Alkagin Paste in the Prevention of Radiation Dermatitis

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2014

Interventions

  • Other: Aveeno cream
    • Apply cream on irradiated area twice a day
  • Other: Alkagin paste
    • Apply Alkagin paste three times a day.

Arms, Groups and Cohorts

  • 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
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Maximum skin toxicity
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr. Te Vuong
  • Collaborator
    • Avario Healthcare Inc.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr. Te Vuong, MD-Director Radiation Oncology – Sir Mortimer B. Davis – Jewish General Hospital
  • Overall Official(s)
    • Te Vuong, MD, Principal Investigator, Jewish General Hospital

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