Gynecologycal CancerMITO-RESNCT07046936
Role of Mitochondrial Bioenergetics in Resilience for Gynecologic Cancer
An observational study of Gynecologycal Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The purpose of this research study is to see if patients with endometrial and ovarian cancer are willing to complete physical and cognitive assessments before treatment and again after treatment has ended. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Gynecologycal Cancer
- What is being tested?
- muscle sample and blood draw
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Mar 2026to Apr 2027
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a suspected or confirmed diagnosis of ovarian, primary peritoneal, fallopian tube, or endometrial cancer with planned standard of care treatment.
Who may be able to join
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age ≥50 years at the time of enrollment
- Newly diagnosed or suspected FIGO Stage II-IV ovarian/primary peritoneal/fallopian tube carcinoma of any histological subtype OR FIGO Stage II-IV endometrial carcinoma of any histological subtype
- Planned, standard of care treatment consisting of neoadjuvant chemotherapy, tumor reduction surgery, and adjuvant chemotherapy OR tumor reduction surgery with adjuvant chemotherapy
- Ability to read and understand the English language
Who cannot join
- Previously treated for ovarian or endometrial cancer
- History of brain metastases, whole brain irradiation, poorly controlled psychiatric disorders defined by hospitalization within the last 3 months for psychiatric diagnoses, traumatic brain injury, cerebrovascular event, or dementia
- Currently taking anti-amyloid agents, cholinesterase inhibitors, or glutamate regulator
- Documented physical or psychological comorbidity that would limit participant's ability to understand or comply with study procedures for the entire length of the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Brittany Lees, MD, 704-355-2000, Brittany.lees@advocatehealth.org
Brittany Lees, MD
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Brandy Baker, (336) 713-0031, jwyche@wakehealth.edu
Bumsoo Ahn, PhD
About this study
Official title: The Role of Mitochondrial Bioenergetics in Resilience in Older Adults With Gynecologic Cancer Receiving Cancer Reductive Treatment
The purpose of this research study is to see if patients with endometrial and ovarian cancer are willing to complete physical and cognitive assessments before treatment and again after treatment has ended.
Read the detailed description
This is a prospective, non-randomized, pilot study that is designed to determine the feasibility of assessing resilience in participants 50 years or older with newly diagnosed advanced endometrial or ovarian cancer who are undergoing tumor reduction surgery and chemotherapy. The study will include pre and post treatment measures of physical and cognitive resiliency such as the Short Physical Performance Battery (SPPB),12 Edmonton Symptom Assessment System Revised (ESAS-r),13 and handgrip strength, International Cognitive Cancer Task Force (ICCTF) Battery14 and the Naming Test from the Neuropsychological Assessment Battery (NAB).
In addition, blood and muscle tissues will be collected at baseline and at the time of surgery, respectively for correlative studies to measure mitochondrial respiration.
- Conditions
- Gynecologycal Cancer
- Being tested
- muscle sample, blood draw
- Keywords
- Mitochondrial Bioenergetics, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle sampleDiagnostic test
For participants undergoing standard of care interval cytoreductive surgery via laparotomy, a skeletal muscle biopsy from the rectus abdominis muscle (1 cm x 1 cm x 1 cm, ~300 mg) will be collected.
For participants who undergo standard of care interval cytoreductive surgery with a laparoscopic approach, a skeletal muscle biopsy will be taken from either the rectus abdominis (1 cm x 1 cm x 1 cm, ~300 mg) or the psoas (1 cm x 0.5 cm x 0.5 cm, ~200 mg) muscle.
blood drawOther
A total of approximately 60mL or 4 tablespoons of blood will be collected throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Advanced gynecological cancers | Participants 50 years and older with suspected or newly diagnosed advanced gynecological cancer (ovarian/primary peritoneal/fallopian tube or endometrial carcinoma of any histological subtype) who are planned to undergo SOC treatment. Receives: Diagnostic Test: muscle sample; Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
Proportion of approached patients who signed consent out of the total number of patients who were approached
Measured: Screening
Enrollment rate
Proportion of consented participants who initiated at least one pretreatment assessment or had pretreatment blood drawn out of the total number of consented participants
Measured: Screening and pretreatment
Completion rate
Proportion of enrolled participants who completed at least one posttreatment assessment (cognitive or physical) out of the total number of enrolled participants
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.
