Menadione Lotion for Cancer-Related Skin Discomfort

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Epidermal growth inhibitors

Must not be taking: Topical corticosteroids, Antibiotics

Disqualifiers: Active rash, Skin cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies a menadione lotion to help cancer patients with skin discomfort and distress from their treatments. The lotion is applied to the skin to soothe and protect it, aiming to reduce rashes and pain. Menadione, also known as vitamin K3, has been studied for its potential to activate certain skin receptors and reduce skin rashes caused by cancer treatments.

Research Team

Aminah Jatoi, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Adults starting or within 3 days of beginning treatment with panitumumab, erlotinib hydrochloride, or cetuximab for cancer. Participants must be able to apply lotion twice daily and complete questionnaires. Excluded are those using certain skin treatments, pregnant or nursing women, and individuals not practicing contraception.

Inclusion Criteria

I am 18 years old or older.

I can apply a lotion to my face twice daily without help.

Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria

I have skin cancer or precancerous skin lesions on my face/chest.

Pregnant women

I am currently receiving treatment for a rash.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply menadione topical lotion or placebo twice daily for 28 days

4 weeks

Regular self-application, no specific visit schedule mentioned

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Management of Therapy Complications
• Menadione Topical Lotion
• Placebo
• Questionnaire Administration

Trial Overview The trial is testing menadione topical lotion versus a placebo to see if it can prevent skin discomfort and reduce psychological distress in patients treated with specific cancer drugs. It includes applying the lotion regularly and answering questionnaires about their condition.

Participant Groups

Group I: Arm I (lotion) Experimental Treatment 3 Interventions

Patients apply menadione topical lotion BID for 28 days.

Group II: Arm II (placebo) Placebo Group 2 Interventions

Patients apply topical placebo lotion BID for 28 days.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+