Clinical trial NCT01393821: Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatologic Complications
Malignant Neoplasm
Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-07-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort
timeFrame: From Baseline to Week 4
Secondary outcomes:
measure: The Number of Patients Experiencing Worst Toxicity
timeFrame: Up to 8 weeks
measure: Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)
timeFrame: Baseline, 4 weeks
measure: Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Campus in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, M.D.
role: STUDY_CHAIR
References: