Pilot Study of the Effect of Laser on Reversing Chronic Radiation Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Richard Rox Anderson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01910818
First received: June 5, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic process in the skin which can lead to increased risk of malignancy, poor wound healing, pain and limitation of movement, and permanent loss of skin appendages with hyper/hypopigmentation, decreased sweating and xerosis, posing significant cosmetic and quality of life issues. Advances in laser therapy has led to the use of fractional laser treatment (FLT) to treat fibrosis associated with in hypertrophic scars and morphea, leading to tissue repair, scar remodeling. The investigators propose a pilot clinical study to test the hypothesis that FLT can normalize the fibrotic process and induce normal scar remodeling in patients affected by chronic radiation injury. Understanding and correcting this underlying fibrotic process can help restore normal skin functions in patients affected with chronic radiation dermatitis (RD) and other debilitating fibrotic diseases in dermatology such as scleroderma, morphea, or nephrogenic systemic fibrosis.


Condition Intervention
Chronic Radiation Dermatitis
Device: Fractional CO2 laser treatment
Other: No treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Understanding and Reversing Chronic Radiation Dermatitis - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Improvement in fibrosis (% reduction in fibrosis surface area) compared to controlled sites [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
    The primary end point is % reduction of the fibrosis surface area compared to control sites at 6-12 months.


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Measurement adverse events (infection, scarring, ulceration, excessive bleeding, poor wound healing)


Estimated Enrollment: 22
Study Start Date: November 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fractional CO2 laser Treatment
This is the area getting treated with CO2 laser.
Device: Fractional CO2 laser treatment
Patient will be treated with fractional laser treatment over the areas with fibrosis.
Other Name: Lumenis Ultrapulse CO2 laser
Experimental: No Treatment
This is the area receiving no treatment.
Other: No treatment
Patient will also have an area that is not being treated with CO2 laser. This is the area not getting treatment.

Detailed Description:

We propose to treat 22 patients with significant radiation induced fibrosis (RIF) and skin changes. Each patient will receive fractional treatment (FLT) using the Lumenis Ultrapulse Carbon Dioxide (CO2) laser as well as control (no treatment) randomized to site. Patient age, type of cancer, method/dosage of radiation, latency between radiation treatment and start of study, and characteristics of skin changes will be recorded, including fibrosis surface area, depth, color, and compliance. Assessments will be conducted before each treatment, after each treatment, and 3-12 months after the last treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males and females between 18 and 70 years of age with radiation-induced fibrosis and depigmentation. The fibrosis must have occurred at least 1 year prior to the date of enrollment.
  2. Having suitable areas of treatment: All wounds in the area of interest must be closed for at least two months. The scars must be deemed stable for a period of 3 months or have a suitable contralateral control before initiation of treatment. This will be determined by objective measurements of scar erythema, pliability, induration, thickness at enrollment and again at 3 months;
  3. Fitzpatrick skin types I-VI;
  4. Able and willing to comply with all visit, treatment and evaluation schedules and requirements;
  5. Able to understand and provide written informed consent;
  6. Pregnant woman can be included because study involves local intervention, no new drugs.

Exclusion Criteria:

  1. Active tanning, including the use of tanning booths, during the course of the study;
  2. Prior skin treatment with laser or other devices in the treated area within three months of initial treatment or during the course of the study;
  3. Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
  4. History of collagen vascular disease;
  5. Active Herpes Simplex or Zoster at the time of treatment or having experienced more than three episodes of Herpes Simplex / Zoster eruption within a year of study enrollment;
  6. History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications;
  7. Having any form of active cancer at the time of enrollment and during the course of the study;
  8. Significant concurrent illness, such as uncontrolled diabetes (with a hemoglobin A1C of more than 8) (i.e., any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process); Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
  9. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or study personnel) to treat the subject as part of this research study;
  10. If it is determined that the contracture is due to a deeper process involving the muscles, ligaments or bones.
  11. Patient on chemotherapy (but not tamoxifen or other things that affect wound healing) and also active XRT
  12. Participation in another interventional study with potential exposure to an investigational drug within past 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910818

Contacts
Contact: Richard R Anderson, MD 617-726-3308 rranderson@partners.org
Contact: Thanh-Nga Tran, MD PhD 617-724-4937 ttran2@partners.org

Locations
United States, Massachusetts
Wellman Center for Photomedicine, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard R Anderson, MD    617-726-3308    rranderson@partners.org   
Contact: Thanh-Nga T Tran, MD PhD    617-724-4937    ttran2@partners.org   
Principal Investigator: Richard R Anderson, MD         
Sub-Investigator: Thanh-Nga T. Tran, MD PhD         
Sub-Investigator: Yen-Lin Chen, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Richard R Anderson, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Rox Anderson, MD, Director, Wellman Center for Photomedicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01910818     History of Changes
Other Study ID Numbers: 2013P000988
Study First Received: June 5, 2013
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
radiation
dermatitis
laser
fractional
CO2
chronic
fibrosis
scar

Additional relevant MeSH terms:
Dermatitis
Radiation Injuries
Radiodermatitis
Skin Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014