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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00902 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC16070 | Other Identifier | University of Rochester NCORP Research Base | |
| URCC-16070 | Other Identifier | DCP | |
| R01CA200579 | U.S. NIH Grant/Contract | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.
PRIMARY OBJECTIVES:
I. To determine if control of nausea at cycle 2 in participants who experienced chemotherapy-induced nausea and vomiting (CINV) at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.
SECONDARY OBJECTIVES:
I. To determine if olanzapine is more effective than prochlorperazine in controlling nausea at cycle 2 in participants who experienced CINV at cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.
II. To determine if control of vomiting at cycle 2 in patients who experienced CINV at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.
III. To determine if olanzapine is more effective than prochlorperazine in controlling vomiting at cycle 2 in participants who experienced CINV at cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.
TERTIARY OBJECTIVES:
I. To create an empirically-based algorithm predicting nausea from breast cancer chemotherapy regimens that takes into account not only state-of-the-art anti-emetic regimens but also participant factors such as age, race, education, ethnicity, quality of life (QOL), alcohol consumption, susceptibility to nausea, expectancy, anxiety, level of nausea on the day prior to treatment, and prior history of nausea.
II. To compare the effects of the interventions on QOL, as assessed by the Functional Assessment of Cancer Therapy- General (FACT-G), by following the same procedures described under the primary aim and the first secondary aim, using change in the FACT-G scores as the response.
III. To provide preliminary data on the frequency and severity of sleep disturbance, fatigue, anxiety, and dizziness, across treatment conditions.
IV. To provide preliminary data on biological factors (e.g. glutathione [GSH] recycling, genetic markers) that may help identify a subgroup of patients at high risk for development of cancer-related or treatment-related side effects, or response to treatment.
OUTLINE:
PART I: Patients receive 1 cycle of standard of care chemotherapy.
PART II: Patients with a nausea score >= 3 at least once on the diary at cycle 1 chemotherapy are randomized into 1 of 3 groups at cycle 2.
GROUP I: Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride orally (PO) on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy every 8 hours (Q8H) on days 1-4.
GROUP II: Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
GROUP III: Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
After completion of study treatment, patients are followed up for 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (netupitant/palonosetron hydrochloride, dexamethasone | Experimental | Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4. |
|
| Group II (net/pal hydro, dexa, prochlorperazine, placebo) | Experimental | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4. |
|
| Group III (net/pal hydro, dexa, olanzapine, placebo) | Experimental | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Nausea Defined as the Average [ MAXIMUM ] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm) | Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night). | Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4) |
| Average Nausea Defined as the [AVERAGE] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm) | Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night). | Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4) |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Outcome Variable Will be [ MAXIMUM ] Nausea (Measured on a 7-point Scale Anchored by ("1:Not at All Nauseated" and 7:"Extremely Nauseated"). Difference of Average Nausea Between Control and Experimental Arms Will be Calculated and Compared. | Will be measured on a 7-point scale anchored by "1:not at all nauseated" and "7:extremely nauseated". Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 and 16 assessment points for Cycle 2. This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean. |
| Measure | Description | Time Frame |
|---|---|---|
| Regimens: Chemotherapy Regimens at Cycle 2 | Grouping of Chemotherapy Regimens at Cycle 2 | Cycle 2 Chemotherapy |
| Emetogenic Potential | Emetogenic Potential: The percentage of risk of vomiting based on given chemotherapy agents. Reference: https://pubmed.ncbi.nlm.nih.gov/38129530/ |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke Peppone | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawaii MU NCORP | Honolulu | Hawaii | 96813 | United States | ||
| Decatur Memorial Hospital |
1363 subjects were enrolled. CYCLE 1 which is the First Chemotherapy Cycle (excluded 796 [5 registration errors, 41 no four-day home record, 750 did not have average score of 3 or better]) CYCLE 2 which is the Second Chemotherapy Cycle (excluded 250 [subject decided not to continue on cycle 2]). 317 subjects are available for randomization. 310 subjects were actually randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Total Subjects Randomized |
|
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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 | Jan 4, 2023 |
Not provided
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|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Netupitant/Palonosetron Hydrochloride | Drug | Given PO |
|
|
| Olanzapine | Drug | Given PO |
|
|
| Placebo | Other | Given PO |
|
|
| Prochlorperazine | Drug | Given PO |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4) |
| Vomiting (Yes/No) at Cycle 2 in Participants Who Experienced CINV at Cycle 1. | The response variable will be Any VOMITING (yes/no) after Cycle 2 Chemotherapy, treatment arm as the main factor, and Any Vomiting after Cycle 1 as a covariate. Estimation will be performed using maximum likelihood assuming a binomial distribution and logit link. The same group of contrasts described in the Primary Aim analysis will be estimated and tested, with a significance level of 0.025 to adjust for multiple tests. | Vomiting measured at Cycle 1 Chemotherapy (Yes/No on Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (Yes/No on Days 1,2,3,4) |
| Cycle 2 Chemotherapy |
| Vomiting at Cycle 1 of Chemotherapy | Record of any vomiting (Yes/No) during Cycle 1 of Chemotherapy on Days 1, 2, 3, 4 | Cycle 1 Chemotherapy |
| Vomiting at Cycle 2 of Chemotherapy | Record of any vomiting (Yes/No) during Cycle 2 of Chemotherapy on Days 1, 2, 3, 4 | Cycle 2 Chemotherapy |
| Decatur |
| Illinois |
| 62526 |
| United States |
| Gulf South MU-NCORP | New Orleans | Louisiana | 70112 | United States |
| Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Cancer Research Consortium of West Michigan | Grand Rapids | Michigan | 49503 | United States |
| Health Partners Inc | Minneapolis | Minnesota | 55454 | United States |
| Cancer Research for the Ozarks NCORP | Springfield | Missouri | 65804 | United States |
| Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada | 89106 | United States |
| University of Rochester NCORP Research Base | Rochester | New York | 14642 | United States |
| Southeast Clinical Oncology Research Program | Winston-Salem | North Carolina | 27104 | United States |
| Columbus NCORP | Columbus | Ohio | 43215 | United States |
