Effectiveness of Cryotherapy on Radiation Induced Oral Mucositis among patients who receive Radiation Therapy at KMCH, Coimbatore

 

Vetrichelvi S. B.¹, Dhanasekar V. M², Anu C. Vijay³, Sathish Rajamani⁴

¹Nursing Officer, AIIMS, Mangalagiri.

²Senior Nursing Officer, AIIMS, Mangalagiri.

³Nursing Officer, AIIMS, Mangalagiri.

⁴Professor, Shri Anand Institute of Nursing, Rajkot.

 

ABSTRACT:

The aim of the present study was to evaluate the Effectiveness of Cryotherapy on Radiation Induced Oral Mucositis among patients who receive Radiation Therapy. The Methodology: Research design adopted for this study was quasi-experimental pre-test and post-test control group design. The subjects were randomized to two groups by preparing 30 lots. The lots were labelled as E which was assigned to Experimental group and C which was allocated to Conventional care group. The subjects were asked to pick a lot and based on that lot, the subjects were assigned to Experimental group and Conventional care group. The study was conducted in the Department of Radiation Oncology, Comprehensive Cancer Center at KMCH, Coimbatore. The sample size was 30 subjects. 15 subjects were assigned to each group. Non – Probability Purposive Sampling technique was adopted. Conceptual Framework was based on Modified Swanson’s Structure of Caring (1993). Cryotherapy was done by providing Ice cubes to the patient’s and instruct them to suck and rinse slowly and swish it around the mouth for 5 minutes and then spit it out. This was done 15 minutes before and after Radiation Therapy. Oral mucositis was assessed in both Experimental group  and Conventional care group at the end of 1^st, 2^nd, 3^rd, 4^th, 5^th and 6^th week after Radiation Therapy using WHO Oral Mucositis Grading Scale and Patient – Reported Oral Mucositis Symptoms [PROMS] scale. Results:  The Results of the study were by comparing the Oral Mucositis using WHO Oral Mucositis Scale at the end of each week between the Experimental group and Conventional care group, the ‘p’ value at the end of 2^nd, 3^rd, 4^th and 5^th week are 0.001, 0.05, <0.001 and 0.028 respectively and the p value for PROMS Scale is 0.022 which shows that there is a significant difference in Oral Mucositis Severity. Conclusion: In nutshell, the study recommends the use of cost effective Cryotherapy along with Soda – Bicarb mouth wash in Clinical Practice for patients who are receiving Head and Neck Radiation Therapy.

 

 

 

INTRODUCTION:

Radiation-induced oral mucositis (RIOM) is one of the major ionizing radiation toxicities and normal tissue injuries that result from radiotherapy¹.

 

 

RIOM was first termed in 1980 as a side effect of radiotherapy (RT) in cancer patients². RIOM is a normal tissue injury lasting between 7 and 98 days, which starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure^1,3.

 

Radiation-induced oral mucositis occurs in up to 80% of head and neck cancer irradiated patients and reaches up to 100% in patients with altered fractionation head and neck cancer. RIOM of grade 3 and 4 have been recorded in 56% of head and neck cancer patients treated with radiotherapy^1-4. Many risk factors have been identified for RIOM. These risk factors include concomitant chemotherapy (CT), bad oral hygiene, below average nutritional stratus, lack of antibiotic use at early stage mucositis, and smoking⁵.

 

Radiation-induced oral mucositis side effects and sequels include oral pain in 69% of patients, dysphagia in 56% of patients, opioid use in 53% of patients, weight loss of 3–7kg, feeding tube insertion and hospitalization (ICU admission) in 15% of patients, and modification or interruption of treatment in 11–16% of patients^6.7.

 

Mucositis is observed in 40% of standard-dose chemotherapies and more than 50% of high-dose chemotherapies. Especially in treatments that use drugs such as 5-Fluorouracil, (5-FU), Doxorubicin, Etoposide, Vinblastine, and Methotrexate this percentage can increase up to 90%⁸.

 

Numerous methods have been tested to cope with the side effects of chemotherapy, prevent opportunistic infections that may arise, and provide pain relief for the patient Cryotherapy is one of these methods Cryotherapy is the local cooling of tissues for treatment purposes that is an especially cheap, popular, and easy to use method for preventing mucositis caused by intravenous short-term chemotherapy agents and for decreasing their effects. When used together with short-term intravenous chemotherapy agents, cryotherapy causes local vasoconstriction and the blood flow to the oral mucosa slows down, the distribution of the drug among the cells decreases and, as a result, the risk of oral mucositis formation also decreases.

 

STATEMENT OF THE PROBLEM:

A Quasi–Experimental Study to Evaluate the Effectiveness of Cryotherapy on Radiation Induced Oral Mucositis among Patients who receive Head and Neck Radiation Therapy at KMCH, Coimbatore.

