Status:
UNKNOWN
PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis
Lead Sponsor:
Pharm Olam Pharmaceuticals Ltd.
Conditions:
Prevention of Radiation Induced Dermatitis.
Eligibility:
FEMALE
18-65 years
Brief Summary
A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.
Eligibility Criteria
Inclusion
- Female patients at least 18 years with unilateral breast cancer following lumpectomy +/- chemotherapy.
- Planned to receive 50 Gy whole breast irradiation +/- boost to tumor bed.
- ECOG PERFORMANCE STATUS 0-1.
- Capable of giving written informed consent and following instructions for applying study emulsion or placebo as per control.
- No co-morbidities known to affect radiotherapy reactions.
- No co-existing acute or chronic skin disease.
- No evidence of infection or inflammation of breast to be treated.
- Not receiving chemotherapy during radiotherapy course.Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study.
Exclusion
- Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation.
- Prior radiotherapy to any site.
- Collagen vascular disease.
- Diabetes mellitus requiring medication.
- Uncontrolled hypertension.
- Participation in other clinical study.
- Any contra-indicating to treatment with Melatonin.
- History of allergy to peanuts or fragrances.
- History of severe allergic reactions (e.g. asthma).
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00840515
Start Date
February 1 2009
End Date
August 1 2009
Last Update
May 6 2009
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