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A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer

Sponsor
Water-Jel (Industry)
Overall Status
Terminated
CT.gov ID
NCT01597921
Collaborator
(none)
50
Enrollment
1
Location
7
Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All women will be given two types of Jell. One should be applied immediately after radiation and the second one, 3 times every day. All women will complete detailed questionnaire every two weeks and will be evaluated by the treating team at the same time.All women will be evaluated two weeks after end of radiation period.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Phase II, Double Blinded, Randomized Study of R1 and R2 (Waterjel) Verses Aloe Vera Jell for the Prevention and Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
    Study Start Date :
    May 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2012
    Anticipated Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Breast cancer patient receiving RT

    Total dose:2Gy/Fx

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      1. Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy.

      2. Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy.

      3. Patient able to understand the study designed and cooperate with instructions of use.

      4. Patient able to sign informed consent

      Exclusion Criteria:

      1. Woman with lactose allergy (lactose intolerance are eligible)

      2. Woman with known connective tissue disorder

      3. Woman with uncontrolled diabetes

      4. Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx

      5. Woman who is unable to sign an informed consent

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Sheba Medical Center Ramat-Gan Israel 55555

      Sponsors and Collaborators

      • Water-Jel

      Investigators

      • Principal Investigator: Merav Ben David, La Sheba Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Dr Merav Ben-David, Dr, Water-Jel
      ClinicalTrials.gov Identifier:
      NCT01597921
      Other Study ID Numbers:
      • 23267384
      First Posted:
      May 14, 2012
      Last Update Posted:
      Aug 9, 2012
      Last Verified:
      Aug 1, 2012
      Keywords provided by Dr Merav Ben-David, Dr, Water-Jel
      Breast conserving surgery
      Radiation dermatitis
      Additional relevant MeSH terms:
      Breast Neoplasms
      Dermatitis
      Erythema
      Radiodermatitis

      Study Results

      No Results Posted as of Aug 9, 2012