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

Sponsor

HealOr (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01923220

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: HO/02/02 20µg Other: Aloe Vera Jel	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Sep 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Frequency and severity of adverse events reported by the patients and assessed clinically by NCI CTC v2.0 [62 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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