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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| ONC-GYN-2402 | Other Identifier | Atrium Health Wake Forest Baptist Comprehensive Cancer Center |
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Study suspended until approval of the next amendment. Next amendment aims to add virtual visits to neuro assessments in order to ensure these are done only by trained psychometrists.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Screening rate | Proportion of approached patients who signed consent out of the total number of patients who were approached | Screening |
| Enrollment rate | Proportion of consented participants who initiated at least one pretreatment assessment or had pretreatment blood drawn out of the total number of consented participants | Screening and pretreatment |
| Completion rate | Proportion of enrolled participants who completed at least one posttreatment assessment (cognitive or physical) out of the total number of enrolled participants | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy. |
| Study Feasibility | ≥80% enrollment rate, ≥80% completion rate (30 of 37) | Screening and up to 30 days following the completion of adjuvant chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Edmonton Symptom Assessment System - Revised (ESAS-r) | The ESAS-r is a tool is widely used and validated to assess nine symptoms, including pain, nausea, depression, anxiety, tiredness, lack of appetite, well-being, shortness of breath, and overall well-being at the time of questionnaire completion. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of proteins involved in mitochondrial bioenergetic activities in PBMCs | 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 | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
Inclusion Criteria:
Exclusion Criteria:
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Participants with a suspected or confirmed diagnosis of ovarian, primary peritoneal, fallopian tube, or endometrial cancer with planned standard of care treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Bumsoo Ahn, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Levine Cancer | Charlotte | North Carolina | 28204 | United States | ||
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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PBMCs and muscle biopsies
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| blood draw | Other | A total of approximately 60mL or 4 tablespoons of blood will be collected throughout the study |
|
| Short Physical Performance Battery (SPPB) | 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. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Walking speed | 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. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Repeated chair stands | 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. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Standing balance | 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. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Handgrip strength | Handgrip strength is a fundamental measure of upper body muscle strength and overall physical fitness. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Hopkins Verbal Learning Test-Revised (HVLT-R) retention score | 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. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Trail-Making Test (TMT) A | TMT-A measures psychomotor speed, visuospatial search, and target-directed motor tracking. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Trail-Making Test (TMT) B | TMT-B measures executive functions such as cognitive flexibility and set-shifting. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Controlled Oral Word Association Test (COWAT) from the Multilingual Aphasia Examination (MAE) | 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. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Neuropsychological Assessment Battery (NAB) Naming Test | Participant is shown 31 color photographs of objects. The participant is allowed 10 seconds to recall the name of each object. | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Complex I- and II-induced maximum oxygen consumption rate in PBMC | Maximum oxygen consumption rates from mitochondrial complexes I and II are measured by adding specific substrates that activate each complex in PBMCs | Pretreatment and up to 30 days following the completion of adjuvant chemotherapy |
| Complex I- and II-induced maximum oxygen consumption rate in muscle | Maximum oxygen consumption rates from mitochondrial complexes I and II are measured by adding specific substrates that activate each complex in muscle tissue | Cytoreductive Surgery |
| Expression of proteins involved in electron transport chain activities in muscle tissue | 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 | Cytoreductive Surgery |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |