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Phase I Randomized, Blinded Safety and Efficacy Trial of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline Sprayed on the Breast of Women Undergoing Radiation Therapy for Breast Cancer After Surgical Removal of the Tumor


Phase 1
18 Years
80 Years
Open (Enrolling)
Female
Radiation-induced Dermatitis

Thank you

Trial Information

Phase I Randomized, Blinded Safety and Efficacy Trial of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline Sprayed on the Breast of Women Undergoing Radiation Therapy for Breast Cancer After Surgical Removal of the Tumor


Inclusion Criteria:



- A signed IRB - approved Informed Consent;

- Women 18 - 80 years of age;

- Biopsy-proven diagnosis of breast cancer with the tumor surgically removed.

- Whole breast radiation with or without ipsilateral axilla radiation therapy
recommended by her radiation oncologist.

- If a woman is of child-bearing potential, she and her partner must use an effective
form of birth control.

- Willing to participate in the clinical study and comply with the requirements of the
trial.

Exclusion Criteria:

- Abnormal liver or kidney function studies being greater than 2x the upper limit of
normal.

- Patients on hemodialysis

- Psychiatric condition or substance abuse which in the Investigator's opinion may pose
a threat to patient compliance;

- History of non-compliance with treatment or clinical visit attendance.

- Participation in an investigational trial within 30 days of study entry.

- Women who are pregnant or lactating

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Adverse Events (AEs) and Significant Adverse Events (SAEs)

Outcome Time Frame:

Start of therapy through six week follow-up visit

Safety Issue:

No

Principal Investigator

Mark Trombetta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Penn Allegheny Health System

Authority:

United States: Institutional Review Board (IRB)

Study ID:

ST-02-12

NCT ID:

NCT01714973

Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Radiation-induced Dermatitis
  • Dermatitis
  • Radiodermatitis

Name

Location
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772