Role of Mitochondrial Bioenergetics in Resilience for Gynecologic Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.
• Другое blood draw
  A total of approximately 60mL or 4 tablespoons of blood will be collected throughout the study

Первичные конечные точки

• Screening rate [Срок оценки: Screening]
• Enrollment rate [Срок оценки: Screening and pretreatment]
• Completion rate [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.]
• Study Feasibility [Срок оценки: Screening and up to 30 days following the completion of adjuvant chemotherapy]

Вторичные конечные точки (12)

• Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue 7a) [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.]
• Short Physical Performance Battery (SPPB) [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Gait Speed [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Chair stand tests [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Balance tests [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Handgrip strength [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Hopkins Verbal Learning Test-Revised (HVLT-R) retention score [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Trail-Making Test (TMT) A [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Trail-Making Test (TMT) B [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Controlled Oral Word Association Test (COWAT) from the Multilingual Aphasia Examination (MAE) [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Neuropsychological Assessment Battery (NAB) Naming Test [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]
• Complex I- and II-induced maximum oxygen consumption rate in PBMC [Срок оценки: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Atrium Health Levine Cancer — Charlotte
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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