Tumor Necrosis Factor-alpha
Conditions
Interventions
This will be a phase II randomized, triple-blind, placebo-controlled clinical trial conducted between 2025 and 2026. It will include two study groups of breast cancer patients initiating antineoplasti
E02.594.540
Sponsors
Instituto do Câncer do Ceará
Instituto do Câncer do Ceará
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years of age with stage II, III, or IV breast cancer; with no prior chemotherapy treatment; undergoing their first adjuvant, neoadjuvant, or palliative treatment with drug protocols from the anthracycline and alkylating agent classes
Exclusion criteria
Exclusion criteria: Patients with a history of head and neck radiotherapy; smokers; those with untreated anemia or diabetes mellitus; those using drugs that significantly alter salivary flow, saliva composition, or taste; those using centrally acting analgesics, anxiolytics, or antidepressants. Patients with a previous history of dysgeusia or with alterations in smell and taste following COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the influence of tumor necrosis factor-alpha (TNF-a) polymorphism and its receptors on the risk of dysgeusia and resistance to preventive photobiomodulation in breast cancer patients treated with doxorubicin and cyclophosphamide through a randomized, triple-blind, placebo-controlled clinical trial. Clinical data will be expressed as absolute and relative frequencies and compared using Pearson’s chi-square or Fisher’s exact test. Data from taste acuity tests and dysgeusia scores will be expressed as mean and standard deviation, and compared using the Mann-Whitney test (between-group comparison) or Friedman/Dunn test (within-group comparison) for non-parametric data. A multinomial logistic regression model will be used to assess the independent relationship between the studied gene polymorphisms and the severity of dysgeusia. All analyses will be performed using the Statistical Package for the Social Sciences (SPSS) version 20.0 for Windows, adopting a 95% confidence level. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to longitudinally and prospectively evaluate chemotherapy-related dysgeusia in breast cancer patients. To longitudinally assess the control of chemotherapy-induced dysgeusia through photobiomodulation therapy using red light wavelength. It is expected to evaluate the frequency of TNF-a gene polymorphisms and their receptors in breast cancer patients undergoing chemotherapy. It is expected to assess the influence of TNF-a gene polymorphisms and their receptors on the incidence and severity of chemotherapy-related dysgeusia in breast cancer patients. It is expected to evaluate the influence of TNF-a gene polymorphisms and their receptors on the control of chemotherapy-induced dysgeusia through low-level laser photobiomodulation using red light wavelength in breast cancer patients | — |
Countries
Brazil
Contacts
Public ContactGiulianna Barreto
Instituto do Câncer do Ceará
Outcome results
None listed