Modified Laser Intravascular Blood Irradiation in women with Breast Cancer: clinical trial
- Conditions
- Breast Cancer
- Registration Number
- RBR-3cdtw97
- Lead Sponsor
- niversidade Federal do Paraná
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Women over the age of 21; with a clinical diagnosis of unilateral or bilateral primary breast cancer; undergoing conventional adjuvant antineoplastic treatment (chemotherapy, radiotherapy or hormonal therapy); whether or not undergoing surgical treatment to remove the solid tumor; with a score between 0 to 2 on ECGO-OS (Eastern Cooperative Oncology Group Performance Status); with the ability to communicate in Portuguese; residing in Curitiba or the Metropolitan Region; available to participate in research interventions in a 10-week follow-up schedule
Women under 21; who do not agree to participate in this study; illiterate or who present cognitive deficit determined by the MMSE questionnaire - Mini Mental State Examination; hearing deficit that prevents understanding verbal instructions; with the presence or suspicion of metastatic areas, presence of allergies or skin diseases (atopic dermatitis, contact dermatitis, psoriasis or rosacea); pregnant or lactating women; women with a body mass index (BMI) above 40 (due to the presence of comorbidities related to obesity that may interfere with the results); contraindications for the application of mILIB will (cardiogenic shock, arterial hypotension, heart disease, circulatory failure in stages II and III, anemia, sick sinus syndrome, existence of blood coagulopathies, personal history of cancer at the application site); hemorrhagic, infected or photosensitive area; women with phototype VI on the Fitzpatrick scale confirmed by the analyzer as phototype V; blood tumors; pacemaker
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected to find a one-point reduction in the severity of adverse events related to adjuvant antineoplastic treatment, with a one-point reduction in severity on the scale of the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events<br><br>
- Secondary Outcome Measures
Name Time Method It is expected to find a 20% reduction in pain, sensation of heaviness and perception of limb edema verified by the 11-point Numerical Scale