Overview

This trial is active, not recruiting.

Conditions dermatologic complications, malignant neoplasm, pain
Treatments menadione topical lotion, placebo, questionnaire administration, management of therapy complications
Sponsor Mayo Clinic
Start date January 2012
End date December 2016
Trial size 40 participants
Trial identifier NCT01393821, MC10C9, NCI-2011-01047

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Patients apply menadione topical lotion BID for 28 days.
menadione topical lotion
Given topically
questionnaire administration
Ancillary studies
management of therapy complications complications of therapy, management of
Given menadione topical lotion
(Placebo Comparator)
Patients apply topical placebo lotion BID for 28 days.
placebo PLCB
Given topically
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age 18 years or older. - Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of EGFR inhibitor toxicity. - Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face. - Ability to complete questionnaire(s) by themselves or with assistance. - Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only. - Willing to have photographs taken to assess rash. 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: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects - Use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.