Study of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline in Treating Skin Irritation From Radiation
The objective of this study is to evaluate the safety and efficacy of ACCS in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ACCS treated burns with those treated with saline placebo controls.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Adverse Events (AEs) and Significant Adverse Events (SAEs) [ Time Frame: Start of therapy through six week follow-up visit ] [ Designated as safety issue: No ]
- Skin inflammation [ Time Frame: start of therapy through six week follow-up visit ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: start of therapy through one year follow-up ] [ Designated as safety issue: No ]
- Cosmesis [ Time Frame: 6 and 12 months post-treatment ] [ Designated as safety issue: No ]Cosmesis will be evaluated by photography and investigator assessment using the cosmesis form in National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-39, A Randomized Phase III Study of Conventional Whole Breast Irradiation Versus Partial Breast Irradiation for Women with Stage 0, I, or II Breast Cancer. The following factors will be evaluated in the skin: telangiectasia, atrophy, scarring, pigmentation, erythema, fat necrosis, and fibrosis.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
There will be 3 treatment cohorts of 10 patients each. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The patient will be randomized before the first treatment to receive ACCS and saline, one to the medial segment and the other to the lateral segment. The randomization scheme will be equal in each of three cohorts. The first cohort will receive ACCS and saline beginning with the first radiation treatment, the second cohort will receive ACCS and saline beginning with the onset of erythema from the breast irradiation, the third cohort will receive ACCS and saline beginning with the onset of skin ulceration from the breast irradiation.
Patients will receive ACCS spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments. ACCS and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.
Other Name: Amnion-derived Cellular Cytokine Solution (ACCS)
|Contact: David L Steed, MDfirstname.lastname@example.org|
|Contact: Nia Tatsis, PhDemail@example.com|
|United States, Pennsylvania|
|Allegheny General Hospital||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15212|
|Contact: Susan Hebda, BS, CCRC 412-359-4046 firstname.lastname@example.org|
|Principal Investigator:||Mark Trombetta, MD||West Penn Allegheny Health System|
|Study Director:||David L Steed, MD||Stemnion, Inc.|