Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab
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
Drug: menadione topical lotion
Other: questionnaire administration
Procedure: management of therapy complications
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: No ]
- Adverse event profile of a topical menadione-containing lotion [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Long-term cutaneous and psychosocial discomfort and adverse event [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|