How mitochondrial function relates to resilience in ovarian and endometrial cancer
The Role of Mitochondrial Bioenergetics in Resilience in Older Adults With Gynecologic Cancer Receiving Cancer Reductive Treatment
This pilot tries whether people 50 and older with advanced ovarian or endometrial cancer will complete physical and cognitive tests plus blood and muscle sampling before and after treatment to see if mitochondrial function links to resilience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT07046936 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized pilot focused on feasibility of measuring physical and cognitive resilience and mitochondrial bioenergetics in patients aged 50 and older with newly diagnosed FIGO stage II–IV ovarian or endometrial cancer. Participants complete pre- and post-treatment measures including the Short Physical Performance Battery, handgrip strength, ESAS-r symptom scores, and cognitive testing (ICCTF battery and NAB Naming Test). Blood is collected at baseline and muscle tissue is obtained at the time of surgery for correlative mitochondrial respiration studies. Clinical care follows standard neoadjuvant chemotherapy, tumor-reduction surgery, and adjuvant chemotherapy while the study evaluates whether these measurements can be collected and related to resilience outcomes.
Who should consider this trial
Good fit: Adults aged 50 or older with newly diagnosed or suspected FIGO stage II–IV ovarian/primary peritoneal/fallopian tube carcinoma or stage II–IV endometrial carcinoma planning standard neoadjuvant chemotherapy, tumor-reduction surgery, and adjuvant chemotherapy who can consent and read English.
Not a fit: Patients previously treated for these cancers, those with brain metastases, dementia, recent severe psychiatric hospitalization, current use of certain cognitive drugs, or other comorbidities preventing sample collection or the planned treatment are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help identify patients at higher risk of functional or cognitive decline so clinicians can tailor supportive care around surgery and chemotherapy.
How similar studies have performed: Some prior research links mitochondrial function to aging and treatment tolerance, but combining mitochondrial respiration measures with detailed physical and cognitive resiliency testing in advanced gynecologic cancers is largely novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Ability to read and understand the English language Exclusion Criteria: * 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
Where this trial is running
Charlotte, North Carolina and 1 other locations
- Atrium Health Levine Cancer — Charlotte, North Carolina, United States (Recruiting)
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Bumsoo Ahn, PhD — Wake Forest University Health Sciences
- Study coordinator: Brandy Baker
- Email: brandy.baker@advocatehealth.org
- Phone: (336) 713-8941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.