Benzydamine for prophylaxis of radiation induced oral mucositis in head and neck cancers: Double-blind clinical trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9042-9042
Author(s):  
S. Kamian
Keyword(s):  
Placebo Group ◽  
Head And Neck ◽  
Oral Mucositis ◽  
Treated Group ◽  
Head And Neck Cancers ◽  
Control Group ◽  
Oral Rinse ◽  
Neck Tumors ◽  
Radiation Induced ◽  
Grade 3

9042 Background: Oral mucositis is one of the most common adverse effects of radiotherapy in head and neck tumors. We determined the efficacy of oral rinse benzydamine in prevention of radiation induced mucositis. Methods: Patients with head and neck cancers were enrolled in a randomize, placebo-controlled clinical trail to receive either benzydamine or placebo. All the cases received at least 50 Gy radiation to the oral cavity and oropharyngeal areas. The end points were comparison of highest grade of mucositis at the end of radiotherapy, frequency of grade 2 or more, the interval days to establishing grade 2 in the groups. Results: 100 patients with head and neck cancers were randomized in this trail. At the end of the study, 19 patients were excluded of the analysis due to minor side effects of drug, or stopping the radiotherapy. In 39 cases in the treated group, the frequency of mucositis grade 3 or more was 43.6% (17 cases) in contrast to 78.6% (33 cases) in 42 cases in the placebo group, which was significant (p=0.001). Mucositis grade 3 or more was 2.6 times frequent in placebo group (CI=95%, relative risk=1.38–5). At the end of RT, at least 42% of the treated group had mucositis grade 3 or more in contrast to at least 76% in the control group which was statistically significant. Intensity of mucositis was increased up to forth week of treatment in both groups to grade 2. In the treated group the grade of mucositis was approximately constant to the end of therapy; but in the control group it raised to grade 3 (p<0.001). The highest grade of mucositis during the treatment time was significantly different between two groups (p=0.049). The median interval days of establishing grade 2 mucositis was 3.6 days sooner in the placebo group (p=0.12). Conclusions: According to these results it seems that oral rinse benzydamine was effective, safe, and well tolerated for prophylactic treatment of radiation-induced oral mucositis in head and neck tumors. [Table: see text]

Oral morphine gargles: A cost effective approach for pain relief in patients with chemoradiation induced acute oral mucositis in head and neck cancers

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20504-e20504
Author(s):  
C. Haritha ◽  
V. Shankar
Keyword(s):  
Side Effects ◽  
Pain Relief ◽  
Supportive Care ◽  
Head And Neck ◽  
Oral Mucositis ◽  
Oral Morphine ◽  
Head And Neck Cancers ◽  
Control Group ◽  
Morphine Group ◽  
Systemic Side Effects

e20504 Background: Painful oral mucositis is the most significant dose-limiting toxicity in head & neck cancer patients treated with conc. CT-RT protocol. The purpose of this study is to evaluate the efficacy of oral morphine gargles in reducing the severity of chemoradiation induced mucositis pain & thus, its impact on nutrition, quality of life & cost of supportive care, during the treatment period. Methods: 106 consecutive patients, recruited between May 2006 through Dec. 2007, with adv. head and neck cancers (54 oropharynx, 42 hypopharynx & 10 nasopharynx) were included in the study. All patients underwent treatment under conc. CT-RT (Inj.CDDP 40mg/m2 weekly, RT: 66–70gy/33–35# @200cgy/# delivered by 3D- CRT). Patients who had painful mucositis (RTOG Grade 3 or more) not controlled with magic mouthwash, Tab. Acetaminophen 500mg qds or Tab.Tramdol 50–100 mg tds were randomized into 2 groups: morphine group (MOP) -53 patients & Control group (CON) - 53 patients. Patients in both groups received adjusted doses of oral steroids based on the severity of oral mucositis. While CON group patients were given adjusted doses of tramadol, MOP group patients were assigned to 15ml of 2% morphine gargles administered every 4th hourly. Patients were instructed not to swallow the rinses and to hold the solution in the mouth for 3mins duration. All patients underwent weekly recording of (1) response to pain rated on VAS (2) weight (3) morphine systemic side-effects (4) QOL Questionnaire. Mann-Whitney test and ’T’ Test are used for statistical analysis of the data. Results: Patients in the MOP group had significant lower pain intensity scores, better QOL scores & less weight loss compared to patients in the CON group. The duration of the severe pain was atleast 1 week shorter in the MOP group. Systemic side-effects secondary (nausea, vomiting, constipation) to opiod use were significantly lower in the MOP group. The Cost of supportive care for pain management was less in the MOP group, with greater compliance for the treatment. Conclusions: Morphine gargles, in our experience, is an effective approach for pain relief in patients with CT-RT induced acute mucositis in head and neck cancers thus leading to better nutrition & compliance in the treatment. No significant financial relationships to disclose.

