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

Breast Cancer Clinical Trial

— ARD  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01923220
• Other study ID #: HO-ARD-01-2012
• Status: Not yet recruiting
• Phase: Phase 0
• First received: August 12, 2013
• Last updated: August 12, 2013
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: HealOr
• Contact: Yair Alegranti
• Phone: +972-8-9407188
• Email: yair[@]healor.com
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Dermatitis
• Radiodermatitis

Intervention

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

Other:
• Aloe Vera Jel
To be applied topically once daily

Locations

Country	Name	City	State
Israel	The Chaim Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
HealOr

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Frequency and severity of adverse events reported by the patients and assessed clinically by NCI CTC v2.0		62 Days	No