Skip to content

Laser therapy effectiveness on skin with chemotherapy Side Effects, randomized clinical trial

Intervention on the systemic adverse effects of modified intravascular laser irradiation of blood chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7y8rtz
Enrollment
Unknown
Registered
2019-10-16
Start date
2018-03-01
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

Neoplasms

Interventions

For the interventions will be used the low intensity laser equipment, whose active medium is a semiconductor diode, emitting at wavelength 660nm, with optical power of 100 mW, beam cross-sectional are
diarrhea / patient with colostomy
nausea
dyspepsia
Vomit. • Control Group (n:21), will not receive laser therapy
• ILIB 30 'Group (n:21): will receive laser application for 30 minutes daily, for 10 consecutive days, working on Saturdays, Sundays and holidays. Finished the first cycle, rested 20 days and will be
• ILIB 60 'Group (Intervention Group)(n:13): you will receive the laser application for 60 minutes daily, within 10 days, with two-day intervals between each application, that is, you will receive the
Device
E02.594.540

Sponsors

Unesp- Universidade Estadual Paulista
Lead Sponsor
Unesp- Universidade Estadual Paulista
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older; in exclusive outpatient treatment; no self-reported cognitive impairment by patient and companion; with solid tumors; submitted to at least one chemotherapy cycle before data collection

Exclusion criteria

Exclusion criteria: Excluded patients will be those undergoing oral and / or subcutaneous and / or intramuscular chemotherapy only; those who do not have cognitive conditions to answer the form; as well as colostomized individuals; those taking medications known to affect the immune system; in hematological treatment

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of transcutaneous ILIB applied for 30 and 60 minutes on side effects in the gastrointestinal tract (nausea, vomiting, diarrhea and constipation) in cancer patients undergoing ambulatory intravenous chemotherapy. It is noteworthy that, to follow this evolution, items from the Toxicity Scale of the National Cancer Institute of the United States were used: constipation, diarrhea / patient without colostomy; nausea; dyspepsia; vomit Being considered efficacy lower degrees of constipation, diarrhea / patient without colostomy; nausea; dyspepsia; vomiting, according to the scale proposed by the Scale mentioned above and comparison between the three groups;To evaluate the efficacy of transcutaneous ILIB applied for 30 and 60 minutes on side effects in hematopoietic tissue (thrombocytopenias, neutropenias and hemoglobin alterations) in cancer patients. Being evaluated by the protocol of examination of the collaborating institution (hemoglobin equal to or greater than 9.0 / dl, platelets equal to or greater than 100,000 mm³ and neutrophil equal to or greater than 1,500 mm³). Being effective for intervention when the patient maintained the hematological parameters. recommended for continuity of treatment

Secondary

MeasureTime frame
To evaluate the adverse effects on skin integrity (application site) of patients exposed to transcutaneous ILIB, especially signs of burns, evaluated according to the 1st, 2nd and 3rd degree burns.

Countries

Brazil

Contacts

Public ContactSilvia Bocchi

Unesp- Universidade Estadual Paulista

silvia.bocchi@unesp.br55 - 14 - 38801314

Outcome results

None listed

Source: REBEC (via WHO ICTRP)