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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 October 2012 |
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Main ID: |
NCT01393821 |
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Date of registration:
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27/06/2011 |
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Primary sponsor: |
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Public title:
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Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab
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Scientific title:
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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 |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01393821 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Aminah Jatoi, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dermatologic Complications
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Malignant Neoplasm
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Pain
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Intervention(s)
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Drug: menadione topical lotion
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Other: placebo
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Other: questionnaire administration
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Procedure: management of therapy complications
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Adverse event profile of a topical menadione-containing lotion
[Time Frame: 8 weeks]
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Long-term cutaneous and psychosocial discomfort and adverse event
[Time Frame: 4 weeks]
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Secondary ID(s)
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MC10C9
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NCI-2011-01047
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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