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

NCT ID: NCT01923220

Last Updated: 2013-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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Breast Cancer Radiation Therapy Radiation Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HO/02/02

Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily

Group Type EXPERIMENTAL

HO/02/02 20µg

Intervention Type DRUG

Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily

Aloe Vera Jel

To be applied topically

Group Type SHAM_COMPARATOR

Aloe Vera Jel

Intervention Type OTHER

To be applied topically once daily

Interventions

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HO/02/02 20µg

Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily

Intervention Type DRUG

Aloe Vera Jel

To be applied topically once daily

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HealOr

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yair Alegranti

Role: STUDY_DIRECTOR

HealOr

Locations

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The Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yair Alegranti

Role: CONTACT

Phone: +972-8-9407188

Email: [email protected]

Kira Olshvang

Role: CONTACT

Phone: +972-8-9407188

Email: [email protected]

Facility Contacts

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Ilanit Dromi

Role: primary

Other Identifiers

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HO-ARD-01-2012

Identifier Type: -

Identifier Source: org_study_id