Alkagin Paste in the Prevention of Radiation Dermatitis

This study is currently recruiting participants.
Verified September 2013 by Sir Mortimer B. Davis - Jewish General Hospital
Sponsor:
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: September 26, 2013
Last verified: September 2013
  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 2015
Estimated Primary Completion Date: December 2014 (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: September 26, 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:
Rectal Neoplasms
Anus Neoplasms
Neoplasms
Dermatitis
Radiodermatitis
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 April 14, 2014