Health Condition 1: K123- Oral mucositis (ulcerative)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Both male and female patients aged above 18 years will be included in the study. Participants with histopathologically proven head and neck carcinoma scheduled to undergo radiotherapy involving at least two third of oral cavity in radiation field.
Exclusion criteria
Exclusion criteria: 1.Participants who do not wish to participate or refuse to give a written consent for the study will be excluded from the study. 2.Patients receiving induction chemotherapy or receiving concurrent chemotherapy for treatment of head and neck carcinoma 3. Patients undergoing palliative therapy, short duration radiotherapy will be excluded 4. Patients were excluded if they had lock jaw, any medical condition affecting healing mechanisms (like diabetes), prior radiation for head and neck carcinoma, were receiving any chemo-sensitizer and were not receiving high dose radiation to oral cavity region. 5.Patients allergic to the ingredients of mouthwash. 6.Elderly patients with morbidity, pregnant and lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare the intensity and duration of radiation-induced oral mucositis between low level laser therapy, polyherbal mouth wash and placebo group by World Health organization (WHO) scale and Oral Mucositis Assessment Scale (OMAS). To assess and compare the maximum pain score by visual analog scale of radiation-induced oral mucositis between low level laser therapy, polyherbal mouth wash and placebo group. Timepoint: Baseline, 3rd week and 6th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate quality of life by European organisation for research and treatment of cancer (EORTC QLQ) questionnaire in participants before and after treatment of radiation-induced oral mucositis between low level laser therapy, polyherbal mouth wash and placebo group To assess the incidence of supplemental nutrition through feeding tube between low level laser therapy, polyherbal mouth wash and placebo group To assess body weight loss between low level laser therapy, polyherbal mouth wash and placebo group To assess incidence and duration of radiation therapy interruption if any between low level laser therapy, polyherbal mouth wash and placebo group. Timepoint: 2nd week to sixth week | — |
Countries
India
Contacts
K M Shah Dental College and Hospital