A Phase 3 interventional study of sunscreen and placebo in Dermatologic Complications and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Alliance for Clinical Trials in Oncology. Completed at 208 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-13.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care
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:
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.
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.
79 studies on the registry are indexed under Exanthema; 12 are open to participants now.
This study's enrollment of 116 is above the median of 42 across 58 interventional studies indexed under Exanthema.
Browse Exanthema studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Receiving ≥ 1 of the following epidermal growth factor receptor (EGFR) inhibitor treatments:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
Drug: sunscreen
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.
Other: placebo
Incidence and severity of rash development by Skindex questionnaire
Time frame: Up to 8 weeks
Toxicity by NCI CTCAE v3.0
Time frame: Up to 8 weeks
Rash incidence at 4 and 8 weeks
Time frame: Up to 8 weeks
Showing the first 100 of 208 sites.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology