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

NCT02003599 | Completed

• 1 other identifier: MPMarina
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy; Adverse Effect, Dermatitis or Eczema; Breast Neoplasms

Keywords

Radiodermatitis; Breast neoplasms; Laser Therapy, Low- Level

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Secondary Outcomes (1)

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

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Laser therapy

EXPERIMENTAL

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

Interventions

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.

Also known as: Low-Level Laser Therapy, Low Level Laser Therapy, LLLT

Laser therapy

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 .

Also known as: Placebo Treatment

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Hospital do Cancer de Barretos

Barretos, São Paulo, 14784-345, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25141962 DERIVED

MeSH Terms

Conditions

Dermatitis; Eczema; Breast Neoplasms; Radiodermatitis

Interventions

Laser Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Neoplasms by Site; Neoplasms; Breast Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Phototherapy

Study Officials

• Marina M Costa, MD

  Universidade do Vale do Sapucaí

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 14, 2018

Record last verified: 2015-05

Locations

BR (1)