A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Topical Sunscreen to Prevent Erlotinib- or Cetuximab-Induced Skin Rash [or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash]
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 116
- Locations
- 205
- Primary Endpoint
- Incidence and severity of rash development by Skindex questionnaire
Study Overview
Brief Summary
RATIONALE: Topical sunscreen may be effective in preventing skin rash caused by treatment with drugs such as erlotinib or cetuximab. It is not yet known whether topical sunscreen is more effective than a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.
PURPOSE: This randomized phase III trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.
Detailed Description
OBJECTIVES:
- Compare the incidence and severity of erlotinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo.
- Determine the toxicity of topical sunscreen vs placebo in these patients.
- Determine whether discontinuation of treatment intervention is followed by rash development.
OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified according to chemotherapy regimen (first-line chemotherapy vs other), epidermal growth factor receptor (EGFR) inhibitor therapy (small molecule vs monoclonal antibodies), concurrent medication that increases sun hypersensitivity (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients apply sunscreen generously to the entire body twice daily for 4 weeks.
- Arm I: Patients apply placebo generously to the entire body twice daily for 4 weeks.
Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
sunscreen
Patients apply sunscreen generously to the entire body twice daily for 4 weeks.
Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks.
After completion of study treatment, patients are followed for 8 weeks.
Intervention: sunscreen (Drug)
placebo
Patients apply placebo generously to the entire body twice daily for 4 weeks.
Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks.
After completion of study treatment, patients are followed for 8 weeks.
Intervention: placebo (Other)
Outcomes
Primary Outcomes
Incidence and severity of rash development by Skindex questionnaire
Time Frame: Up to 8 weeks
Secondary Outcomes
- Toxicity by NCI CTCAE v3.0(Up to 8 weeks)
- Rash incidence at 4 and 8 weeks(Up to 8 weeks)