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KeraStat Skin Therapy in Treating Radiation Dermatitis in Patients With Newly Diagnosed Stage 0-IIIA Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT02168179
First received: June 18, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy may be a better treatment for radiation dermatitis.


Condition Intervention
Ductal Breast Carcinoma in Situ
Skin Reactions Secondary to Radiation Therapy
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Procedure: dermatologic complications management/prevention
Other: questionnaire administration

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety of Treatment With KeraStat Skin Therapy in Breast Cancer Patients Developing Radiation Dermatitis

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Occurrence of any RT-induced EASR defined as a grade 4 or higher toxicity using the Modified Oncology Nursing Society Criteria for Radiation-Induced Acute Skin Toxicity [ Time Frame: Up to 2 months after completion of radiation therapy ] [ Designated as safety issue: Yes ]
    At each time point the proportion of women who have RT-induced EASR present will be estimated and a 95% confidence interval will be calculated around this estimate.


Other Outcome Measures:
  • Categorical confounders, such as race/ethnicity, age, hormone therapy, smoking history/status, diabetes, high blood pressure, breast size, RT characteristics, and RT dosimetry characteristics, using the Baseline Study Risk Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A series of 2xr tables will be examined to determine the relationship between each of the categorical confounders and the primary endpoint. Chi-squared statistics will be estimated for each of these tables to give some preliminary descriptive data to identify potential variables that may be associated with the primary outcome.


Estimated Enrollment: 20
Study Start Date: July 2014
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive Care (KeraStat Skin Therapy)
Patients apply KeraStat Skin Therapy topically BID during radiation therapy.
Procedure: dermatologic complications management/prevention
Apply KeraStat Skin Therapy topically
Other Names:
  • complications management/prevention, dermatologic
  • management/prevention, dermatologic complications
Other: questionnaire administration
Ancillary studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To obtain a preliminary estimate the incidence of early adverse skin reaction (EASR) during radiation therapy (RT) and up to two months post RT after the application of the cosmetic cream KeraStat Skin Therapy during RT in breast cancer patients in a pilot study.

SECONDARY OBJECTIVES:

I. To associate personal characteristics (e.g., race/ethnicity, age, hormone therapy, smoking status, comorbidities, breast size) and treatment characteristics (e.g., RT dose) to incidence of EASR at any time point.

OUTLINE:

Patients apply KeraStat Skin Therapy topically twice daily (BID) during radiation therapy.

After completion of study treatment, patients are followed up at 1 and 2 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed with breast carcinoma, stage 0-IIIA (including ductal carcinoma in situ [DCIS])
  • Status post-lumpectomy, -quadrantectomy, or -mastectomy
  • Plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes
  • Total dose >= 40Gy
  • Dose per fraction >= 1.8 use of 2-dimensional (2D), 3-dimensional (3D) conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; skin sparing IMRT patients excluded; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens
  • Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
  • Adjuvant hormonal therapy will be allowed prior to, during and/or after RT at the discretion of a medical oncologist
  • Targeted therapies such as Herceptin will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist
  • Patients who are able and willing to sign protocol consent form

Exclusion Criteria:

  • Prior radiation to the involved breast or chest wall
  • Concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion)
  • Patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed)
  • Patients undergoing partial breast irradiation
  • Patients who have undergone MammoSite® or any other form of brachytherapy
  • Patients may not be concurrently enrolled in a protocol that involves treatment of the skin ie: applying lotions /moisturizers; protocols that do not involve treatment of the skin are allowed
  • Patients who are pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02168179

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Arthur W. Blackstock    336-713-6501    ablackst@wakehealth.edu   
Principal Investigator: Arthur W. Blackstock         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Arthur Blackstock Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT02168179     History of Changes
Other Study ID Numbers: CCCWFU 98114, NCI-2014-01274, CCCWFU 98114, P30CA012197
Study First Received: June 18, 2014
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Dermatitis
Radiodermatitis
Adenocarcinoma
Breast Diseases
Carcinoma
Carcinoma, Ductal
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Radiation Injuries
Skin Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014