CompletedPhase 3

Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer

United States116 participantsStarted 2006-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of cancer * Receiving ≥ 1 of the following epidermal growth factor receptor (EGFR) inhibitor treatments: * Gefitinib * Cetuximab * Erlotinib * Panitumumab * ICR-62 * Matuzumab * CI-1033 * EGFR treatment must have begun within the past 3 days * No rash (of any etiology) at study entry PATIENT CHARACTERISTICS: * Able to apply sunscreen on face, trunk, and extremities * Able to complete questionnaire(s) * No history of allergic reactions or severe intolerance to sunscreen or its derivatives * No history of skin problems likely to reoccur during treatment * Must avoid heavy sun exposure, especially during the hours of noon to 4 pm daily PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent tanning bed usage * No other concurrent topical sunscreens

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and severity of rash development by Skindex questionnaire

Timeframe: Up to 8 weeks

Trial details

NCT IDNCT00362986

SponsorAlliance for Clinical Trials in Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-07

View on ClinicalTrials.gov More Dermatologic Complications trials