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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01047 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 11-001566 | Other Identifier | Mayo Clinic Institutional Review Board | |
| R21CA134432 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab
PRIMARY OBJECTIVES:
I. Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.
SECONDARY OBJECTIVES:
I. Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors.
II. Explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients apply menadione topical lotion twice daily (BID) for 28 days.
ARM II: Patients apply topical placebo lotion BID for 28 days.
After completion of study treatment, patients are followed up for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (lotion) | Experimental | Patients apply menadione topical lotion BID for 28 days. |
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| Arm II (placebo) | Placebo Comparator | Patients apply topical placebo lotion BID for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| menadione topical lotion | Drug | Given topically |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort | Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning. | From Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients Experiencing Worst Toxicity | The number of patients experiencing treatment-related adverse events (toxicities) is reported below. The maximum grade toxicity (worst toxicity) is reported by arm. | Up to 8 weeks |
| Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand) |
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Inclusion Criteria:
Exclusion Criteria:
Any active facial and/or chest rash, including adult acne, at the time of randomization.
Cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest.
Use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks.
Any type of ongoing therapy for rash.
Any of the following:
Use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi, M.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Campus in Arizona | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinic |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Menadione) | Patients apply menadione topical lotion BID for 28 days. |
| FG001 | Arm B (Placebo) | Patients apply topical placebo lotion BID for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Other |
Given topically |
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| questionnaire administration | Other | Ancillary studies |
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| management of therapy complications | Procedure | Given menadione topical lotion |
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Least Squares mean (LS) of the Face Pain Scale change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning. |
| Baseline, 4 weeks |
| Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand) | Least Squares mean (LS) of the Psychological Distress Score change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Psychological Distress question ("How often have you been bothered by embarrassment about your face?") with a 0-6 scale, where 0 = Never bothered and 6 = Always bothered. | Baseline, Week 4 |
| Rochester |
| Minnesota |
| 55905 |
| United States |
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| COMPLETED | evaluable for primary endpoint |
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| NOT COMPLETED |
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Excludes cancel patients who never received treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Menadione) | Patients apply menadione topical lotion BID for 28 days. |
| BG001 | Arm B (Placebo) | Patients apply topical placebo lotion BID for 28 days. |
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort | Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning. | Patients who completed the face pain question at baseline and week 4 are included in this analysis. | Posted | Median | Inter-Quartile Range | score on a scale | From Baseline to Week 4 |
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| Secondary | The Number of Patients Experiencing Worst Toxicity | The number of patients experiencing treatment-related adverse events (toxicities) is reported below. The maximum grade toxicity (worst toxicity) is reported by arm. | Excludes cancel patients who never received treatment. | Posted | Count of Participants | Participants | Up to 8 weeks |
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| Secondary | Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand) | Least Squares mean (LS) of the Face Pain Scale change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning. | Excludes cancel patients who never received treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 4 weeks |
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| Secondary | Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand) | Least Squares mean (LS) of the Psychological Distress Score change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Psychological Distress question ("How often have you been bothered by embarrassment about your face?") with a 0-6 scale, where 0 = Never bothered and 6 = Always bothered. | Excludes cancel patients who never received treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 4 |
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Up to 8 weeks
Excludes cancel patients who never received 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 A (Menadione) | Patients apply menadione topical lotion BID for 28 days. | 2 | 12 | 2 | 12 | 11 | 12 |
| EG001 | Arm B (Placebo) | Patients apply topical placebo lotion BID for 28 days. | 0 | 13 | 1 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Stroke | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Facial pain | General disorders | MedDRA 12 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
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| Pain | General disorders | MedDRA 12 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aminah Jatoi, M.D. | Mayo Clinic | (507) 284-7202 | Jatoi.Aminah@mayo.edu |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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