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

NCT01923220 | Unknown Early Phase 1

• 1 other identifier: HO-ARD-01-2012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast Cancer; Radiation Therapy; Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  62 days

Secondary Outcomes (1)

• Frequency and severity of adverse events reported by the patients and assessed clinically by NCI CTC v2.0

  62 Days

Study Arms (2)

HO/02/02

EXPERIMENTAL

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

Drug: HO/02/02 20µg

Aloe Vera Jel

SHAM COMPARATOR

To be applied topically

Other: Aloe Vera Jel

Interventions

HO/02/02 20µg DRUG

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

HO/02/02

Aloe Vera Jel OTHER

To be applied topically once daily

Aloe Vera Jel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealOr: lead

Study Sites (1)

The Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Study Officials

• Yair Alegranti

  HealOr

  STUDY DIRECTOR

Central Study Contacts

Yair Alegranti

CONTACT

+972-8-9407188; yair@healor.com

Kira Olshvang

CONTACT

+972-8-9407188; kira@healor.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 15, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

IL (1)