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Completed

NCT Number: NCT01714973

Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

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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Key information

Conditions

Radiation-induced Dermatitis Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ST266

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.

Primary outcomes

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

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

Secondary outcomes

  1. Skin inflammation

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

  2. Quality of Life (QOL)scaled responses

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

    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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Noveome Biotherapeutics, formerly Stemnion

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 26, 2012
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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