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Recruiting NCT07046936

Role of Mitochondrial Bioenergetics in Resilience for Gynecologic Cancer

— Observational Gynecologycal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: muscle sample, blood draw.
Who it may be relevant to
Registry conditions: Gynecologycal Cancer. Basic parameters: from 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Screening rate [Time frame: Screening]
  • Enrollment rate [Time frame: Screening and pretreatment]
  • Completion rate [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.]
  • Study Feasibility [Time frame: Screening and up to 30 days following the completion of adjuvant chemotherapy]
Secondary outcome measures (12)
  • 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.]
  • Short Physical Performance Battery (SPPB) [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
  • Gait Speed [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
  • Chair stand tests [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
  • Balance tests [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
  • Handgrip strength [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
  • Hopkins Verbal Learning Test-Revised (HVLT-R) retention score [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
  • Trail-Making Test (TMT) A [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
  • Trail-Making Test (TMT) B [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
  • 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]
  • Neuropsychological Assessment Battery (NAB) Naming Test [Time frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Atrium Health Levine Cancer — Charlotte
  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Identifiers

NCT: NCT07046936 · IRB00128756 · P30CA012197 · ONC-GYN-2402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