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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-08287 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase III trial compares rose geranium in sesame oil nasal spray to isotonic nasal saline in improving symptoms of nasal vestibulitis in cancer patients receiving chemotherapy. Nasal (nose) symptoms (dryness, discomfort, bleeding, scabbing or sores) due to inflammation, termed nasal vestibulitis, is reported as a side effect of cancer-directed therapy. Rose geranium in sesame oil nasal spray may work better than isotonic nasal saline in improving symptoms of nasal vestibulitis.
PRIMARY OBJECTIVE:
I. To determine the ability of rose geranium in sesame oil nasal spray to alleviate nasal vestibulitis in patients undergoing systemic, antineoplastic therapy when compared with isotonic nasal saline.
SECONDARY OBJECTIVE:
I. To assess toxicities related to rose geranium in sesame oil nasal spray in this study situation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril twice daily (BID) on days 1-14 in the absence of unacceptable toxicity.
ARM B: Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (rose geranium in sesame oil nasal spray) | Experimental | Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. |
|
| Arm B (isotonic nasal saline) | Placebo Comparator | Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Administration | Drug | Instill isotonic nasal saline intranasally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response | Response is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating>>> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test. | At 2 weeks after initiating the nasal spray |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Most Prominent Nasal Symptom Indicated at Baseline | For the most prominent nasal symptom indicated at baseline, patients will record the severity on an ordinal scale of 1=mild, 2=moderate, 3=severe, and 4=very severe. Two weeks after initiating the nasal spray the patients will record the severity of the most prominent nasal symptom as 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. A shift table will be created to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift two-weeks after initiating the nasal spray. In addition, the within-patient change in severity of the most prominent nasal symptom will be calculated 2 weeks after initiating the nasal spray and summarized descriptively within each arm. The Wilcoxon rank-sum test will be performed, and the methods of Hodges and Lehmann will be applied to compute a point estimate and confidence interval for the difference in medians between the two arms. |
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Inclusion Criteria:
REGISTRATION-INCLUSION CRITERIA
Age >= 18 years and be diagnosed with cancer and receiving chemotherapy
Ability to provide informed consent
Willingness to complete questionnaires
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
One or more of the following nasal symptoms for which the patient reports they would appreciate treatment. Symptoms must have started after the initiation of systemic, antineoplastic therapies, be attributed to the systemic, antineoplastic therapies, and symptoms must be reported as being moderate (corresponding to a score of 2) or worse on a scale from mild (1) to very severe (4) on at least one of the items below.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles L Loprinzi | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System in Albert Lea | Albert Lea | Minnesota | 56007 | United States | ||
| Essentia Health Saint Joseph's Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38789656 | Derived | Cathcart-Rake EJ, Steinert K, Smith D, Lewis-Peters S, Giridhar K, Novotny P, Dauer D, O'Connor A, Thome S, Erickson MK, Friday BB, Loprinzi CL. Rose geranium in sesame oil nasal spray to improve nasal vestibulitis symptoms: a randomized controlled trial. Support Care Cancer. 2024 May 24;32(6):379. doi: 10.1007/s00520-024-08580-6. |
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2 patients on Arm A did crossover despite the protocol saying otherwise
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. >> > >> >> > >> Questionnaire Administration: Ancillary studies >> > >> >> > >> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial 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 | May 19, 2022 |
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| Questionnaire Administration |
| Other |
Ancillary studies |
|
| Rose Geranium in Sesame Oil Nasal Spray | Drug | Instill intranasally |
|
| Up to 2 weeks after initiating the nasal spray |
| Nasal Symptom Analysis | Each nasal symptom (dryness, pain, bleeding, and scabbing) will be descriptively summarized, tabulated, and plotted according to arm at baseline, and at 1 and 2 weeks post-baseline; additionally, will group patients according to baseline severity for each symptom and summarize changes over time and according to arm. Shift tables will also be generated to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift one- and two-weeks after initiating the nasal spray. The Nasal symptom scale is 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe with very severe being the worst outcome. | Up to 2 weeks after initiating the nasal spray |
| Number of Participants With Adverse Events (AEs) | The constellation of AEs as scored using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 will be summarized within arms by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles associated with each arm, the maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns and compared between arms using Wilcoxon tests. | Up to 2 weeks after initiating the nasal spray |
| Brainerd |
| Minnesota |
| 56401 |
| United States |
| Essentia Health - Deer River Clinic | Deer River | Minnesota | 56636 | United States |
| Essentia Health Saint Mary's - Detroit Lakes Clinic | Detroit Lakes | Minnesota | 56501 | United States |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | United States |
| Essentia Health Ely Clinic | Ely | Minnesota | 55731 | United States |
| Essentia Health - Fosston | Fosston | Minnesota | 56542 | United States |
| Fairview Grand Itasca Clinic & Hospital | Grand Rapids | Minnesota | 55744 | United States |
