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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01555 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 17327 | Other Identifier | City of Hope Comprehensive Cancer Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well megestrol acetate with or without pterostilbene works in treating patients with endometrial cancer undergoing hysterectomy. Drugs used in chemotherapy, such as megestrol acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pterostilbene is an antioxidant found in blueberries or grapes, and it has been shown to be effective in killing tumor cells and reducing cancer burden. It is not yet known whether giving megestrol acetate with or without pterostilbene may work better in treating patients with endometrial cancer.
PRIMARY OBJECTIVE:
I. Determine the effect of megestrol acetate (MA) plus pterostilbene (PTE) versus MA alone on tumor proliferation (Ki-67) during the preoperative window in patients with endometrial cancer (EC) who are scheduled for hysterectomy.
EXPLORATORY OBJECTIVES:
I. Determine the effect of MA plus PTE versus MA alone on histologic response during the preoperative window in patients with EC or endometrial complex atypical hyperplasia who are scheduled for hysterectomy.
II. Explore biological characteristics of tumors to determine potential biomarkers which could select for treatment eligibility in future studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive pterostilbene orally (PO) twice daily (BID) and megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity.
ARM II: Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity.
After completion of study treatment, patients are followed up at 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (pterostilbene, megestrol acetate) | Experimental | Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. |
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| Arm II (megestrol acetate) | Experimental | Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Megestrol Acetate | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Ki-67 Proliferation Index | Ki-67 represents a specific nuclear marker for cell proliferation that is measured by staining with specific antibodies by immunohistochemical (IHC) staining. The Ki-67 proliferation index is defined as percent tumor cells staining positive, and measured on a continuous scale of 0-100%, with higher values indicating higher proliferation. Ki-67 hotspot values were assessed at two time-points during this study, prior to treatment with megace +/- pterostilbene (pre-treatment), and following completion of treatment (post-treatment). Descriptive statistics were used to compare treatment-associated percent change in Ki-67 proliferation index between the 2 study arms, using a 1-sided test with significance at p < 0.05. | Pre- and post-treatment up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic Response of Gland Cellularity | These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). Gland cellularity will be assessed by counting the number of cells in one quarter of a high-power field (HPF) (average of 3 fields). The number of patients with an improvement in gland cellularity were compared between study arms. |
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Inclusion Criteria:
Documented informed consent of the participant and/or legally authorized representative
Willing to undergo an intraoperative biopsy/or standard of care tissue collection during surgery, following completion of treatment with MA +/- PTE
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Histologically confirmed EC or complex atypical hyperplasia of the endometrium
Candidate for a total hysterectomy with or without bilateral salpingo-oophorectomy
About to initiate preoperative window period, with planned hysterectomy scheduled
Platelets >= 100,000/mm^3
Total bilirubin =< 1.5 X upper limit of normal (ULN)
Aspartate aminotransferase (AST) =< 1.5 x ULN
Alanine aminotransferase (ALT) =< 1.5 x ULN
Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Women of childbearing potential: negative urine or serum pregnancy test in premenopausal women. Postmenopausal women do not need to undergo a pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Exclusion Criteria:
Pterostilbene supplements within 30 days prior to day 1 of protocol therapy
Any of the following phytochemical-based supplements within 30 days prior to day 1 of protocol therapy: resveratrol, genistein, and quercetin
Chemotherapy for EC
Allergic reaction/hypersensitivity to similar agents, excipients
Unstable cardiac disease as defined by one of the following:
Active or history of recent thromboembolism or stroke, within the past 6 months
Cushing's syndrome
Acute infection requiring systemic (intravenous) treatment
Known history of human immunodeficiency virus (HIV) infection
Known active hepatitis B or C infection
Inability to swallow tablets/capsules
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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| Name | Affiliation | Role |
|---|---|---|
| Thanh H Dellinger | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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A total of 44 patients were accrued. Seven patients were not evaluable for various reasons: received <10 days of study treatment (n = 5), disenrolled (n = 1), did not receive hysterectomy (n = 1). Consequently, 37 patients were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Pterostilbene, Megestrol Acetate) | Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO |
| FG001 | Arm II (Megestrol Acetate) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2022 |
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| Pterostilbene | Biological | Given PO |
|
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| Up to 6 weeks |
| Histologic Response of Mitotic Index | These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). The mitotic index will be calculated as the number of mitoses per HPF (average of 3 fields). The number of patients with an improvement in mitotic index were compared between study arms. | Up to 6 weeks |
| Histologic Response of Metaplasia | These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). The percentages of tumor that display squamous or mucinous metaplasia will be estimated as percentages, with < 10% considered negative and >= 10% as positive. The number of patients with an improvement in metaplasia were compared between study arms. | Up to 6 weeks |
| Histologic Response of Eosinophilic Metaplasia | These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). The number of patients with an improvement in eosinophilic metaplasia were compared between study arms. | Up to 6 weeks |
| Immunohistochemical Expression of Bcl-2 to Assess Tumor Growth and Apoptosis | Immunohistochemistry stains with antibodies directed against Bcl-2 will be performed on pre- and post-treatment endometrial samples. Samples will be scored on a continuous scale (0-100%) using the product of the intensity of cytoplasmic staining, and the proportion of cells staining based on the distribution of staining. Descriptive statistics were used to compare the percent change in scores from pre-treatment to post-treatment between the 2 study arms. | Pre- and post-treatment up to 6 weeks |
