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

HealOr

Status and phase: Unknown; Early Phase 1

Conditions: Breast Cancer

Treatments: Drug: HO/02/02 20µg; Other: Aloe Vera Jel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01923220

HO-ARD-01-2012

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

HO/02/02

Experimental group

Description:

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

Treatment:

Drug: HO/02/02 20µg

Aloe Vera Jel

Sham Comparator group

Description:

To be applied topically

Treatment:

Other: Aloe Vera Jel