Alkagin Paste in the Prevention of Radiation Dermatitis (NCT01408407) | Clinical Trial Compass
TerminatedPhase 2
Alkagin Paste in the Prevention of Radiation Dermatitis
Canada2 participantsStarted 2011-12
Plain-language 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.
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.
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
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
1
Maximum skin toxicity
Timeframe: 7 weeks post beginning of radiation treatments
Trial details
NCT IDNCT01408407
SponsorSir Mortimer B. Davis - Jewish General Hospital