| Immunohistochemical Expression of Casp3 to Assess Tumor Growth and Apoptosis | Immunohistochemistry stains with antibodies directed against Casp3 to assess apoptosis will be performed on pre- and post-treatment endometrial samples. Samples will be scored by counting the number of positive staining nuclei per HPF. Descriptive statistics were used to compare the percent change in scores from pre-treatment to post-treatment between the 2 study arms. | Pre- and post-treatment up to 6 weeks |
Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Pterostilbene, Megestrol Acetate) | Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO |
| BG001 | Arm II (Megestrol Acetate) | Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Ki-67 Proliferation Index | Ki-67 represents a specific nuclear marker for cell proliferation that is measured by staining with specific antibodies by immunohistochemical (IHC) staining. The Ki-67 proliferation index is defined as percent tumor cells staining positive, and measured on a continuous scale of 0-100%, with higher values indicating higher proliferation. Ki-67 hotspot values were assessed at two time-points during this study, prior to treatment with megace +/- pterostilbene (pre-treatment), and following completion of treatment (post-treatment). Descriptive statistics were used to compare treatment-associated percent change in Ki-67 proliferation index between the 2 study arms, using a 1-sided test with significance at p < 0.05. | Posted | Mean | Standard Deviation | percent change | Pre- and post-treatment up to 6 weeks |
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| Secondary | Histologic Response of Gland Cellularity | These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). Gland cellularity will be assessed by counting the number of cells in one quarter of a high-power field (HPF) (average of 3 fields). The number of patients with an improvement in gland cellularity were compared between study arms. | Only 36 patients had data for this endpoint. | Posted | Count of Participants | Participants | Up to 6 weeks |
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| Secondary | Histologic Response of Mitotic Index | These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). The mitotic index will be calculated as the number of mitoses per HPF (average of 3 fields). The number of patients with an improvement in mitotic index were compared between study arms. | Only 36 patients had data for this endpoint. | Posted | Count of Participants | Participants | Up to 6 weeks |
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| Secondary | Histologic Response of Metaplasia | These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). The percentages of tumor that display squamous or mucinous metaplasia will be estimated as percentages, with < 10% considered negative and >= 10% as positive. The number of patients with an improvement in metaplasia were compared between study arms. | Only 36 patients had data for this endpoint. | Posted | Count of Participants | Participants | Up to 6 weeks |
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| Secondary | Histologic Response of Eosinophilic Metaplasia | These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). The number of patients with an improvement in eosinophilic metaplasia were compared between study arms. | Only 36 patients had data for this endpoint. | Posted | Count of Participants | Participants | Up to 6 weeks |
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| Secondary | Immunohistochemical Expression of Bcl-2 to Assess Tumor Growth and Apoptosis | Immunohistochemistry stains with antibodies directed against Bcl-2 will be performed on pre- and post-treatment endometrial samples. Samples will be scored on a continuous scale (0-100%) using the product of the intensity of cytoplasmic staining, and the proportion of cells staining based on the distribution of staining. Descriptive statistics were used to compare the percent change in scores from pre-treatment to post-treatment between the 2 study arms. | Only 33 patients had data for this endpoint. | Posted | Mean | Standard Deviation | percent change | Pre- and post-treatment up to 6 weeks |
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| Secondary | Immunohistochemical Expression of Casp3 to Assess Tumor Growth and Apoptosis | Immunohistochemistry stains with antibodies directed against Casp3 to assess apoptosis will be performed on pre- and post-treatment endometrial samples. Samples will be scored by counting the number of positive staining nuclei per HPF. Descriptive statistics were used to compare the percent change in scores from pre-treatment to post-treatment between the 2 study arms. | Only 25 patients had data for this endpoint. | Posted | Mean | Standard Deviation | percent change | Pre- and post-treatment up to 6 weeks |
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Adverse events were assessed from the time of surgery until the 6-week post-suregry visit.
"Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Pterostilbene, Megestrol Acetate) | Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO | 0 | 19 | 0 | 19 | 16 | 19 |
| EG001 | Arm II (Megestrol Acetate) | Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO | 0 | 18 | 0 | 18 | 15 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Chills | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
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| cramping | General disorders | Non-systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Cholesterol high | Investigations | Non-systematic Assessment |
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| Platelet count decreased | Investigations | Non-systematic Assessment |
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| Weight gain | Investigations | Non-systematic Assessment |
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| White blood cell decreased | Investigations | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | Non-systematic Assessment |
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| increased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
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| Urinary tract pain | Renal and urinary disorders | Non-systematic Assessment |
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| Urinary urgency | Renal and urinary disorders | Non-systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | Non-systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vaginal hemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hot flashes | Vascular disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 6262185265 | pfrankel@coh.org |
| Dec 3, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 24, 2022 | Dec 3, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004714 | Endometrial Hyperplasia |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| C000721168 | Pterocarpus marsupium |
| C506282 | 3,5-dimethoxy-4'-hydroxystilbene |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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