Influence of Low Intensity Laser Therapy treatment and severity of Diseugia in breast and prostate cancer patients treated with taxanes: trial randomized, triple-blind, placebo-controlled trial

Phase 2

Recruiting

• Conditions: Change in taste of patients undergoing chemotherapy treatment for breast and prostate cancerDysgeusia; laser therapy; breast cancer; prostate cancer; C00-D48

• Registration Number: RBR-9qnm34y
• Lead Sponsor: Escola Cearense de Oncologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients older than 18 years with stage II, III and IV cancer free of previous chemotherapy treatment undergoing first adjuvant or neoadjuvant treatment with protocols of drugs of the taxane class (paclitaxel (Taxol®) or docetaxel (Taxotere® ) Chemotherapy protocols may or may not be associated with other drugs.

Exclusion Criteria

Patients with a history of radiotherapy in the head and neck, smokers, with anemia (hemoglobin less than 12 g / dl in women or 13 g / dl in men), untreated diabetes mellitus (from 200 mg / dL), using drugs that significantly alter the salivary flow, saliva composition, or taste (VRIES et al., 2018), in the use of central acting analgesics or anxiolytics and antidepressants. Patients who withdraw from treatment or study will be withdrawn from the study, requiring a change in the chemotherapy protocol with substitution of taxanes, discontinuing chemotherapy for any reason or developing systemic infections.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease and / or prevention of taste alteration through the application of laser therapy prior to chemotherapy, since in the study by VRIES et al. (2018) who observed a significant variation in taste loss scores in patients with breast cancer treated with chemotherapy from the pre-chemotherapy moment (22.67 ± 6.69) up to six months after the end of treatment (28.45 ± 4 , 08).Laser therapy has already been effective for the treatment and prevention of various alterations in the oral cavity; however, there are no studies addressing the use of this therapeutic measure for dysgeusia.

Secondary Outcome Measures

Name	Time	Method
aser therapy can reduce pain, discomfort, induce neural stimuli, as well as regenerate epithelium that in turn promotes cell repair. As the cause of dysgeusia is not yet elucidated, we will apply laser therapy in both red and infrared light in order to reach all the pathways that may cause this change.