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NCT Number: NCT02003599

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

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.

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Key information

Conditions

Radiotherapy; Adverse Effect, Dermatitis or Eczema Breast Diseases Breast Neoplasms Dermatitis Eczema Neoplasms Neoplasms by Site Radiation Injuries Radiodermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases Wounds and Injuries

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital do Cancer de Barretos

Barretos, São Paulo, 14784-345, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Treatment and study plan

Laser Therapy

Device

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, LLLT

PLACEBO

Device

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 names: Placebo Treatment

Primary outcomes

  1. Evaluate the effects of Laser InGaAIP 660Nm in preventing radiodermatitis in women submitted to adjuvant radiotherapy.

    Time frame: 3 months

    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 outcomes

  1. Evaluate the effects of Laser InGaAIP 660Nm in decreased pain secondary to radiodermatitis

    Time frame: 3 months

    Pain will be graded weekly by the patient.The patients will answer the modified visual analogue scale for pain (patient self-evaluation) (FERRAZ, 1990).

Sponsors and collaborators

Lead sponsor

Universidade do Vale do Sapucai

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 6, 2013
Registry last updated
May 14, 2018

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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