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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a menadione topical lotion to alleviate skin discomfort and psychological distress in cancer patients. It targets those about to start or who have just started treatments like panitumumab, erlotinib, or cetuximab, which can cause skin issues. Participants will use either the menadione lotion or a placebo (a lotion with no active ingredients) for 28 days. Ideal candidates can apply the lotion twice daily and complete questionnaires about their experience. Those with an existing facial rash or using certain skin medications are not eligible. As an unphased trial, this study provides a unique opportunity to contribute to research that may enhance the quality of life for cancer patients.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that menadione lotion is generally safe and easy to use. Studies on its use for skin problems caused by cancer treatments have shown promising results. For example, one study found that menadione lotion effectively prevented skin issues like rashes and dry skin, which often occur with certain cancer medications. Importantly, no major side effects were reported with the use of menadione lotion.

Another study confirmed these findings, noting that menadione can help with skin discomfort without causing serious side effects. While this research is encouraging, participants should always discuss potential risks and benefits with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cancer-related skin discomfort, which often involve oral medications or systemic therapies, Menadione Lotion is applied directly to the skin. This topical approach targets the discomfort at the source without the potential side effects of systemic treatments. Researchers are excited because Menadione, a form of vitamin K, has unique properties that might help soothe skin irritation more effectively and with fewer side effects. This direct and potentially safer method of delivering relief could make a significant difference for patients dealing with cancer-related skin issues.

What evidence suggests that menadione topical lotion might be an effective treatment for cancer-related skin discomfort?

Research has shown that menadione lotion, a form of Vitamin K3, might help reduce skin discomfort from cancer treatments like panitumumab, erlotinib hydrochloride, and cetuximab. These treatments often cause skin rashes and irritation, affecting about two-thirds of patients. In this trial, participants in one arm will apply menadione topical lotion, which earlier trials have tested and found effective for these skin issues. Early trials indicated that the lotion is safe and well-tolerated when used on the skin. It likely works by blocking certain enzymes that cause skin irritation, potentially lessening the distress and pain from these skin problems. ^{1 2 3 5 6}

Who Is on the Research Team?

Aminah Jatoi, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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

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

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

Exclusion Criteria

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

Pregnant women

I am using or plan to use topical corticosteroids on my face or chest.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jaad.org jaad.org/article/S0190-9622(14)00634-3/fulltext

Menadione topical lotion for the prevention of skin toxicity ... Results: Combined data for 12 healthy subjects and 14 cancer patients were evaluated. Irrespective of study population, MTL concentration and sampling time ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00656786

Safety, Tolerability and Systemic Absorption of Menadione ... Evaluate the systemic absorption and bioavailability of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash.

3. aacrjournals.org aacrjournals.org/clincancerres/article/17/21/6766/76848/The-Phosphatase-Inhibitor-Menadione-Vitamin-K3

The Phosphatase Inhibitor Menadione (Vitamin K3) Protects ... The main side effect of these agents is a cutaneous toxicity that occurs in about two-thirds of the patients, the most common manifestation being an ...

4. ctv.veeva.com ctv.veeva.com/study/menadione-topical-lotion-in-treating-skin-discomfort-and-psychological-distress-in-patients-with-can

Menadione Topical Lotion in Treating Skin Discomfort and ... This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer ...

5. ascopubs.org ascopubs.org/doi/10.1200/jco.2006.24.18_suppl.3036

Topical vitamin K3 (Vit K3, Menadione) prevents erlotinib ... The occurrence of skin toxicity correlates with clinical benefit. About half the patients with skin toxicity report significant discomfort.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3228080/

Management of Skin Toxicity Associated with Cetuximab ... The major side effect associated with cetuximab treatment is skin toxicity, including skin rash, dry skin, hair growth disorders, pruritus, and nail changes [15 ...