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Alkagin Paste in the Prevention of Radiation Dermatitis

Primary Purpose

Anus Neoplasms, Rectal Neoplasms, Urogenital Neoplasms

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Aveeno cream
Alkagin paste
Sponsored by
Dr. Te Vuong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anus Neoplasms focused on measuring Patients with anal canal, low rectal or gynecological cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: standard of care

Arm B: standard of care plus Alkagin paste

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2011
Last Updated
May 22, 2015
Sponsor
Dr. Te Vuong
Collaborators
Avario Healthcare Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01408407
Brief Title
Alkagin Paste in the Prevention of Radiation Dermatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Te Vuong
Collaborators
Avario Healthcare Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anus Neoplasms, Rectal Neoplasms, Urogenital Neoplasms
Keywords
Patients with anal canal, low rectal or gynecological cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: standard of care
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm B: standard of care plus Alkagin paste
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aveeno cream
Intervention Description
Apply cream on irradiated area twice a day
Intervention Type
Other
Intervention Name(s)
Alkagin paste
Intervention Description
Apply Alkagin paste three times a day.
Primary Outcome Measure Information:
Title
Maximum skin toxicity
Description
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.
Time Frame
7 weeks post beginning of radiation treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Te Vuong, MD
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

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Alkagin Paste in the Prevention of Radiation Dermatitis

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