary blood glucose
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
3 hour capillary blood lactate
Time frame: Assessed at 3 hours post- high-fat smoothie consumption
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Undecided. Datasets will not be publicly available but can be shared by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovary Cancer, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill M Maples, PhD (8653059367, jmaples1@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by attrition (time frame: 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.