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

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Erlotinib Hydrochloride; Vitamin K; Vitamin K 3

Criteria

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.