The Better, Harder, Faster, Stronger Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age55+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • data collection

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Wake Forest Baptist

Collaborator