 

OBJECTIVES:

1.     To assess the Oral Mucositis Severity before Radiation therapy.

2.     To determine the effectiveness of Cryotherapy on Radiation Induced Oral Mucositis Severity after Radiation Therapy

3.     To associate the Radiation Induced Oral Mucositis Severity with selected Demographic and Clinical variables.

 

HYPOTHESES:

H1:   There will be a significant difference in Radiation Induced Oral Mucositis grade between Experimental group (Cryotherapy+Soda Bicarb mouth wash) and Conventional care group (Soda Bicarb mouth wash).

 

METHODOLOGY:

This study was based on quasi-experimental research design. Study settings was Department of Radiation Oncology at KMCH, Coimbatore. Radiation department offers both External Radiation Therapy and Internal Radiation Therapy. The sample size was 30 patients. 15 subjects were assigned to the Experimental group and 15 subjects were allocated to the Conventional care group. Sampling techniques was non – probability purposive sampling technique. Tool for data collection includes WHO Oral Mucositis Grading scale and Patient Reported Oral Mucositis Symptom (PROMS) Scale. Cryotherapy was given to subjects in Experimental group, from the day of enrolment till completion of their treatment. Soda bicarb mouth wash was given to all the subjects in both Experimental group and Conventional care group after development of oral mucositis.

 

RESULTS:

Table – I: Frequency and Percentage Distribution of Subjects According to Socio-Demographic Variables in Experimental and Control Group                                                                  (N = 30)

Sl. No	Demographic variables		Experimental group n = 15		Conventional care group n = 15
			(F)	%	(F)	%
1	Age in years	< 20	0	0	4	27
		21 to 40	0	0	2	13
		41 to 60	9	60	6	40
		>60	6	40	3	20
2	Sex	Male	13	87	9	60
		Female	2	13	6	40
3	Income in Rupees	Daily wager	1	7	0	0
		<5,000	1	7	1	7
		5,001 to 10,000	10	66	11	73
		>10,000	3	20	3	20
4	Education	Illiterate	4	27	2	13
		Primary	1	7	5	34
		Secondary	6	40	3	20
		Higher Secondary	2	13	2	13
		Graduate	2	13	3	20
5	Occupation	Student	0	0	3	20
		Employed	10	67	4	27
		Unemployed	2	13	7	46
		Retired	3	20	1	7

 

Table 1 shows the distribution of subjects according to the Demographic variables. Based on the Age in both the Experimental group [9 samples (60%)] as well as in the Conventional care group [6 samples (40%)], majority of the samples were in the age group of 41 to 60 years. According to Sex, majority of the samples in both the Experimental group [13 samples (87%) and Conventional care group [9 samples (60%)] were males. Based on the Income, majority of the samples in both Experimental group [10 samples (66%)] and Conventional care group [11 samples (73%)] were earning between Rs. 5,001 to 10,000. According to Education, in Experimental group [6 samples (40%)] had secondary education and in Conventional care group [5 samples (34%)] had primary education. Based on the Occupation, in Experimental group [10 samples (67%)] were employed and in Conventional care group [7 samples (46%)] were unemployed.

 

Table - II: Distribution of subjects according to their Clinical profile.                                                                                        (N = 30)

Sl. no	Clinical variables		Experimental group n=15		Conventional care group n=15
			Frequencies	%	Frequencies	%
1.	Site of cancer	Cancer Naso pharynx	0	0	1	6.6
		Cancer Oro pharynx	3	20	0	0
		Cancer Hypo pharynx	6	40	3	20
		Cancer Floor of mouth	1	6.6	0	0
		Cancer Tongue	0	0	1	6.6
		Cancer Soft palate	1	6.6	0	0
		Cancer Larynx	1	6.6	3	20
		Cancer Thyroid	0	0	3	20
		Ependymoma	0	0	2	13.3
		Medullo blastoma	0	0	1	6.6
		Brainstem glioma	0	0	1	6.6
		Fibrillary astrocytoma	1	6.6	0	0
		Oligodendroglioma	1	6.6	0	0
		Multiple myeloma	1	6.6	0	0
2.	Radiation dose	41 to 50 Gy	1	7	4	27
		51 to 60 Gy	4	27	4	27
		61 to 70 Gy	10	66	7	46
3.	Adjuvant therapies	RT only	3	20	4	27
		Chemotherapy +RT	10	67	9	60
		Post surgery + RT	2	13	2	13
		Post surgery + RT + chemotherapy	0	0	0	0

 

Table – III: Comparison of Radiation Induced Oral Mucositis severity using PROMS scale in each week in Experimental group and Conventional care group.                                                                                                                                                           (N =30)

S. no	Weeks	Groups				F value
		Experimental group n=15		Conventional care group n=15
		Mean	S. E	Mean	S.E	Between week	Between group
1.	Pre-test	0.00	0.00	0.00	0.00	43.512***	2.735*
2.	End of 1st week	0.20	0.05	2.67	0.21
3.	End of 2nd week	6.07	0.36	9.33	0.51
4.	End of 3rd week	11.00	0.65	17.73	1.05
5.	End of 4th week	13.50	0.62	23.00	1.25
6.	End of 5th week	17.86	0.76	30.80	1.44
7.	End of 6th week	21.86	0.93	37.33	1.83