| Dayton Clinical Oncology Program | Dayton | Ohio | 45459 | United States |
| Geisinger Cancer Institute NCORP | Danville | Pennsylvania | 17822 | United States |
| Greenville NCORP | Greenville | South Carolina | 29615 | United States |
| Upstate Carolina NCORP | Spartanburg | South Carolina | 29303 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | United States |
| Aurora NCORP | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Placebo: Given PO Prochlorperazine: Given PO Quality-of-Life Assessment: Ancillary studies |
| FG002 | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Olanzapine: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
| Second Chemotherapy Cycle (Cycle 2) |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies |
| BG001 | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Placebo: Given PO Prochlorperazine: Given PO Quality-of-Life Assessment: Ancillary studies |
| BG002 | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Olanzapine: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Marital Status | Count of Participants | Participants |
| ||||||||||||||||
| Education | Count of Participants | Participants |
|
| 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 | Average Nausea Defined as the Average [ MAXIMUM ] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm) | Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night). | Posted | Mean | Standard Error | units on a scale | Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Average Nausea Defined as the [AVERAGE] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm) | Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night). | Posted | Mean | Standard Error | units on a scale | Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Secondary Outcome Variable Will be [ MAXIMUM ] Nausea (Measured on a 7-point Scale Anchored by ("1:Not at All Nauseated" and 7:"Extremely Nauseated"). Difference of Average Nausea Between Control and Experimental Arms Will be Calculated and Compared. | Will be measured on a 7-point scale anchored by "1:not at all nauseated" and "7:extremely nauseated". Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 and 16 assessment points for Cycle 2. This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean. | Posted | Mean | Standard Error | units on a scale | Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Vomiting (Yes/No) at Cycle 2 in Participants Who Experienced CINV at Cycle 1. | The response variable will be Any VOMITING (yes/no) after Cycle 2 Chemotherapy, treatment arm as the main factor, and Any Vomiting after Cycle 1 as a covariate. Estimation will be performed using maximum likelihood assuming a binomial distribution and logit link. The same group of contrasts described in the Primary Aim analysis will be estimated and tested, with a significance level of 0.025 to adjust for multiple tests. | Posted | Count of Participants | Participants | Vomiting measured at Cycle 1 Chemotherapy (Yes/No on Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (Yes/No on Days 1,2,3,4) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Regimens: Chemotherapy Regimens at Cycle 2 | Grouping of Chemotherapy Regimens at Cycle 2 | Posted | Count of Participants | Participants | Cycle 2 Chemotherapy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Emetogenic Potential | Emetogenic Potential: The percentage of risk of vomiting based on given chemotherapy agents. Reference: https://pubmed.ncbi.nlm.nih.gov/38129530/ | Posted | Count of Participants | Participants | Cycle 2 Chemotherapy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Vomiting at Cycle 1 of Chemotherapy | Record of any vomiting (Yes/No) during Cycle 1 of Chemotherapy on Days 1, 2, 3, 4 | Posted | Count of Participants | Participants | Cycle 1 Chemotherapy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Vomiting at Cycle 2 of Chemotherapy | Record of any vomiting (Yes/No) during Cycle 2 of Chemotherapy on Days 1, 2, 3, 4 | Posted | Count of Participants | Participants | Cycle 2 Chemotherapy |
|
The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
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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 | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies | 0 | 91 | 1 | 91 | 10 | 91 |
| EG001 | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Placebo: Given PO Prochlorperazine: Given PO Quality-of-Life Assessment: Ancillary studies | 0 | 110 | 3 | 110 | 19 | 110 |
| EG002 | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Olanzapine: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies | 0 | 109 | 3 | 109 | 14 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Mucositis Oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorders, other specify | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Investigations | Systematic Assessment |
| ||
| Restlessness | General disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anxiety | Nervous system disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Akathisia | Nervous system disorders | Systematic Assessment |
| ||
| Eye disorders - Other, specify | Eye disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Lethargy | General disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Dry Mouth | General disorders | Systematic Assessment |
| ||
| Flushing | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hiccups | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Blurred Vision | Eye disorders | Systematic Assessment |
| ||
| Concentration Impairment | Nervous system disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luke J. Peppone, PhD, MPH | University of Rochester Medical Center | 585-275-7827 | Luke_Peppone@urmc.rochester.edu |
| Aug 21, 2025 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2023 | Mar 25, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| C059464 | auricularum |
| C018038 | dexamethasone acetate |
| C004180 | dexamethasone 21-phosphate |
| C508854 | netupitant |
| D000077924 | Palonosetron |
| C000595957 | netupitant, palosentron drug combination |
| D000077152 | Olanzapine |
| D011346 | Prochlorperazine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D010640 | Phenothiazines |
| D006575 | Heterocyclic Compounds, 3-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Divorced |
|
| Separated |
|
| Single |
|
| Widowed |
|
| High School or Less |
|
|
| Mean Difference (Net) |
| 1.1486 |
| 2-Sided |
| Superiority |
| OG002 | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Olanzapine: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies |
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| OG002 | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Olanzapine: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies |
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| OG002 | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Olanzapine: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies |
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Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4. Dexamethasone: Given PO Laboratory Biomarker Analysis: Correlative studies Netupitant/Palonosetron Hydrochloride: Given PO Olanzapine: Given PO Placebo: Given PO Quality-of-Life Assessment: Ancillary studies |
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Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
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Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
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