Study Feasibility
≥80% enrollment rate, ≥80% completion rate (30 of 37)
Measured: Screening and up to 30 days following the completion of adjuvant chemotherapy
Secondary outcomes (14)
Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue 7a)
The PROMIS Fatigue 7a is a validated seven-item questionnaire assessing fatigue severity and its impact on daily activities during the past 7 days. Each item is rated on a 5-point scale. Raw scores range from 7 to 35, with higher scores indicating greater fatigue.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.
Short Physical Performance Battery (SPPB)
The SPPB is a measure of lower-extremity physical function consisting of three components: walking speed, repeated chair stands, and standing balance in three increasingly difficult positions.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Gait Speed
Walking speed is assessed by asking the participants to walk at their usual pace over a 4-meter course. Walking speed is scored from zero to four, with four indicating the highest level of performance and zero indicating an inability to complete the task.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Chair stand tests
The time to complete the task will be recorded. Repeated chair stands is scored from zero to four, with four indicating the highest level of performance and zero indicating an inability to complete the task.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Balance tests
For the test of standing balance, participants are asked to maintain balance in three positions, characterized by a progressive narrowing of the base of support: feet together (side-by-side), the heel of one foot beside the big toe of the other foot (semi-tandem), and the heel of one foot in front of and touching the toes of the other foot (tandem). For each of the three positions, participants are timed to a maximum of 10 seconds. Standing balance is scored from zero to four, with four indicating the highest level of performance and zero indicating an inability to complete the task.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Handgrip strength
Handgrip strength is a fundamental measure of upper body muscle strength and overall physical fitness.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Hopkins Verbal Learning Test-Revised (HVLT-R) retention score
Raw scores from the three learning trials are combined into a total recall score. The number of recalled words during the delayed recall portion of the test is the delayed recall score. The retention score (%) is the result of the delayed recall score divided by the highest raw score from learning trial #2 or learning trial #3.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Trail-Making Test (TMT) A
TMT-A measures psychomotor speed, visuospatial search, and target-directed motor tracking.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Trail-Making Test (TMT) B
TMT-B measures executive functions such as cognitive flexibility and set-shifting.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Controlled Oral Word Association Test (COWAT) from the Multilingual Aphasia Examination (MAE)
The COWAT measures the speed of lexical access, which is the ability to retrieve the meaning and pronunciation of a word from one's mental dictionary.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Neuropsychological Assessment Battery (NAB) Naming Test
Participant is shown 31 color photographs of objects. The participant is allowed 10 seconds to recall the name of each object.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Complex I- and II-induced maximum oxygen consumption rate in PBMC
Maximum oxygen consumption rates from mitochondrial complexes I and II are measured by adding specific substrates that activate each complex in PBMCs
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Complex I- and II-induced maximum oxygen consumption rate in muscle
Maximum oxygen consumption rates from mitochondrial complexes I and II are measured by adding specific substrates that activate each complex in muscle tissue
Measured: Cytoreductive Surgery
Wechsler Adult Intelligence Scale - 3rd Edition (WAIS-III) Digit Span subtest
Participant recalls sequences of numbers in forward and backward order. Sequences are read at a rate of 1 digit per second and increase in length until the participant fails two consecutive sequences of the same length.
Measured: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start10 Mar 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologycal CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bumsoo Ahn, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046936
- Sponsor's protocol ID
- IRB00128756
- Other IDs
- P30CA012197, ONC-GYN-2402
- Acronym
- MITO-RES
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mitochondrial Bioenergetics in Resilience in Older Adults With Gynecologic Cancer Receiving Cancer Reductive Treatment
- ClinicalTrials.gov ID
- NCT07046936
- Acronym / sponsor ID
- MITO-RES / IRB00128756
- Conditions
- Gynecologycal Cancer
- Keywords
- Mitochondrial Bioenergetics, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Jul 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.
The purpose of this research study is to see if patients with endometrial and ovarian cancer are willing to complete physical and cognitive assessments before treatment and again after treatment has ended.
Detailed description
This is a prospective, non-randomized, pilot study that is designed to determine the feasibility of assessing resilience in participants 50 years or older with newly diagnosed advanced endometrial or ovarian cancer who are undergoing tumor reduction surgery and chemotherapy. The study will include pre and post treatment measures of physical and cognitive resiliency such as the Short Physical Performance Battery (SPPB),12 Edmonton Symptom Assessment System Revised (ESAS-r),13 and handgrip strength, International Cognitive Cancer Task Force (ICCTF) Battery14 and the Naming Test from the Neuropsychological Assessment Battery (NAB).
