Study of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline in Treating Skin Irritation From Radiation
This trial is active, not recruiting.
|Start date||October 2012|
|End date||October 2015|
|Trial size||30 participants|
|Trial identifier||NCT01714973, ST-02-12|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Adverse Events (AEs) and Significant Adverse Events (SAEs)
time frame: Start of therapy through six week follow-up visit
time frame: start of therapy through six week follow-up visit
Quality of life
time frame: start of therapy through one year follow-up
Female participants from 18 years up to 80 years old.
- 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.
- 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
|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|
|Principal investigator||Mark Trombetta, MD|
Call for more information