RK-0202 for radiation-induced oral mucositis

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5523-5523 ◽  
Author(s):  
M. S. Chambers ◽  
D. V. Welsh ◽  
R. A. Scrimger ◽  
W. Zehn ◽  
J. B. Epstein ◽  
...  
Keyword(s):  
Adverse Events ◽  
Head And Neck ◽  
Oral Mucositis ◽  
Tube Placement ◽  
Double Blind Study ◽  
Serious Adverse Events ◽  
Who Grade ◽  
Oral Rinse ◽  
Grade 3 ◽  
Severe Oral Mucositis

5523 Background: This study evaluated the effect of RK-0202, administered as an oral rinse, on the incidence of severe oral mucositis in patients being treated with of radiation therapy (RT) for tumors of the head and neck. Methods: This was a prospective, randomized, placebo-controlled, double-blind study that compared the effect of 2 concentrations of RK-0202 with placebo on the incidence of severe oral mucositis at a cumulative RT dose of 60 Gy in 110 subjects. Twenty-seven subjects received RK-0202 5%, 38 received RK-0202 10%, 29 received placebo and 16 received standard of care. Subjects began dosing just prior to RT and continued dosing six times daily throughout RT. Oral mucositis was assessed twice weekly throughout RT by trained oral evaluators. Results: The higher dose of RK-0202 (10%) successfully attenuated severe oral mucositis as measured by WHO or NCI-CTC v.3 criteria. The incidence of WHO grade 3 or 4 oral mucositis by a cumulative RT dose of 60 Gy was 35% in the RK-0202 group vs. 54% in the placebo group (p = NS). By 50 Gy the incidences in the RK-0202 and placebo groups were 25% and 54%, respectively (p = 0.053). Similarly, the incidence of NCI grade 3 or 4 oral mucositis by 60 Gy was 64% in the RK-0202 cohort vs. 92% for subjects being treated with placebo (p = 0.005). Subjects treated with RK-0202 required less feeding tube placement compared to placebo recipients (3% vs. 22%, p = 0.037) and less opiate analgesia. The median percent of time on opiates was 6% on RK-0202 vs. 21% on placebo. The overall incidence of serious adverse events was significantly lower in subjects treated with RK-0202 (8% vs. 31%, p = 0.024). In general, there was no benefit noted among subjects who received RK-0202 as a 5% solution. Conclusions: RK-0202 significantly reduced the incidence of severe mucositis in subjects treated with radiotherapy for head and neck cancer and was not associated with significant adverse events. [Table: see text]

scholarly journals Role of oral glutamine in alleviation and prevention of radiation-induced oral mucositis: A prospective randomized study

2014 ◽  
Vol 03 (01) ◽  
pp. 008-012 ◽  
Author(s):  
Subrata Chattopadhyay ◽  
Aramita Saha ◽  
Mohammad Azam ◽  
Anindya Mukherjee ◽  
Prabir Kumar Sur
Keyword(s):  
Head And Neck ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
Randomized Study ◽  
Neck Region ◽  
Adjuvant Radiation ◽  
Head Neck Cancer ◽  
Neck Malignancy ◽  
Radiation Induced ◽  
Grade 3

Abstract Background: Oral mucositis is the most frequently occurring painful and dose-limiting side-effect of radiation of the head and neck region. Few studies demonstrated that oral glutamine suspension may significantly reduce the duration and severity of objective oral mucositis during radiotherapy. Materials and Methods: A randomized, prospective single institutional case control study was performed between April 2012 and November 2012 comparing the influence of oral glutamine on radiation induced mucositis in head and neck malignancy patients. Seventy biopsy proven patients with head and neck cancer receiving primary or adjuvant radiation therapy were randomized to receive either oral glutamine suspension daily 2h before radiation in the study arm (10 g in 1000 ml of water) (n = 35) or nothing before radiation; control arm (n = 35). Results and Analysis: Total 32 patients (91.43%) in the glutamine arm and total 34 patients (97.15%) developed mucositis. Grade 3 mucositis (14.29%) and grade 4 mucositis (2.86%) in the study arm (who received oral glutamine) were significantly less (P = 0.02 and P = 0.04, respectively) in the glutamine arm. The mean duration of grade 3 or worse mucositis (grade 3 and grade 4) was significantly less (6.6 days vs. 9.2 days) in study arm with P < 0.001. Mean time of onset of mucositis was significantly delayed in patients who took glutamine in comparison to control arm with P < 0.001. Conclusion: Glutamine delays oral mucositis in the head neck cancer patients. Moreover, it reduces the frequency and duration of grade 3 and grade 4 mucositis.

