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

Mayo Clinic

Status: Completed

Conditions: Malignant Neoplasm; Dermatologic Complications; Pain

Treatments: Drug: menadione topical lotion; Procedure: management of therapy complications; Other: questionnaire administration; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01393821

NCI-2011-01047 (Registry Identifier)

MC10C9

11-001566 (Other Identifier)

R21CA134432 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

Arm I (lotion)

Experimental group

Description:

Patients apply menadione topical lotion BID for 28 days.

Treatment:

Other: questionnaire administration

Procedure: management of therapy complications

Drug: menadione topical lotion

Arm II (placebo)

Placebo Comparator group

Description:

Patients apply topical placebo lotion BID for 28 days.

Treatment:

Other: placebo

Other: questionnaire administration