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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealOr

Criteria

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