Laser InGaAlP (660Nm) to Prevent Radiodermatitis in Breast Cancer Patients Submitted to Radiation Therapy
Condition: Radiotherapy; Adverse Effect, Dermatitis or Eczema; Breast Neoplasms
MeSH terms: Breast Neoplasms; Dermatitis; Radiodermatitis
Study type: Interventional

Summary: 
      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.
    

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).
    

Intervention name(s): Laser therapy; Placebo
Intervention type(s): Device; Device
Intervention description(s): 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.; 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 intervention name(s): Low-Level Laser Therapy; Low Level Laser Therapy; LLLT; Placebo Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Radiodermatitis; Breast neoplasms; Laser Therapy, Low- Level