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

Primary Purpose

Radiotherapy; Adverse Effect, Dermatitis or Eczema, Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser therapy
Placebo
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiotherapy; Adverse Effect, Dermatitis or Eczema focused on measuring Radiodermatitis, Breast neoplasms, Laser Therapy, Low- Level

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital do Cancer de Barretos

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Laser therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evaluate the effects of Laser InGaAIP 660Nm in preventing radiodermatitis in women submitted to adjuvant radiotherapy.
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
Pain will be graded weekly by the patient.The patients will answer the modified visual analogue scale for pain (patient self-evaluation) (FERRAZ, 1990).

Full Information

First Posted
December 2, 2013
Last Updated
May 8, 2018
Sponsor
Universidade do Vale do Sapucai
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1. Study Identification

Unique Protocol Identification Number
NCT02003599
Brief Title
Laser InGaAlP (660Nm) to Prevent Radiodermatitis in Breast Cancer Patients Submitted to Radiation Therapy
Official Title
Laser InGaAlP (660Nm) to Prevent Radiodermatitis in Breast Cancer Patients Submitted to Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Vale do Sapucai

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy; Adverse Effect, Dermatitis or Eczema, Breast Neoplasms
Keywords
Radiodermatitis, Breast neoplasms, Laser Therapy, Low- Level

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Laser therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Laser therapy
Other Intervention Name(s)
Low-Level Laser Therapy, Low Level Laser Therapy, LLLT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Treatment
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Evaluate the effects of Laser InGaAIP 660Nm in preventing radiodermatitis in women submitted to adjuvant radiotherapy.
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Evaluate the effects of Laser InGaAIP 660Nm in decreased pain secondary to radiodermatitis
Description
Pain will be graded weekly by the patient.The patients will answer the modified visual analogue scale for pain (patient self-evaluation) (FERRAZ, 1990).
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina M Costa, MD
Organizational Affiliation
Universidade do Vale do Sapucaí
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital do Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-345
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25141962
Citation
Costa MM, Silva SB, Quinto AL, Pasquinelli PF, de Queiroz dos Santos V, de Cassia Santos G, Veiga DF. Phototherapy 660 nm for the prevention of radiodermatitis in breast cancer patients receiving radiation therapy: study protocol for a randomized controlled trial. Trials. 2014 Aug 20;15:330. doi: 10.1186/1745-6215-15-330.
Results Reference
derived

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

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