Tracking frailty and thinking before and after pre-surgery chemotherapy for advanced ovarian and endometrial cancer
Official title: The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?
Run by Wake Forest University Health Sciences · NCT07220512 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 55 Years and up |
| Sex | Women only |
| Enrollment | 35 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | July 28, 2025 |
| Main results expected | November 2026 |
| Study ends | May 2027 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT07220512 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 Memantine for Alzheimers/cognitive impairment, at the time of enrollment. * Vision impairment that would impede completion of study assessments, per enrolling investigator.
Where it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CR-002 study in adults with advanced solid tumors
This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors
-
Methylation markers in self-samples to help detect gynecological cancers
This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.
-
Radiotherapy for gynecologic cancer with up to 10 metastatic sites
This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.
-
Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy
The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.
-
TS-104: a first-in-human, dose-escalation study for advanced solid tumors
This study tests TS-104, a peptide-drug conjugate, as a single therapy in adults with advanced solid tumors like NSCLC, HNSCC, esophageal, gastric, ovarian, or endometrial cancer to see if it is safe and tolerable and whether it shows any benefit.
-
ARR-002 in advanced ovarian or endometrial cancer
This phase 1 study tests ARR-002 to see if it is safe and tolerable in adults with advanced or metastatic ovarian or endometrial cancer who have limited treatment options.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.