Gynecologycal Cancer
Conditions
Keywords
Mitochondrial Bioenergetics, Cancer
Brief 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.
Interventions
DIAGNOSTIC_TESTmuscle 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.
OTHERblood draw
A total of approximately 60mL or 4 tablespoons of blood will be collected throughout the study
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening rate | Screening | Proportion of approached patients who signed consent out of the total number of patients who were approached |
| Enrollment rate | 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 | 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 | Screening and up to 30 days following the completion of adjuvant chemotherapy | ≥80% enrollment rate, ≥80% completion rate (30 of 37) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Short Physical Performance Battery (SPPB) | 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. |
| Gait Speed | 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. |
| Chair stand tests | 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. |
| Balance tests | 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. |
| Handgrip strength | 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. |
| Hopkins Verbal Learning Test-Revised (HVLT-R) retention score | 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. |
| Trail-Making Test (TMT) A | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy | TMT-A measures psychomotor speed, visuospatial search, and target-directed motor tracking. |
| Trail-Making Test (TMT) B | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy | TMT-B measures executive functions such as cognitive flexibility and set-shifting. |
| Controlled Oral Word Association Test (COWAT) from the Multilingual Aphasia Examination (MAE) | 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. |
| Neuropsychological Assessment Battery (NAB) Naming Test | 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. |
| Complex I- and II-induced maximum oxygen consumption rate in PBMC | 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 |
| Complex I- and II-induced maximum oxygen consumption rate in muscle | 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 |
| Wechsler Adult Intelligence Scale - 3rd Edition (WAIS-III) Digit Span subtest | 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. |
Countries
United States
Contacts
CONTACTBrandy Baker
PRINCIPAL_INVESTIGATORBumsoo Ahn, PhD
Wake Forest University Health Sciences
Outcome results
None listed