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 Memantine for Alzheimers/cognitive impairment, 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