Alkagin Paste in the Prevention of Radiation Dermatitis
This study is currently recruiting participants.
Verified May 2013 by Sir Mortimer B. Davis - Jewish General Hospital
Sponsor:
Dr. Te Vuong
Collaborator:
Avario Healthcare Inc.
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01408407
First received: August 2, 2011
Last updated: May 7, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anus Neoplasms Rectal Neoplasms Urogenital Neoplasms |
Other: Aveeno cream Other: Alkagin paste |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase II Study Designed to Evaluate the Value of Alkagin Paste in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy |
Resource links provided by NLM:
Further study details as provided by Sir Mortimer B. Davis - Jewish General Hospital:
Primary Outcome Measures:
- Maximum skin toxicity [ Time Frame: 7 weeks post beginning of radiation treatments ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm A: standard of care
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
Apply cream on irradiated area twice a day
|
|
Experimental: Arm B: standard of care plus Alkagin paste
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
Apply cream on irradiated area twice a day
Other: Alkagin paste
Apply Alkagin paste three times a day.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408407
Contacts
| Contact: Chantal Cadieux, PhD | 1-514-340-8222 ext 6199 | ccadieux@jgh.mcgill.ca |
Locations
| Canada, Quebec | |
| Jewish General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
Sponsors and Collaborators
Dr. Te Vuong
Avario Healthcare Inc.
Investigators
| Principal Investigator: | Te Vuong, MD | Jewish General Hospital |
More Information
No publications provided
| Responsible Party: | Dr. Te Vuong, MD-Director Radiation Oncology, Sir Mortimer B. Davis - Jewish General Hospital |
| ClinicalTrials.gov Identifier: | NCT01408407 History of Changes |
| Other Study ID Numbers: | 11-052 |
| Study First Received: | August 2, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Canada: Research Ethics Office |
Keywords provided by Sir Mortimer B. Davis - Jewish General Hospital:
|
Patients with anal canal, low rectal or gynecological cancer |
Additional relevant MeSH terms:
|
Anus Neoplasms Neoplasms Dermatitis Radiodermatitis Rectal Neoplasms Urogenital Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases Skin Diseases Radiation Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013