The Role of Calcipotriol as Radioprotector of Skin

Radiodermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00445250
• Other study ID #: 004253
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 7, 2007
• Last updated: March 7, 2007

Study information

• Verified date: January 2007
• Source: Rabin Medical Center
• Contact: Eyal Fenig, M.D.
• Phone: 97239377964
• Email: efenig[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radiodermatitis

Intervention

Drug:
• Calcipotriol

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tiqva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of radiodermatitis
Secondary	Side effects of Calcipotriol