MediHoney for Radiation Dermatitis

NCT02234479 | Completed Results DMC

• 1 other identifier: HP-00058645
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.

Conditions

Breast Cancer; Radiation Dermatitis

Keywords

Breast Cancer; Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy

  The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.

  12 months

Study Arms (2)

Hydrophor (Group A)

ACTIVE COMPARATOR

Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

Biological: Hydrophor (Group A)

MediHoney (Group B)

EXPERIMENTAL

Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.

Biological: MediHoney (Group B)

Interventions

Hydrophor (Group A) BIOLOGICAL

* Rehydrates dry, chapped or chafed skin * May be used alone as a skin lubricant or protectant

Hydrophor (Group A)

MediHoney (Group B) BIOLOGICAL

It helps the body's natural healing processes in three key ways which have been shown to have healing benefits: * Maintain a balanced environment for healing. * Aids in reducing dermatitis. * Reduce affected area pH.2-3

MediHoney (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer treated with either lumpectomy or mastectomy (with or without reconstruction).
• The patient must be female.
• Radiation therapy planned to whole breast/chestwall area (can include lymph node radiation; conventional 3D radiation, IMRT/IGRT, and hypofractionation are all allowed).
• Age ≥ 18 years old.

You may not qualify if:

• Previous radiation therapy to chest area that would result in overlapping radiation fields.
• Wound care issues.
• Patients undergoing concurrent cytotoxic chemotherapy and radiation therapy (concurrent Herceptin and/or tamoxifen/aromatase inhibitors and RT is allowed).
• Patients receiving HDR (savi or mammosite) brachytherapy treatments.
• Patients with an allergy and/or sensitivity to Hydrophor, honey, and/or Medihoney.
• Immunocompromised status.
• Age \< 18 years old.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Results Point of Contact

• Title: Elizabeth Nichols, MD
• Organization: University of Maryland

enichols1@umm.edu

410-328-2324

Study Officials

• Elizabeth Nichols, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 9, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 18, 2020
• Results First Posted: August 8, 2016

Record last verified: 2020-03

Locations

US (1)