Alkagin Paste in the Prevention of Radiation Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Alkagin paste is effective at preventing radiodermatitis in patients receiving external beam radiation therapy to the perineal area.

Official Title
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A Phase II Study Designed to Evaluate the Value of Alkagin Paste in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy

Conditions
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Anus Neoplasms, Rectal Neoplasms, Urogenital Neoplasms

Intervention / Treatment
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* Other: Aveeno cream
* Other: Alkagin paste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving a dose of 45 Gy or more with concomitant chemotherapy to the perineal skin (for treatment of anal canal, low rectal or gynecological cancer). Patients able to understand and sign an informed consent form. Patients that do not have active connective tissue disorders. Patients 18 years or older. Patients that did not receive any previous radiation. Patients that do not have any known allergy to any ingredients of the Alkagin Paste Patients need to be able to apply the creams themselves or have help with applying the creams. Patients who have been offered to purchase silver clear underpants but have refused Exclusion Criteria: Patients that have a type V or type VI skin type according to the Fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it) The Fitzpatrick Scale: Type I (scores 0-7) White; very fair; freckles. Always burns, never tans Type II (scores 8-16) White; fair. Usually burns, tans with difficulty Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin. Rarely burns, tans with ease Type V (scores over 30) Dark brown. Very rarely burns, tans very easily Type VI Black. Never burns, tans very easily 2) Patients with an allergic reaction to Alkagin Paste

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: standard of care<br>Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatment | Other: Aveeno cream<br>* Apply cream on irradiated area twice a day<br>|
| Experimental: Arm B: standard of care plus Alkagin paste<br>Patients will apply Alkagin Paste to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. They will also perform standard of care skin treatment. | Other: Aveeno cream<br>* Apply cream on irradiated area twice a day<br>Other: Alkagin paste<br>* Apply Alkagin paste three times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum skin toxicity | The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of Alkagin Paste compared to patients treated with institutional standard skin care. | 7 weeks post beginning of radiation treatments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with anal canal, low rectal or gynecological cancer