Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07046936

Role of Mitochondrial Bioenergetics in Resilience for Gynecologic Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Atrium Health Levine Cancer, Charlotte, North Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 OR tumor reduction surgery with 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

Treatment and study plan

muscle sample

Diagnostic Test

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.

Blood Draw

Other

A total of approximately 60mL or 4 tablespoons of blood will be collected throughout the study

Primary outcomes

  1. Screening rate

    Time frame: Screening

    Proportion of approached patients who signed consent out of the total number of patients who were approached

  2. Enrollment rate

    Time frame: Screening and pretreatment

    Proportion of consented participants who initiated at least one pretreatment assessment or had pretreatment blood drawn out of the total number of consented participants

  3. Completion rate

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.

    Proportion of enrolled participants who completed at least one posttreatment assessment (cognitive or physical) out of the total number of enrolled participants

  4. Study Feasibility

    Time frame: Screening and up to 30 days following the completion of adjuvant chemotherapy

    ≥80% enrollment rate, ≥80% completion rate (30 of 37)

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue 7a)

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.

    The PROMIS Fatigue 7a is a validated seven-item questionnaire assessing fatigue severity and its impact on daily activities during the past 7 days. Each item is rated on a 5-point scale. Raw scores range from 7 to 35, with higher scores indicating greater fatigue.

  2. Short Physical Performance Battery (SPPB)

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    The SPPB is a measure of lower-extremity physical function consisting of three components: walking speed, repeated chair stands, and standing balance in three increasingly difficult positions.

  3. Gait Speed

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    Walking speed is assessed by asking the participants to walk at their usual pace over a 4-meter course. Walking speed is scored from zero to four, with four indicating the highest level of performance and zero indicating an inability to complete the task.

  4. Chair stand tests

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    The time to complete the task will be recorded. Repeated chair stands is scored from zero to four, with four indicating the highest level of performance and zero indicating an inability to complete the task.

  5. Balance tests

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    For the test of standing balance, participants are asked to maintain balance in three positions, characterized by a progressive narrowing of the base of support: feet together (side-by-side), the heel of one foot beside the big toe of the other foot (semi-tandem), and the heel of one foot in front of and touching the toes of the other foot (tandem). For each of the three positions, participants are timed to a maximum of 10 seconds. Standing balance is scored from zero to four, with four indicating the highest level of performance and zero indicating an inability to complete the task.

  6. Handgrip strength

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    Handgrip strength is a fundamental measure of upper body muscle strength and overall physical fitness.

  7. Hopkins Verbal Learning Test-Revised (HVLT-R) retention score

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    Raw scores from the three learning trials are combined into a total recall score. The number of recalled words during the delayed recall portion of the test is the delayed recall score. The retention score (%) is the result of the delayed recall score divided by the highest raw score from learning trial #2 or learning trial #3.

  8. Trail-Making Test (TMT) A

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    TMT-A measures psychomotor speed, visuospatial search, and target-directed motor tracking.

  9. Trail-Making Test (TMT) B

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    TMT-B measures executive functions such as cognitive flexibility and set-shifting.

  10. Controlled Oral Word Association Test (COWAT) from the Multilingual Aphasia Examination (MAE)

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    The COWAT measures the speed of lexical access, which is the ability to retrieve the meaning and pronunciation of a word from one's mental dictionary.

  11. Neuropsychological Assessment Battery (NAB) Naming Test

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    Participant is shown 31 color photographs of objects. The participant is allowed 10 seconds to recall the name of each object.

  12. Complex I- and II-induced maximum oxygen consumption rate in PBMC

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    Maximum oxygen consumption rates from mitochondrial complexes I and II are measured by adding specific substrates that activate each complex in PBMCs

  13. Complex I- and II-induced maximum oxygen consumption rate in muscle

    Time frame: Cytoreductive Surgery

    Maximum oxygen consumption rates from mitochondrial complexes I and II are measured by adding specific substrates that activate each complex in muscle tissue

  14. Wechsler Adult Intelligence Scale - 3rd Edition (WAIS-III) Digit Span subtest

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.

    Participant recalls sequences of numbers in forward and backward order. Sequences are read at a rate of 1 digit per second and increase in length until the participant fails two consecutive sequences of the same length.

Other outcomes

  1. Expression of proteins involved in mitochondrial bioenergetic activities in PBMCs

    Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

    Protein expression related to electron transport chain activity-including components of the Krebs cycle, fatty acid oxidation, and antioxidant pathways-was measured using proteomics in PBMCs

  2. Expression of proteins involved in electron transport chain activities in muscle tissue

    Time frame: Cytoreductive Surgery

    Protein expression related to electron transport chain activity-including components of the Krebs cycle, fatty acid oxidation, and antioxidant pathways-was measured using proteomics in muscle tissue

Study contacts

Contact information is provided by the study sponsor or research team.

Brandy Baker

CONTACT

[email protected]

(336) 713-8941

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: MITO-RES

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.