Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab
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|ClinicalTrials.gov Identifier: NCT01393821|
Recruitment Status : Active, not recruiting
First Posted : July 13, 2011
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment|
|Dermatologic Complications Malignant Neoplasm Pain||Drug: menadione topical lotion Other: placebo Other: questionnaire administration Procedure: management of therapy complications|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress|
|Actual Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Arm I (lotion)
Patients apply menadione topical lotion BID for 28 days.
Drug: menadione topical lotion
Given topicallyOther: questionnaire administration
Ancillary studiesProcedure: management of therapy complications
Given menadione topical lotion
Other Name: complications of therapy, management of
Placebo Comparator: Arm II (placebo)
Patients apply topical placebo lotion BID for 28 days.
Other Name: PLCBOther: questionnaire administration
- Cutaneous discomfort as measured by the face pain scale question. Descriptive statistics and longitudinal plots will be used for summarizing cutaneous discomfort. [ Time Frame: Weekly during the 4-week treatment period ]
- Adverse event profile of a topical menadione-containing lotion [ Time Frame: 8 weeks ]
- Long-term cutaneous and psychosocial discomfort and adverse event [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393821
|United States, Arizona|
|Mayo Clinic Campus in Arizona|
|Scottsdale, Arizona, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Aminah Jatoi, M.D.||Mayo Clinic|