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

Sponsor

Universidade do Vale do Sapucai (Other)

Overall Status

Completed

CT.gov ID

NCT02003599

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Radiotherapy; Adverse Effect, Dermatitis or Eczema Breast Neoplasms	Device: Laser therapy Device: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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: Low-Level Laser Therapy Low Level Laser Therapy LLLT

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:

Low-Level Laser Therapy

Low Level Laser Therapy

LLLT

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 %