scholarly journals Prospective randomized trial to compare the outcome and tolerability of delivering the same total dose of radiation in 61/2 weeks versus 51/2 weeks time in head and neck cancers

2015 ◽  
Vol 04 (03) ◽  
pp. 118-122
Author(s):  
Manoj Gupta ◽  
Siddharth Vats ◽  
Tapesh Bhattacharyya ◽  
Rajeev K. Seem ◽  
Manish Gupta ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Treatment Time ◽  
Head And Neck Cancers ◽  
Control Group ◽  
Tumor Control ◽  
Number Of Patients ◽  
Grade 3

Abstract Background: Concurrent chemoradiation is currently considered to be the standard of care in the treatment of head and neck cancer. In developing countries like ours, a good number of patients cannot tolerate chemoradiation because of the poor general condition and financial constraints. Those patients are treated with radiation alone. The optimum radiotherapy (RT) schedule for best local control and acceptable toxicity is not yet clear. We aimed to find out whether shortening of treatment time using six instead of five RT fractions per week improves the locoregional control in squamous cell carcinoma of head and neck. Materials and Methods: We conducted a prospective randomized study for a period of 2 years from September 2007 to August 2009 in 109 untreated patients of squamous cell carcinoma of head and neck with histologically confirmed diagnosis and no evidence of distant metastasis. Study group (55 patients) received accelerated RT with 6 fractions per week (66 Gy/33#/51/2 weeks). Control group (54 patients) received conventional RT with 5 fractions per week (66 Gy/33#/61/2 weeks). Tumor control, survival, acute and late toxicities were assessed. Results: At a median follow-up of 43 months, 29 patients (52.7%) in the 6 fractions group and 24 patients (44.4%) in the 5 fractions group were disease-free (P = 0.852). The benefit of shortening was higher for advanced disease control though it was not statistically significant. Grade 3 and 4 skin toxicity was significantly higher in the accelerated RT (70.9%) arm as compared to conventional (35.1%) arm (P = 0.04). Grade 3 mucositis was significantly higher in the accelerated RT arm (32.7% vs. 16.6%; P = 0.041). Those acute toxicities were managed conservatively. There was no difference in late toxicities between the two arms. Conclusion: Use of 6 fractions per week instead of 5 fractions per week is feasible, tolerable, and results in a better outcome in the patients of head and neck cancers.

scholarly journals EFFECTIVENESS OF TOPICAL APPLICATION OF MIXTURE OF HONEY AND COFFEE IN RADIATION INDUCED ORAL MUCOSITIS AMONG PATIENTS WITH HEAD & NECK CANCER UNDERGOING RADIOTHERAPY AT RADIOTHERAPY DEPARTMENT OF KGMU, LUCKNOW, U.P

2020 ◽  
Vol 8 (10) ◽  
pp. 55-62
Author(s):  
Anjali Verma ◽  
◽  
Rashmi P. John ◽  
Kirti Srivastava ◽  
◽  
...  
Keyword(s):  
Head And Neck ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
Sampling Technique ◽  
Control Group ◽  
Study Group ◽  
Head Neck Cancer ◽  
Control Group Design ◽  
Quasi Experimental ◽  
Radiation Induced

Background: Cancers commonly known as head and neck cancers typically begin in the squamous cells that line the moist, mucosal surfaces within the head and neck. Oral mucositis is erythematous and ulcerative lesion of the oral mucosa in patients with cancer being treated with chemotherapy/ radiation therapy in the areas of oral cavity. Objectives: To assess the grade of the oral mucositis among head & neck cancer patients receiving radiotherapy. 2. To evaluate the effectiveness of mixture of honey and coffee application on radiation induced oral mucositis among the study group. 3. To find the association between the radiation induced oral mucositis with selected demographic variables. Method: quasi experimental non randomized control group design was applied and 60 samples (30 in each group) were selected by convenience sampling technique. The mixture of honey and coffee was applied to the study group before and after 15 minutes of radiotherapy till the continuation of radiotherapy and no intervention was given in the control group. Result: The result revealed that the application of honey and coffee mixture was significantly effective on oral mucositis (p<0.001) in the study group. Conclusion: The study concluded that, application of mixture of honey and coffee is an effective method of reducing the onset and severity of oral mucositis in comparison with no intervention.

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