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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Mayo Clinic Identifier:
First received: June 27, 2011
Last updated: March 21, 2017
Last verified: April 2016
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 Intervention
Dermatologic Complications Malignant Neoplasm Pain Drug: menadione topical lotion Other: placebo Other: questionnaire administration Procedure: management of therapy complications

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

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

Estimated Enrollment: 40
Actual Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Mayo Clinic Identifier: NCT01393821     History of Changes
Other Study ID Numbers: MC10C9
NCI-2011-01047 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: June 27, 2011
Last Updated: March 21, 2017

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 processed this record on September 21, 2017