Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Radiation-induced Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ST266 intact

Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The first cohort will receive ST266 and saline placebo applied to intact skin beginning immediately following the first radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.

Group Type EXPERIMENTAL

ST266

Intervention Type BIOLOGICAL

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.

ST266 inflamed

Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The second cohort will receive ST266 and saline placebo applied to inflamed skin (after inflammation is first noted) beginning immediately following the radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.

Group Type EXPERIMENTAL

ST266

Intervention Type BIOLOGICAL

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.

Interventions

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ST266

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No