The Role of Mitochondrial Bioenergetics in Resilience in Older Adults With Gynecologic Cancer Receiving Cancer Reductive Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Screening rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Advanced gynecological cancers
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.
干预措施: muscle sample (Diagnostic Test)
Advanced gynecological cancers
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.
干预措施: blood draw (Other)
结局指标
主要结局
Screening rate
时间窗: Screening
Proportion of approached patients who signed consent out of the total number of patients who were approached
Enrollment rate
时间窗: 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
Completion rate
时间窗: 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
Study Feasibility
时间窗: Screening and up to 30 days following the completion of adjuvant chemotherapy
≥80% enrollment rate, ≥80% completion rate (30 of 37)
次要结局
- Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue 7a)(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.)
- Gait Speed(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Chair stand tests(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Balance tests(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Wechsler Adult Intelligence Scale - 3rd Edition (WAIS-III) Digit Span subtest(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.)
- Hopkins Verbal Learning Test-Revised (HVLT-R) retention score(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Controlled Oral Word Association Test (COWAT) from the Multilingual Aphasia Examination (MAE)(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Neuropsychological Assessment Battery (NAB) Naming Test(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Complex I- and II-induced maximum oxygen consumption rate in muscle(Cytoreductive Surgery)
- Handgrip strength(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Short Physical Performance Battery (SPPB)(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Complex I- and II-induced maximum oxygen consumption rate in PBMC(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Trail-Making Test (TMT) A(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)
- Trail-Making Test (TMT) B(Pretreatment and up to 30 days following the completion of adjuvant chemotherapy)