NCT00445250

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
Last Updated

March 8, 2007

Status Verified

January 1, 2007

First QC Date

March 7, 2007

Last Update Submit

March 7, 2007

Conditions

Radiodermatitis

Keywords

CalcipotriolBreastCancerRadiotherapyRadiodermatitis in Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Prevention of radiodermatitis

Secondary Outcomes (1)

  • Side effects of Calcipotriol

Interventions

CalcipotriolDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petach Tiqva, 49100, Israel

Location

MeSH Terms

Conditions

RadiodermatitisNeoplasms

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and Injuries

Study Officials

  • Eyal Fenig, M.D.

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Fenig, M.D.

CONTACT

97239377964efenig@clalit.org.il

Ofer Purim, M.D.

CONTACT

97239377973oferp@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 8, 2007

Last Updated

March 8, 2007

Record last verified: 2007-01

Locations

IL(1)