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Modified Laser Intravascular Blood Irradiation in women with Breast Cancer: clinical trial

Effects of Modified Laser Intravascular Blood Irradiation in women with Breast Cancer: randomized placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3cdtw97
Enrollment
Unknown
Registered
2024-03-11
Start date
2024-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

This is a two-arm, single-blind, randomized controlled clinical study. The Intervention Group will be composed of 30 women with breast cancer undergoing antineoplastic treatment who will receive appli
E02.594.540

Sponsors

Universidade Federal do Paraná
Lead Sponsor
Liga Paranaense de Combate ao Câncer
Collaborator

Eligibility

Sex/Gender
Female
Age
21 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Brazil

Contacts

Public ContactRaciele Guarda Korelo

Universidade Federal do Paraná

raciele@ufpr.br+55 041 991776161

Outcome results

None listed

Source: REBEC (via WHO ICTRP)