| Essentia Health Hibbing Clinic | Hibbing | Minnesota | 55746 | United States |
| Fairview Range Medical Center | Hibbing | Minnesota | 55746 | United States |
| Essentia Health - International Falls Clinic | International Falls | Minnesota | 56649 | United States |
| Mayo Clinic Health Systems-Mankato | Mankato | Minnesota | 56001 | United States |
| Monticello Cancer Center | Monticello | Minnesota | 55362 | United States |
| Essentia Health - Park Rapids | Park Rapids | Minnesota | 56470 | United States |
| Fairview Northland Medical Center | Princeton | Minnesota | 55371 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Essentia Health Sandstone | Sandstone | Minnesota | 55072 | United States |
| Sanford Thief River Falls Medical Center | Thief River Falls | Minnesota | 56701 | United States |
| Essentia Health Virginia Clinic | Virginia | Minnesota | 55792 | United States |
| Sanford Cancer Center Worthington | Worthington | Minnesota | 56187 | United States |
| FG001 |
| Arm B (Isotonic Nasal Saline) |
Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity. >> > >> >> > >> Placebo Administration: Instill isotonic nasal saline intranasally >> > >> >> > >> Questionnaire Administration: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
| Crossover |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.> >>> > >>> Questionnaire Administration: Ancillary studies> >>> > >>> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally |
| BG001 | Arm B (Isotonic Nasal Saline) | Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.> >>> > >>> Questionnaire Administration: Ancillary studies> >>> > >>> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally |
| BG002 | 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 |
| ||||||||||||||||
| Prior treatments for nose symptoms | Count of Participants | Participants |
| ||||||||||||||||
| Prior history of allergies or asthma | Count of Participants | Participants |
| ||||||||||||||||
| Currently smoking | Count of Participants | Participants |
| ||||||||||||||||
| Taking aspirin or blood thinners | Count of Participants | Participants |
| ||||||||||||||||
| Most bothersome nasal symptom | 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 | Response | Response is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating>>> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test. | Posted | Count of Participants | Participants | At 2 weeks after initiating the nasal spray |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Severity of Most Prominent Nasal Symptom Indicated at Baseline | For the most prominent nasal symptom indicated at baseline, patients will record the severity on an ordinal scale of 1=mild, 2=moderate, 3=severe, and 4=very severe. Two weeks after initiating the nasal spray the patients will record the severity of the most prominent nasal symptom as 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. A shift table will be created to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift two-weeks after initiating the nasal spray. In addition, the within-patient change in severity of the most prominent nasal symptom will be calculated 2 weeks after initiating the nasal spray and summarized descriptively within each arm. The Wilcoxon rank-sum test will be performed, and the methods of Hodges and Lehmann will be applied to compute a point estimate and confidence interval for the difference in medians between the two arms. | Posted | Mean | Standard Deviation | "percentage of Week 0 score | Up to 2 weeks after initiating the nasal spray |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Nasal Symptom Analysis | Each nasal symptom (dryness, pain, bleeding, and scabbing) will be descriptively summarized, tabulated, and plotted according to arm at baseline, and at 1 and 2 weeks post-baseline; additionally, will group patients according to baseline severity for each symptom and summarize changes over time and according to arm. Shift tables will also be generated to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift one- and two-weeks after initiating the nasal spray. The Nasal symptom scale is 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe with very severe being the worst outcome. | Some patients missed their post-baseline assessment | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 2 weeks after initiating the nasal spray |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | The constellation of AEs as scored using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 will be summarized within arms by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles associated with each arm, the maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns and compared between arms using Wilcoxon tests. | Posted | Count of Participants | Participants | Up to 2 weeks after initiating the nasal spray |
|
Up to 2 weeks
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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 A (Rose Geranium in Sesame Oil Nasal Spray) | Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally | 0 | 53 | 0 | 53 | 10 | 53 |
| EG001 | Arm B (Isotonic Nasal Saline) | Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally | 0 | 53 | 0 | 53 | 9 | 53 |
| EG002 | Arm A Crossover | Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Arm B Crossover | Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally | 0 | 37 | 0 | 37 | 4 | 37 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 5 | Systematic Assessment |
| |
| Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | CTCAE 5 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Gen disord and admin site conds-Oth spec | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Infections and infestations - Oth spec | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 5 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE 5 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles L. Loprinzi | Mayo Clinic | 507-284-2511 | cloprinzi@mayo.edu |
| Jul 25, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2022 | Jul 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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 |
|
| 1 |
|
| 2 |
|
| 3+ |
|
| Yes |
|
| Discomfort |
|
| Bleeding |
|
| Scabbing |
|
| Sores |
|
| some nasal symptom improvement |
|
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