Anus Neoplasms, Rectal Neoplasms, Urogenital Neoplasms
Conditions
Keywords
Patients with anal canal, low rectal or gynecological cancer
Brief summary
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.
Interventions
OTHERAveeno cream
Apply cream on irradiated area twice a day
OTHERAlkagin paste
Apply Alkagin paste three times a day.
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Avario Healthcare Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum skin toxicity | 7 weeks post beginning of radiation treatments | 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORTe Vuong, MD
Jewish General Hospital
Outcome results
None listed