In addition, blood and muscle tissues will be collected at baseline and at the time of surgery, respectively for correlative studies to measure mitochondrial respiration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced gynecological cancers | – | Diagnostic Test: muscle sample, Other: blood drawParticipants 50 years and older with suspected or newly diagnosed advanced gynecological cancer (ovarian/primary peritoneal/fallopian tube or endometrial carcinoma of any histological subtype) who are planned to undergo SOC treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a suspected or confirmed diagnosis of ovarian, primary peritoneal, fallopian tube, or endometrial cancer with planned standard of care treatment.
Key inclusion criteria (5 listed)
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age ≥50 years at the time of enrollment
- Newly diagnosed or suspected FIGO Stage II-IV ovarian/primary peritoneal/fallopian tube carcinoma of any histological subtype OR FIGO Stage II-IV endometrial carcinoma of any histological subtype
- Planned, standard of care treatment consisting of neoadjuvant chemotherapy, tumor reduction surgery, and adjuvant chemotherapy OR tumor reduction surgery with adjuvant chemotherapy
- Ability to read and understand the English language
Key exclusion criteria (4 listed)
- Previously treated for ovarian or endometrial cancer
- History of brain metastases, whole brain irradiation, poorly controlled psychiatric disorders defined by hospitalization within the last 3 months for psychiatric diagnoses, traumatic brain injury, cerebrovascular event, or dementia
- Currently taking anti-amyloid agents, cholinesterase inhibitors, or glutamate regulator
- Documented physical or psychological comorbidity that would limit participant's ability to understand or comply with study procedures for the entire length of the study
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 |
|---|---|---|
| muscle sampleFor participants undergoing standard of care interval cytoreductive surgery via laparotomy, a skeletal muscle biopsy from the rectus abdominis muscle (1 cm x 1 cm x 1 cm, ~300 mg) will be collected. For participants who undergo standard of care interval cytoreductive surgery with a laparoscopic approach, a skeletal muscle biopsy will be taken from either the rectus abdominis (1 cm x 1 cm x 1 cm, ~300 mg) or the psoas (1 cm x 0.5 cm x 0.5 cm, ~200 mg) muscle. | Diagnostic test | Advanced gynecological cancers |
| blood drawA total of approximately 60mL or 4 tablespoons of blood will be collected throughout the study | Other | Advanced gynecological cancers |
Primary outcome
Screening rate
Time frame: Screening
Proportion of approached patients who signed consent out of the total number of patients who were approached
Enrollment rate
Time frame: Screening and pretreatment
Proportion of consented participants who initiated at least one pretreatment assessment or had pretreatment blood drawn out of the total number of consented participants
Completion rate
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.
Proportion of enrolled participants who completed at least one posttreatment assessment (cognitive or physical) out of the total number of enrolled participants
Study Feasibility
Time frame: Screening and up to 30 days following the completion of adjuvant chemotherapy
≥80% enrollment rate, ≥80% completion rate (30 of 37)
14 secondary outcomes
Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue 7a)
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.
Short Physical Performance Battery (SPPB)
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Gait Speed
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Chair stand tests
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Balance tests
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Handgrip strength
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Hopkins Verbal Learning Test-Revised (HVLT-R) retention score
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Trail-Making Test (TMT) A
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Trail-Making Test (TMT) B
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Controlled Oral Word Association Test (COWAT) from the Multilingual Aphasia Examination (MAE)
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Neuropsychological Assessment Battery (NAB) Naming Test
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Complex I- and II-induced maximum oxygen consumption rate in PBMC
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy
Complex I- and II-induced maximum oxygen consumption rate in muscle
Time frame: Cytoreductive Surgery
Wechsler Adult Intelligence Scale - 3rd Edition (WAIS-III) Digit Span subtest
Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.
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 30 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Bumsoo Ahn, PhD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologycal Cancer, run by Wake Forest University Health Sciences at 2 sites 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 5 inclusion and 4 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Brandy Baker ((336) 713-8941, brandy.baker@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: Screening). The study lists 4 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 30 Jul 2026.