Recruiting

NACT

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07220512

Conditions

Frailty at Older Adults

Ovarian Cancer

Endometrial Cancer

Cognitive Dysfunction

Neoadjuvant Chemotherapy

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

Interventions

data collection

Study Details

Brief summary:

The purpose of this study is to evaluate changes in the electronic Frailty Index (eFI) score following 3-4 cycles of neoadjuvant chemotherapy (NACT) in participants with advanced ovarian and endometrial cancer.

Conditions

Frailty at Older Adults

Ovarian Cancer

Endometrial Cancer

Cognitive Dysfunction

Neoadjuvant Chemotherapy

Study ID

NCT07220512

Start date

Jul 28, 2025

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with ovarian or endometrial carcinoma with planned NACT.

Participants over 55 years old with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma

Interventions

data collection

PROs, historical and longitudinal data collection and eFI calculation

Primary outcome measure

  • Change in electronic frailty index (eFI) [ Time Frame: From pre- Neoadjuvant Chemotherapy (NACT; no later than 60 days after consent) to post-NACT (no later than 30 days after completion of the last cycle of NACT) ]

Central Contacts and Locations

Central contacts

Sydney McEntire, RN

336-713-5879sydney.mcentire@advocatehealth.org

Locations

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Sydney McEntire, RN

336-713-5879sydney.mcentire@advocatehealth.org

Principal Investigator:

Anna Kuan-Celarier, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Frailty
  • ovarian cancer
  • endometrial cancer
  • cognitive dysfunction
  • neoadjuvant chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-15.