***p-value<0.001, *p-value=0.022

 

Table – IV: Association of Radiation Induced Oral Mucositis with Selected Demographic and Clinical Variables in Experimental group and Conventional care group.                                                                                                                                                                  (N = 30)

S. No	Demographic Variables		Experimental group		Conventional care group
			χ2	p value	χ2	p value
1.	Age	<20 years	0.417	0.812 (NS)	13.333	0.038 (S)
		21 to 40 years
		41 to 60 years
		>60 years
2.	Sex	Male	2.019	0.364 (NS)	4.063	0.131 (NS)
		Female
3.	Income	Daily wager	9.250	0.160 (NS)	5.076	0.280 (NS)
		<5,000
		5,001 to 10,000
		>10,000
4.	Education	Uneducated	15.208	0.054 (NS)	15.083	0.058 (NS)
		Primary
		Secondary
		Higher secondary
		Graduate
5.	Occupation	Student	3.417	0.491 (NS)	10.908	0.091 (NS)
		Employed
		Unemployed
		Retired

 

Table 2 shows the distribution of subjects according to their Clinical variable. Among 15 samples in Experimental group 6 samples (40%) had cancer hypopharynx and in Conventional care group among 15 samples, 3 samples (20%) had cancer hypopharynx, 3 samples (20%) had cancer larynx, and 3 samples (20%) had cancer thyroid. Majority of subjects both in Experimental group and Conventional care group, 10 samples (66%) and 7 samples (46%) respectively received a Radiation dose of 61 to 70Gy. It is noted that both in Experimental group and Conventional care group, majority of patients 10 samples (67%) and 9 samples (60%) were receiving Chemotherapy along with Radiation therapy.

 

The above table shows that the obtained F value = 43.512 for Oral mucositis severity as the week progresses is significant at p<0.001. This clearly indicates that there is a significant increase in PROMS Scale score as the week progresses. The obtained ‘F’ value = 2.735 for comparison of Oral Mucositis severity between Experimental group and Conventional care group as the week progresses is significant at p = 0.022. This reveals that there is a significant difference in PROMS Scale score between the Experimental group and the Conventional group.

 

The above table shows that the p value for Radiation Induced Oral Mucositis Severity with demographic and clinical variables in Experimental group like Age (0.812), Sex (0.364), Income (0.160), Education (0.055), Occupation (0.491), Site of cancer (0.130), and radiation therapy dose (0.068) are not significant which reveals that there is no association between these variables and Radiation Induced Oral Mucositis, but the Adjuvant therapies (0.029) has a strong association with the Radiation Induced Oral Mucositis Severity. In the Conventional care group, the p value for Sex (0.131), Income (0.280), Education (0.058), Occupation (0.091) and Radiation dose (0.111) are not significant, which shows that there is no association between these variables and Radiation Induced Oral Mucositis Severity, but Age (0.038), Site of cancer (0.008) and Adjuvant therapies (0.003) have strong association with the Radiation Induced Oral Mucositis Severity.

 

DISCUSSION:

The present study finding is similar with the study conducted by Kakoei, S., Ghassemi, A & Nakhaei, N.R. (2013). The objective of their study was to investigate the effect of ice cubes on oral mucositis following head and neck radiotherapy. They have assessed for pain severity and oral mucositis grading using physician – judged oral mucositis grading and patient – judged oral mucositis grading. The results of their study showed that the p value (p = 0.155) for pain severity in Experimental group indicates that there is decrease in pain severity in the experimental group. The p value (p <0.001) for pain severity in the Control group reveals that pain severity was increased in control group. The p value for physician judged oral mucositis grading in both Experimental group (p <0.05) and the Conventional care group (p <0.001) which showed that there is no change in oral mucositis grade in both the groups. The p value for patient – judged oral mucositis grading in Experimental group was (p = 0.598) showed that there is no reduction in oral mucositis grading according to the patients. But in control group the p value for patient – judged oral mucositis grading was (p <0.01) which indicates that there is reduction in oral mucositis in control group according to the patients. They concluded that Cryotherapy can reduce pain severity and symptoms of oral mucositis, but it was not effective in improving the signs of oral mucositis.⁹

 

CONCLUSIONS:

The study results showed that Experimental group (Cryotherapy + Soda Bicarb mouth wash) had delay in development and reduction in severity of oral mucositis after Radiation therapy than the Conventional care group (Soda Bicarb mouth wash).Use of cost effective Cryotherapy along with Soda – Bicarb mouth wash can be recommended for patients who receive Head and Neck Radiation Therapy.

 

ETHICAL PERMISSION:

Approved by research ethical committee of KMCH College of Nursing, Coimbatore

 

REFERENCES:

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Received on 24.09.2021         Modified on 19.12.2021

Accepted on 21.02.2022       ©A&V Publications All right reserved