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

NCT ID: NCT01393821

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-23
• Study Completion Date: 2018-07-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm I (lotion)

Patients apply menadione topical lotion BID for 28 days.

Group Type: EXPERIMENTAL

menadione topical lotion

Intervention Type: DRUG

Given topically

questionnaire administration

Intervention Type: OTHER

Ancillary studies

management of therapy complications

Intervention Type: PROCEDURE

Given menadione topical lotion

Arm II (placebo)

Patients apply topical placebo lotion BID for 28 days.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given topically

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Interventions

menadione topical lotion

Given topically

Intervention Type: DRUG

placebo

Given topically

Intervention Type: OTHER

questionnaire administration

Ancillary studies

Intervention Type: OTHER

management of therapy complications

Given menadione topical lotion

Intervention Type: PROCEDURE

Other Intervention Names

PLCB; complications of therapy, management of

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aminah Jatoi, M.D.

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic Campus in Arizona

Phoenix, Arizona, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2011-01047

Identifier Type: REGISTRY

Identifier Source: secondary_id

11-001566

Identifier Type: OTHER

Identifier Source: secondary_id

R21CA134432

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MC10C9

Identifier Type: -

Identifier Source: org_study_id