Head and Neck Neoplasms
Conditions
Interventions
The proposed methodology is a double-blind, randomized, controlled clinical study with two arms involving 36 participants who will be divided into two groups (application of photobiomodulation alone a
E02.594.540
Sponsors
Universidade Federal de Minas Gerais
Hospital do Câncer de Muriaé
Fundação de Amparo à Pesquisa do Estado de Minas Gerais,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patient underwent radiotherapy and chemotherapy with concomitant cisplatin; Patients underwent external radiotherapy with conventional fractionation (1.8 Grays day); and received total dose of 60 Grays or more; Over 18 years old.
Exclusion criteria
Exclusion criteria: Patients with systemic diseases that impair wound healing (diabetes); Patients who cannot understand the research and the Free and Informed Consent Form; Patients with mouth opening difficulties prior to starting the proposed treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: A reduction in the size and duration of oral mucositis lesions is expected. For this purpose, oral mucositis lesions were measured using a malleable ruler, weekly: The size was calculated using the formula: AR= L x W, with AR (area), length (L) or greatest longitudinal axis between the edges of the wound, width (W) or greatest transverse axis of the lesions. The duration of oral mucositis lesions was measured in days.;Outcome found 1: No statistically significant difference was identified in oral mucositis size (p = 0.59) and duration (p = 0.56) when comparing the experimental and control groups. However, the experimental group showed a better means of reduction in oral mucositis size and duration than the control group. The mean reduction in oral mucositis size was 0.70 cm2 (±0.35) for the experimental group and 0.30 cm2 (±1.10) for the control group (p=0.21). The mean duration of the oral mucositis was 18.37 days (±12.12) for the experimental group and 23 days (±14.78) for the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: Reduction in pain. For this, the visual analogue scale was applied weekly to assess the intensity of pain throughout the treatment.;Outcome found 2: No statistically significant difference was identified for pain (p = 0.77) when comparing the experimental and control groups. However, the pain reported by the intervention group showed a mean reduction of 3.40 (±2.44) points on the visual analogic scale, as compared to 0.17 (±2.28) points in the control group.;Expected outcome 3: Assessment of predominant microorganisms in the oral cavity in the presence of oral mucositis. Sterile swab was applied to the entire oral mucosa, except for the tumor area (if present) and the surgical flap region (if present). The samples were stored in Stuart medium and later cultured in Chocolate Agar and MacConkey medium. Phenotype testing was then performed, followed by Vitek® automated device analysis. The microorganisms were categorized according to their prevalence as Gram-negative (GN), Gram-positive (GP) and mixed culture (MC) (when there was abundant growth of microorganisms on the plates, making description impossible). After analysis, the samples were discarded.;Outcome found 3: No statistically significant difference was identified for presence of microorganisms Gram positive, Gram negative, and mixed culture (p = 0.26) when comparing the experimental and control groups. Microbiota was featured in experimental as mixed culture (n = 4/ 50%), Gram positive (n = 3/ 37.50%), and Gram negative (n = 1/12.55%). In the control group, mixed culture was also more frequent (n = 4 / 66%), followed by Gram positive (n = 2 /34%). Gram negative was not predominantly recovered in the control group. | — |
Countries
Brazil
Contacts
Public ContactMaria Cássia;Adriele Aguiar;Lessa
Universidade Federal de Minas Gerais;Hospital do Câncer de Muriaé
Outcome results
None listed