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

May 8, 2018 updated by: Universidade do Vale do Sapucai
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Barretos, SP, Brazil, 14784-345
        • Hospital do Cancer de Barretos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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:
  • LLLT
  • Low-Level Laser Therapy
  • Low Level Laser Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Vale do Sapucai

Investigators

  • Principal Investigator: Marina M Costa, MD, Universidade do Vale do Sapucai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPMarina

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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