Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis (ARD)

August 12, 2013 updated by: HealOr

An Open-Label, Randomized Study to Evaluate the Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis In Breast Cancer Patients Undergoing Radiation Therapy.

This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment in addition to sterile water for irrigation applied daily for 15 minutes (with gauze) on treatment fields to create the same cooling effect as in treatment arm 1. Both treatment arms 1&2 treatments will be applied topically once daily for up to 8 weeks to reduce radiation dermatitis in up to 90 breast cancer patients undergoing adjuvant radiation therapy.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Early Phase 1

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

  • Name: Yair Alegranti
  • Phone Number: 122 +972-8-9407188
  • Email: yair@healor.com

Study Contact Backup

  • Name: Kira Olshvang
  • Phone Number: 117 +972-8-9407188
  • Email: kira@healor.com

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • The Chaim Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Merav Ben-David, 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients 18 years old and above.
  • Histology confirmed unilateral breast cancer following lumpectomy
  • Planned to receive 50 Gy, whole breast XRT and regional lymph nodes radiation.
  • ECOG performance status 0-2
  • Completed Chemotherapy 3 weeks prior to XRT (if applicable)
  • Patient should be available for the entire study period, and be able and willing to adhere to protocol requirements;
  • Patient must sign an informed consent form prior to undergoing any study-related procedures

Exclusion Criteria:

  • Known uncontrolled diabetes
  • Prior radiation to breast
  • Known connective tissue disorder
  • Known skin disease over the treated breast
  • Prior burn over treated area
  • Evidence of infection or inflammation of breast to be treated.
  • Receiving biological therapy or hormone therapy (other than Herceptin) during radiation treatment/study duration and 4 weeks prior to study entry.
  • Pre-existing skin breakdown within the planned radiotherapy field at the time of study entry.
  • Pregnancy, planned pregnancy, lactation or inadequate contraception as judged by the Investigator.
  • Participation in another investigational drug or vaccine trial concurrently or within 30 days.
  • Use of any other topical or systemic treatments aimed at radiation dermatitis.
  • Use of a prescription or over-the-counter medication that contains hydrocortisone or any other cortisone or corticosteroid containing preparation

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HO/02/02
Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily
Drug: HO/02/02 20µg
Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily
Sham Comparator: Aloe Vera Jel
To be applied topically
Other: Aloe Vera Jel
To be applied topically once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients using HO/02/02 20µg that developed grade 1-4 radiation dermatitis during adjuvant radiation therapy for breast cancer compared to SoC (Aloe Vera) commonly used as standard of care treatment.
Time Frame: 62 days
62 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and severity of adverse events reported by the patients and assessed clinically by NCI CTC v2.0
Time Frame: 62 Days
62 Days

Collaborators and Investigators

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

Sponsor

HealOr

Investigators

  • Study Director: Yair Alegranti, HealOr

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 Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 15, 2013

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HO-ARD-01-2012

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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