Study of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline in Treating Skin Irritation From Radiation
|ClinicalTrials.gov Identifier: NCT01714973|
Recruitment Status : Unknown
Verified January 2015 by Noveome Biotherapeutics, formerly Stemnion.
Recruitment status was: Active, not recruiting
First Posted : October 26, 2012
Last Update Posted : January 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Radiation-induced Dermatitis||Biological: ACCS||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
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)
- Adverse Events (AEs) and Significant Adverse Events (SAEs) [ Time Frame: Start of therapy through six week follow-up visit ]
- Skin inflammation [ Time Frame: start of therapy through six week follow-up visit ]
- Quality of life [ Time Frame: start of therapy through one year follow-up ]
- Cosmesis [ Time Frame: 6 and 12 months post-treatment ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714973
|United States, Pennsylvania|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212|
|Principal Investigator:||Mark Trombetta, MD||West Penn Allegheny Health System|
|Study Director:||David L Steed, MD||Noveome Biotherapeutics, formerly Stemnion|