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A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress


N/A
18 Years
N/A
Open (Enrolling)
Both
Dermatologic Complications, Malignant Neoplasm, Pain

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Trial Information

A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Cutaneous discomfort as measured by the face pain scale question. Descriptive statistics and longitudinal plots will be used for summarizing cutaneous discomfort.

Outcome Time Frame:

Weekly during the 4-week treatment period

Safety Issue:

No

Principal Investigator

Aminah Jatoi, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

MC10C9

NCT ID:

NCT01393821

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Dermatologic Complications
  • Malignant Neoplasm
  • Pain
  • Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
Mayo Clinic Campus in ArizonaScottsdale, Arizona