NCT07046936

Role of Mitochondrial Bioenergetics in Resilience for Gynecologic Cancer

The Role of Mitochondrial Bioenergetics in Resilience in Older Adults With Gynecologic Cancer Receiving Cancer Reductive Treatment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Gynecologycal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	muscle sample	For participants undergoing standard of care interval cytoreductive surgery via laparotomy, a skeletal muscle biopsy from the rectus abdominis muscle (1 cm x 1 cm x 1 cm, \~300 mg) will be collected. For participants who undergo standard of care interval cytoreductive surgery with a laparoscopic approach, a skeletal muscle biopsy will be taken from either the rectus abdominis (1 cm x 1 cm x 1 cm, \~300 mg) or the psoas (1 cm x 0.5 cm x 0.5 cm, \~200 mg) muscle.
OTHER	blood draw	A total of approximately 60mL or 4 tablespoons of blood will be collected throughout the study

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-07-02
• Last updated: 2026-03-03

Locations

2 sites across 1 country: United States