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The purpose of this longitudinal study was to examine the impact of different types of oral care on grades of radiation-induced oral mucositis, body weight, and quality of life for the head and neck cancer patients during radiotherapy.
Introduction
Oral cavity is the major location that exhibits the toxic effects of radiotherapy and chemotherapy for head and neck cancer patients. Oral mucositis is one of the most common complications among these patients. Severe oral mucositis can lead to secondary complications (ie. loss of body weight) and delay the planned treatment protocols.
Literature shows that oral care or used honey as agent can reduce the incidence of oral mucositis. What will happen if we combine these two strategies as a protocol for oral care? Therefore, we conducted this clinical trial to find the impact of combination.
Patients and methods
Patients were recruited from a medical center, Taiwan. During May 2012 and August 2013, a total of 97 head and neck cancer patients undergoing radiotherapy were contacted and 94 subjects completed the whole study protocol. The reasons of drop out were: side-effect (1), too afraid of treatment(1), and move to other hospital(1). Informed consent was obtained before the study started.
Inclusion and exclusion criteria
Those who diagnosed with head and neck cancer, plan to receive radiotherapy with least doses of 6000cGy as part of their treatment protocol, and older than 20 years were recruited. Those who have been diagnosed as DM with HbA1C > 7% within 3 months, Karnofsky Performance Scale < 60, or suffering from grade 4 oral mucositis were all excluded.
Study design
They were randomly stratified into three groups, where groupⅠreceived honey mouthwash, instruction of oral care, and routine care; groupⅡreceived instruction of oral care and routine care; and groupⅢas control group, received routine care only. The honey mouthwash was to swish 20 cc nature and undiluted honey in mouth for 2 minutes and then swallowed it prior to RT, at 15 minutes and 6 hours after RT respectively.
Prior to radiotherapy, all patients completed Chinese version of EORTC QLQ-C30 and EORTC QLQ-H&N35. An evaluation of their oral mucosa was conducted at the same time by a single researcher. These questionnaires also need to be completed while the cumulative RT dose at 40Gy and at the end of RT course. Their oral mucosa was evaluated when the RT doses were cumulated up to 10, 20, 30, 40, 50, 60 Gy and at the end of RT course respectively. Their body weight was measured at the beginning of the study and weekly during the period of treatment.
Statistical analysis
Data were analyzed by the Statistical package for the Social Sciences 18 (SPSS) program. Descriptive (mean, SD, %) and inferential statistics (chi-square, Survival Analysis, One way ANOVA, Generalized Estimating Equation) were performed.
Results
The results showed that these three groups were homogeneous in their demographic variables and disease-related variables prior to radiotherapy.
Mucositis (Primary Outcome)
The first onset of grade 1 mucositis was significantly different among these three groups by Log-Rank test survival analysis (F= 8.29, p<.001) whereas the results of Post Hoc Bonferroni analysis showed that the first onset of grade 1 mucositis in control group was significant quicker than groupⅠandⅡ. Mean value of the first onset of these 3 groups were: 11th day (groupⅠ, SD= 4.20, range= 6~26 day); 10th day (groupⅡ, SD= 4.47, range= 4~30 day); and 9th day (control group, SD= 2.63, range= 4~14 day) respectively.
In regard to the ratio for occurrence of oral mucositis at each point of assessment, groupⅠandⅡhad a trend of lower ratio than the control group at the 3th, 4th, amd 6thassessment.
None of the patients developed grade 4 mucositis. However, when the dose of RT cumulated > 40 Gy, the ratio of grade 3 mucositis was significant lower in groupⅠandⅡwhen compared with control group (X2= 19.06~40.98, p<.001).
Body Weight(Secondary Outcome)
The comparisons of weekly changes in body weight showed that groupⅠandⅡhad less changes than the control group (X2= 15.88~.9.00, p<.001). The range of changes in body weight were 0.95 to -2.52 kg (groupⅠ), 0.75 ~ -1.81 kg (groupⅡ), and -0.81 ~ -4.77 kg (control group) respectively.
Quality of Life (Secondary Outcome)
The study found that, for all patients, the overall quality of life were significantly decreased along with the cumulated doses of radiation (Wald X2= 44.99, p <.001).
After adjusting the group, time and interaction effects, the results of GEE for EORTC QOL-C30 and EORTC QOL-H&N35 found that, at RT 40 Gy, the symptom scales of "appetite(Wald X2= 5.47, p=0.02)" and "sociability eating(Wald X2= 4.74, p=0.03)" were significantly less problems in groupⅡwhen compared with control group. At the end of RT, the functional scales of "physical functioning(Wald X2= 7.23, p=0.01; Wald X2= 4.43, p=0.04)" in groupⅠand groupⅡwere significantly better than the control group. In addition, the functional scales of "role functioning(Wald X2= 4.28, p=0.04)" in groupⅡwas significantly better and the symptom scales of "appetite(Wald X2= 6.38, p=0.01)", "speech problems(Wald X2= 7.13, p=0.01)", "sociability eating(Wald X2= 4.28, p=0.04)", and "social contact(Wald X2= 5.68, p=0.02)" were significantly less problems than the control group.
Conclusion
This study showed that, when compared with the control group, patients in both experimental group reported less occurrence and late onset of first mucositis, less severe oral mucositis, less weekly body changes, and even better quality of life during research period. Therefore, the application of “honey mouthwash plus instruction of oral care” or “instruction of oral care alone” were strongly suggested in clinical practice.
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