The Role of Calcipotriol as Radioprotector of Skin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00445250
First received: March 7, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Radiodermatitis
Drug: Calcipotriol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Prevention of radiodermatitis

Secondary Outcome Measures:
  • Side effects of Calcipotriol

Estimated Enrollment: 50
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445250

Contacts
Contact: Eyal Fenig, M.D. 97239377964 efenig@clalit.org.il
Contact: Ofer Purim, M.D. 97239377973 oferp@clalit.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petach Tiqva, Israel, 49100
Contact: Eyal Fenig, M.D.    97239377964    efenig@clalit.org.il   
Contact: Ofer Purim, M.D.    97239377973    oferp@clalit.org.il   
Principal Investigator: Eyal Fenig, M.D.         
Sub-Investigator: Ofer Purim, M.D.         
Sub-Investigator: Amir Abramovich, M.D.         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Eyal Fenig, M.D. Rabin Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00445250     History of Changes
Other Study ID Numbers: 004253
Study First Received: March 7, 2007
Last Updated: March 7, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Calcipotriol
Breast
Cancer
Radiotherapy
Radiodermatitis in Breast Cancer

Additional relevant MeSH terms:
Radiodermatitis
Dermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries
Calcipotriene
Calcitriol
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014