Laser InGaAlP (660Nm) to Prevent Radiodermatitis in Breast Cancer Patients Submitted to Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Universidade do Vale do Sapucai
Sponsor:
Information provided by (Responsible Party):
Marina Moreira Costa, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier:
NCT02003599
First received: December 2, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

Breast neoplasm is the second most common type in the world. Radiation therapy is a key component in the treatment of breast cancer. Acute skin reaction is one of the most common side effects of radiation therapy. Several studies were performed for prophylaxis of this adverse event, however, until this moment there is no consensus for clinical practice . Second meta-analysis , the ideal candidate for the radiodermatitis prevention would be an agent capable of repairing damage to DNA or agents that promote cell proliferation . The low power laser promotes tissue repair ( reduces inflammatory phase and induces collagen synthesis ) . Its use in the treatment of adverse events of cancer treatment is well established in two situations : in the prophylaxis and treatment of mucositis and in the treatment of lymphedema . The purpose of this study is to use the low power laser in patients with breast cancer undergoing radiotherapy treatment to evaluate the effects of Laser InGaAIP 660Nm in preventing radiodermatitis.


Condition Intervention
Radiotherapy; Adverse Effect, Dermatitis or Eczema
Breast Neoplasms
Device: Laser therapy
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Laser InGaAlP (660Nm) to Prevent Radiodermatitis in Breast Cancer Patients Submitted to Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Universidade do Vale do Sapucai:

Primary Outcome Measures:
  • Evaluate the effects of Laser InGaAIP 660Nm in preventing radiodermatitis in women submitted to adjuvant radiotherapy. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Skin reactions will be graded weekly by a nurse, by a radiotherapist and by an oncologist using the common toxicity criteria (CTC -developed by the National Cancer Institute ) and Acute Radiation Morbidity Scoring Criteria (developed by Radiation Therapy Oncology Group).


Secondary Outcome Measures:
  • Evaluate the effects of Laser InGaAIP 660Nm in decreased pain secondary to radiodermatitis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pain will be graded weekly by the patient.The patients will answer the modified visual analogue scale for pain (patient self-evaluation) (FERRAZ, 1990).


Estimated Enrollment: 52
Study Start Date: May 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo

In the control group, 26 patients will be submitted to a laser, but the laser will be disabled without affecting its apparent function , five days a week before radiotherapy .

Both arm will use institutional skin care protocol.

Device: Placebo
In the control group, 26 patients will be submitted to a laser, but the laser will be disabled without affecting its apparent function , five days a week before radiotherapy .
Other Name: Placebo Treatment
Experimental: Laser therapy

In the intervention group, 26 patients will be submitted a laser therapy .The low level laser therapy used in this trial will be Photon Lase III (DMC, approved by ANVISA for medicinal purposes). This InGaAIP laser emits a pulsed 660 nanometer beam with an average output of 80 milliwatts and the average energy density delivered to the breast will be 3 J/cm2. It will be administrated five days a week before radiotherapy.

Both arm will use institutional skin care protocol.

Device: Laser therapy
The low level laser therapy used in this trial will be Photon Lase III (DMC, approved by ANVISA for medicinal purposes). This InGaAIP laser emits a pulsed 660 nanometer beam with an average output of 80 milliwatts and the average energy density delivered to the breast will be 3 J/cm2.
Other Names:
  • Low-Level Laser Therapy
  • Low Level Laser Therapy
  • Laser Therapy
  • LLLT

Detailed Description:

This study will be a prospective double- blind trial. Patients with breast cancer with stages I-III undergoing to radiotherapy will be included. The participants will be allocated into an intervention group (laser therapy in 26 patients) or a control group ( in 26 patients the laser will be disabled without affecting its apparent function) , five days a week before radiotherapy . The low level laser therapy used in this trial will be Photon Lase III (DMC, approved by ANVISA for medicinal purposes). This InGaAIP laser emits a pulsed 660 nanometer beam with an average output of 80 milliwatts and the average energy density delivered to the breast will be 3 J/cm2. Skin reactions will be graded weekly by a nurse, by a radiotherapist and by an oncologist using the common toxicity criteria (CTC -developed by the National Cancer Institute ) and Acute Radiation Morbidity Scoring Criteria (developed by Radiation Therapy Oncology Group). The patients will answer the modified visual analogue scale for pain (patient self-evaluation).

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at least 18 years, female gender only.
  2. Patients with histological diagnosis of breast cancer (invasive ductal carcinoma, invasive lobular and other types), stages I-III
  3. Patients who underwent breast-conserving surgery or mastectomy without breast reconstruction
  4. Patients undergoing to adjuvant radiotherapy with conventional dose according to Barretos Cancer's Hospital protocol
  5. Patients in the radiotherapy planning , presenting :

    • In the central court : " Hot Spot " ( ICRU ) ≤ 107 %
    • At full volume : " Hot Spot " ( ICRU ) ≤ 110 %

Exclusion Criteria:

  • Patients undergoing mastectomy with immediate breast reconstruction
  • Patients without histological diagnosis of breast cancer
  • Patients with indication for radiotherapy without conventional dose
  • Patient with indication for treatment in supraclavicular fossa
  • Patients suffering from collagen
  • Patients who do not meet the criteria for planning radiotherapy
  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: NCT02003599

Contacts
Contact: Marina M Costa, MD 553592485252 marina_srs@hotmail.com
Contact: Daniela F Veiga, MD PhD

Locations
Brazil
Hospital do Cancer de Barretos Recruiting
Barretos, SP, Brazil, 14784-345
Contact: Marina M Costa, MD    55-35-92485252    marina_srs@hotmail.com   
Principal Investigator: Marina M Costa, MD         
Sponsors and Collaborators
Marina Moreira Costa
Investigators
Principal Investigator: Marina M Costa, MD Universidade do Vale do Sapucaí
  More Information

No publications provided by Universidade do Vale do Sapucai

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marina Moreira Costa, MD, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier: NCT02003599     History of Changes
Other Study ID Numbers: MPMarina
Study First Received: December 2, 2013
Last Updated: August 12, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade do Vale do Sapucai:
Radiodermatitis
Breast neoplasms
Laser Therapy, Low- Level

Additional relevant MeSH terms:
Neoplasms
Dermatitis
Breast Neoplasms
Radiodermatitis
Skin Diseases
Neoplasms by Site
Breast Diseases
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014