Tracking frailty and thinking before and after pre-surgery chemotherapy for advanced ovarian and endometrial cancer
The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?
This study will see if an automated frailty score and brief thinking tests change after 3–4 cycles of neoadjuvant (pre-surgery) chemotherapy in people over 55 with advanced ovarian or endometrial cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 55 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT07220512 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults over 55 with newly diagnosed advanced ovarian or endometrial cancer who are planned for 3–4 cycles of neoadjuvant chemotherapy and interval cytoreductive surgery. Frailty will be measured using the electronic Frailty Index (eFI) derived from the electronic medical record, and cognitive function and patient-reported outcomes will be captured with MoCA, FACT-Cog, and PHQ-2 before chemotherapy and again after 3–4 cycles of NACT. Surgical and postoperative complication data will be collected to explore relationships between changes in frailty or cognition and operative outcomes. All data collection is non-interventional and occurs at a single cancer center.
Who should consider this trial
Good fit: Ideal participants are English-speaking adults aged over 55 with newly diagnosed FIGO stage II–IV ovarian, primary peritoneal, fallopian tube, or endometrial cancer who plan to receive 3–4 cycles of neoadjuvant chemotherapy followed by interval surgery.
Not a fit: Patients with brain metastases, recent severe psychiatric events, dementia, or those not receiving neoadjuvant chemotherapy with planned interval surgery are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify patients whose frailty or cognition worsens with pre-surgery chemotherapy so they can tailor treatment timing or supportive care.
How similar studies have performed: Automated frailty indices and brief cognitive screens have previously predicted risks and outcomes in older adults with cancer, but using the electronic Frailty Index to track change across neoadjuvant chemotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to understand and willingness to sign an IRB-approved informed consent. * Age \> 55 years at the time of enrollment. * Newly diagnosed suspected ovarian/primary peritoneal/fallopian tube carcinoma of any histological subtype, FIGO Stage II-IV, per enrolling investigator, or newly diagnosed suspected endometrial carcinoma of any histologic subtype, FIGO Stage II-IV, per enrolling investigator. * Planned for 3 or 4 cycles of NACT, with interval cytoreductive surgery planned thereafter. * Ability to read, understand, and write the English language. * As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study. Exclusion Criteria: * History of brain metastases. * History of poorly controlled psychiatric conditions, defined as hospitalization within the prior 3 months for psychiatric disorders, traumatic brain injury, cerebrovascular event, or dementia, per the enrolling investigator. * Use of anti-amyloid agents, cholinesterase inhibitors, or glutamate regulators at the time of enrollment. * Vision impairment that would impede completion of study assessments, per enrolling investigator.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Anna Kuan-Celarier, MD — Wake Forest University Health Sciences
- Study coordinator: Sydney McEntire, RN
- Email: sydney.mcentire@advocatehealth.org
- Phone: 336-713-5879
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.