Role of Mitochondrial Bioenergetics in Resilience for Gynecologic Cancer (MITO-RES)

Wake Forest University (WFU)

Status: Enrolling

Conditions: Gynecologycal Cancer

Treatments: Other: blood draw; Diagnostic Test: muscle sample

Study type: Observational

Funder types: Other

Identifiers

NCT07046936

IRB00128756

ONC-GYN-2402 (Other Identifier)

Details and patient eligibility

About

The purpose of this research study is to see if patients with endometrial and ovarian cancer are willing to complete physical and cognitive assessments before treatment and again after treatment has ended.

Full description

This is a prospective, non-randomized, pilot study that is designed to determine the feasibility of assessing resilience in participants 50 years or older with newly diagnosed advanced endometrial or ovarian cancer who are undergoing tumor reduction surgery and chemotherapy. The study will include pre and post treatment measures of physical and cognitive resiliency such as the Short Physical Performance Battery (SPPB),12 Edmonton Symptom Assessment System Revised (ESAS-r),13 and handgrip strength, International Cognitive Cancer Task Force (ICCTF) Battery14 and the Naming Test from the Neuropsychological Assessment Battery (NAB).

In addition, blood and muscle tissues will be collected at baseline and at the time of surgery, respectively for correlative studies to measure mitochondrial respiration.

Enrollment: 30 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to understand and willingness to sign an IRB-approved informed consent
• Age ≥50 years at the time of enrollment
• Newly diagnosed or suspected FIGO Stage II-IV ovarian/primary peritoneal/fallopian tube carcinoma of any histological subtype OR FIGO Stage II-IV endometrial carcinoma of any histological subtype
• Planned, standard of care treatment consisting of neoadjuvant chemotherapy, tumor reduction surgery, and adjuvant chemotherapy
• Ability to read and understand the English language

Exclusion criteria

• Previously treated for ovarian or endometrial cancer
• History of brain metastases, whole brain irradiation, poorly controlled psychiatric disorders defined by hospitalization within the last 3 months for psychiatric diagnoses, traumatic brain injury, cerebrovascular event, or dementia
• Currently taking anti-amyloid agents, cholinesterase inhibitors, or glutamate regulator
• Documented physical or psychological comorbidity that would limit participant's ability to understand or comply with study procedures for the entire length of the study

Trial design

30 participants in 1 patient group

Advanced gynecological cancers

Description:

Participants 50 years and older with suspected or newly diagnosed advanced gynecological cancer (ovarian/primary peritoneal/fallopian tube or endometrial carcinoma of any histological subtype) who are planned to undergo SOC treatment.

Treatment:

Diagnostic Test: muscle sample

Other: blood draw