Clinical Trials

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

Location:

Trial status:

Inactive

Why is this study being done?

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.

Who is eligible to participate?

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.

Last updated: 05/01/2013

NCT ID:

NCT01393821