Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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]
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.
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.
After completion of study treatment, patients are followed for 8 weeks.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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