Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

Noveome Biotherapeutics, formerly Stemnion20 enrolled

Overview

The objective of this study is to evaluate the safety and efficacy of ST266 in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ST266 treated burns with those treated with saline placebo controls.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Radiation-induced Dermatitis

Interventions

ST266BIOLOGICAL

Patients will receive ST266 spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments. ST266 and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: Start of therapy through six week follow-up visit

Secondary Outcomes

Skin inflammation

Time frame: start of therapy through six week follow-up visit

Quality of Life (QOL)scaled responses

Quality of Life (QOL) will be evaluated using a QOL Assessment (general to breast cancer patients receiving radiation therapy following tumor removal) and a QOL Supplement (specific to subjects receiving trial treatment). Both documents include subsets of questions, each with a different subscale. The assessments include both lifestyle QOL factors (sleep, activity, friends/family, general life enjoyment, etc.) and breast condition (pain, appearance, ect.). This secondary endpoint will focus on the QOL Supplement, comparing breast condition by treatment, noting changes in both the medial and lateral aspects breast including breast texture (thickening and hardness), pain, tenderness, shape, sensitivity, swelling, redness, itching, flaking skin, blistering and fluid leak. The patient will note, for each item, in which side of the breast they are experiencing the negative breast condition or if there is no difference.

Time frame: start of therapy through one year follow-up

Data from ClinicalTrials.gov

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