The Role of Calcipotriol as Radioprotector of Skin

March 7, 2007 updated by: Rabin Medical Center

Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast.

Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast.

To check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus, use of medications, allergies, weight, habits, size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

STUDY PROTOCOL

Fifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy, will participate in the study. About 15 minutes after receiving the daily radiation dose fraction, a cream containing an active vitamin D analogue will be applied to half of the breast with inspection of a nurse. The other half of the breast will have a standard cream applied . During the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy (e.g. strong erythema, painful tenderness etc.)The adverse skin effects will be assessed according to the following criteria:

  1. . an assessment by a physician and a nurse according to the RTOG score (6).

    As follows:

    Grade 0 - no reaction. Grade 1 - light erythema dry peeling, decrease in sweat production. Grade 3 - extensive moist peeling, pitting edema. Grade 4 - ulcers, bleeding and necrosis.

  2. . A questionnaire to each patient regarding the efficacy and safety of the cream.
  3. . Number of interruption of radiotherapy treatment. The assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment.

Safety report will be sent to the local independent ethics committee after the examination of the first ten patients.

The protective effect of the cream containing calcipotriol will be compared to the standard treatment and analyzed statistically using the parameters mention above. The relation between the background disease, medications, allergies, weight, habits, size of the irradiated breast, sun exposure, previous chemotherapy treatment and exposure to sunlight and the skin reaction will be evaluated.

INCLUSION CRITERIA

  1. . Age ranging from 18 to 75.
  2. . Confirmed histological diagnosis of Breast cancer.
  3. . Radiotherapy treatment to the breast following lumpectomy.

EXCLUSION CRITERIA

  1. . Scleroderma.
  2. . An extremely large breast. Interfiled above 25 cm.
  3. . Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.
  4. . Mastectomy.

Study Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petach Tiqva, Israel, 49100
        • Rabin Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eyal Fenig, M.D.
        • Sub-Investigator:
          • Ofer Purim, M.D.
        • Sub-Investigator:
          • Amir Abramovich, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age ranging from 18 to 75.
  2. Confirmed histological diagnosis of Breast cancer.
  3. Radiotherapy treatment to the breast following lumpectomy.

Exclusion Criteria:

  1. Scleroderma.
  2. An extremely large breast. Interfiled above 25 cm.
  3. Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.
  4. Mastectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prevention of radiodermatitis

Secondary Outcome Measures

Outcome Measure
Side effects of Calcipotriol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Eyal Fenig, M.D., Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

March 8, 2007

Last Update Submitted That Met QC Criteria

March 7, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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