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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01393821
Recruitment Status : Active, not recruiting
First Posted : July 13, 2011
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
Mayo Clinic

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

Condition or disease Intervention/treatment
Dermatologic Complications Malignant Neoplasm Pain Drug: menadione topical lotion Other: placebo Other: questionnaire administration Procedure: management of therapy complications

Detailed Description:


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.


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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Menadione
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I (lotion)
Patients apply menadione topical lotion BID for 28 days.
Drug: menadione topical lotion
Given topically
Other: questionnaire administration
Ancillary studies
Procedure: management of therapy complications
Given menadione topical lotion
Other Name: complications of therapy, management of
Placebo Comparator: Arm II (placebo)
Patients apply topical placebo lotion BID for 28 days.
Other: placebo
Given topically
Other Name: PLCB
Other: questionnaire administration
Ancillary studies

Primary Outcome Measures :
  1. Cutaneous discomfort as measured by the face pain scale question. Descriptive statistics and longitudinal plots will be used for summarizing cutaneous discomfort. [ Time Frame: Weekly during the 4-week treatment period ]

Secondary Outcome Measures :
  1. Adverse event profile of a topical menadione-containing lotion [ Time Frame: 8 weeks ]
  2. Long-term cutaneous and psychosocial discomfort and adverse event [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393821

United States, Arizona
Mayo Clinic Campus in Arizona
Scottsdale, Arizona, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Study Chair: Aminah Jatoi, M.D. Mayo Clinic

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01393821     History of Changes
Other Study ID Numbers: MC10C9
NCI-2011-01047 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Erlotinib Hydrochloride
Vitamin K 3
Vitamin K
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Growth Substances
Physiological Effects of Drugs