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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.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01393821
First received: June 27, 2011
Last updated: July 14, 2014
Last verified: July 2014

June 27, 2011
July 14, 2014
January 2012
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01393821 on ClinicalTrials.gov Archive Site
  • Adverse event profile of a topical menadione-containing lotion [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Long-term cutaneous and psychosocial discomfort and adverse event [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Dermatologic Complications
  • Malignant Neoplasm
  • Pain
  • Drug: menadione topical lotion
    Given topically
  • Other: placebo
    Given topically
    Other Name: PLCB
  • Other: questionnaire administration
    Ancillary studies
  • Procedure: management of therapy complications
    Given menadione topical lotion
    Other Name: complications of therapy, management of
  • Experimental: Arm I (lotion)
    Patients apply menadione topical lotion BID for 28 days.
    Interventions:
    • Drug: menadione topical lotion
    • Other: questionnaire administration
    • Procedure: management of therapy complications
  • Placebo Comparator: Arm II (placebo)
    Patients apply topical placebo lotion BID for 28 days.
    Interventions:
    • Other: placebo
    • Other: questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01393821
MC10C9, NCI-2011-01047
Yes
Mayo Clinic
Mayo Clinic
Not Provided
Study Chair: Aminah Jatoi, M.D. Mayo Clinic
Mayo Clinic
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP