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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Primary Completion Date: December 2014 (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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393821

Locations
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
Investigators
Study Chair: Aminah Jatoi, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01393821     History of Changes
Other Study ID Numbers: MC10C9, NCI-2011-01047
Study First Received: June 27, 2011
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Vitamin K
Vitamin K 3
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Growth Substances
Hematologic Agents
Hemostatics
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014