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

Not Applicable

Withdrawn

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

• Registration Number: NCT02168179
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-20
• Study Start: 2014-12
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (KeraStat Skin Therapy)	questionnaire administration	Patients apply KeraStat Skin Therapy topically BID during radiation therapy.
Supportive Care (KeraStat Skin Therapy)	dermatologic complications management/prevention	Patients apply KeraStat Skin Therapy topically BID during radiation therapy.

Primary Outcome Measures

Name	Time	Method
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	Up to 2 months after completion of radiation therapy	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.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States