NCT01393821

Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Dermatologic Complications
• Malignant Neoplasm
• Pain

Interventions

Type	Name	Description
DRUG	menadione topical lotion	Given topically
OTHER	placebo	Given topically
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	management of therapy complications	Given menadione topical lotion

Timeline

• Start date: 2012-01-23
• Primary completion: 2013-05-11
• Completion: 2018-07-14
• First posted: 2011-07-13
• Last updated: 2025-05-16
• Results posted: 2019-10-16

Locations

2 sites across 1 country: United States