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

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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

Trial contacts and locations

1

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Central trial contact

Yair Alegranti; Kira Olshvang

Data sourced from clinicaltrials.gov

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