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Photobiomodulation for Breast Cancer Radiodermatitis

NCT04059809 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-08-13

No results posted yet for this study

Summary

A prospective single blind controlled randomized trial to evaluate the superiority of photobiomodulation (PBM) using LED-therapy in reducing the prevalence of radiodermatitis in breast cancer compared to usual local care.

Conditions

  • Breast Cancer
  • Radiodermatitis
  • Radiotherapy Side Effect
  • Radiation Dermatitis
  • Radiation Toxicity
  • Radiation Injuries
  • Quality of Life
  • Breast Neoplasms

Interventions

DEVICE

Photobiomodulation

Photobiomodulation will be with the Cicatrillux (Cosmedical®) LED that contains 36 red light emitters in a 10x12 cm neoprene plate with 650 nm LED wave length whose optical spot diameter is 5 mm and with an average wave length of 2 \~ 5 mw for 10 minutes that will be placed over the area that will be irradiated for 10 minutes;

Sponsors & Collaborators

  • AC Camargo Cancer Center

    lead OTHER

Principal Investigators

  • Glauco Baiocchi, MD, PhD · AC Camargo Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2021-07-20
Completion
2021-07-20

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04059809 on ClinicalTrials.gov