NCT02168179

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

June 18, 2014

Last Update Submit

July 2, 2018

Conditions

Ductal Breast Carcinoma in SituSkin Reactions Secondary to Radiation TherapyStage IA Breast CancerStage IB Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    Up to 2 months after completion of radiation therapy

Other Outcomes (1)

  • 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

    Baseline

Study Arms (1)

Supportive Care (KeraStat Skin Therapy)

EXPERIMENTAL

Patients apply KeraStat Skin Therapy topically BID during radiation therapy.

Procedure: dermatologic complications management/preventionOther: questionnaire administration

Interventions

dermatologic complications management/preventionPROCEDURE

Apply KeraStat Skin Therapy topically

Also known as: complications management/prevention, dermatologic, management/prevention, dermatologic complications
Supportive Care (KeraStat Skin Therapy)
questionnaire administrationOTHER

Ancillary studies

Supportive Care (KeraStat Skin Therapy)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, NoninfiltratingBreast Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Arthur Blackstock

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

December 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(1)