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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 16  |  Issue : 3  |  Page : 186-194

Using chamomile for alleviating oral mucositis among patients with head and neck cancer receiving radiotherapy


1 Department of Medical Surgical Nursing, Faculty of Medicine, Cairo University, Cairo, Egypt
2 Department of Clinical Oncology, Faculty of Medicine, Cairo University, Cairo, Egypt

Date of Submission15-Apr-2020
Date of Decision30-Apr-2020
Date of Acceptance04-May-2020
Date of Web Publication20-Aug-2020

Correspondence Address:
Asmaa M AbdElwadoud
Department of Medical Surgical Nursing, Faculty of Nursing, Cairo University, Cairo
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ENJ.ENJ_12_20

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  Abstract 


Background Radiotherapy-induced oral mucositis remains one of the main and most common adverse effects affecting all patients receiving radiotherapy for head and neck cancer (HNC).
Aim To evaluate the use of chamomile on alleviating oral mucositis among patients with HNC receiving radiotherapy.
Design A quasi-experimental nonequivalent control group interrupted time series design was utilized.
Research hypotheses H1: patients who receive chamomile gel will have a statistically significant difference regarding oral mucositis grade compared with the control group who receive only routine hospital care. H2: patients who receive chamomile gel will have statistically significant lower mean severity scores of pain intensity associated with oral mucositis compared with those who receive only routine hospital care. H3: patients who receive chamomile gel will have statistically significant lower mean severity scores of patient-reported oral mucositis symptoms compared with those who receive only routine hospital care.
Sample A convenient sample of 60 patients with HNC was recruited along 6 months.
Tools Four tools were used to collect data: Structured Interview Questionnaire, National Cancer Institute Scoring for Mucositis, Patient-Reported Oral Mucositis Symptoms Scale, and Pain Numeric Rating Scale-11.
Results In spite of the increase in oral mucositis grade among the study and the control groups, there was a statistically significant difference between both groups, and the increase in oral mucositis grade in the study group was significantly less than the control group. Moreover, there was a statistically significant difference in pain severity mean scores, as well as patient-reported oral mucositis symptom mean scores in favor of the study group that received chamomile gel compared with the control group that received only routine hospital care.
Conclusion Chamomile gel was effective in reducing oral mucositis grade, severity of pain, as well as patient-reported oral mucositis symptoms in the study group compared with the control group.

Keywords: chamomile, head and neck cancer, radiotherapy-induced oral mucositis


How to cite this article:
AbdElwadoud AM, Hassanein SM, El-Deen DS, Abdou I. Using chamomile for alleviating oral mucositis among patients with head and neck cancer receiving radiotherapy. Egypt Nurs J 2019;16:186-94

How to cite this URL:
AbdElwadoud AM, Hassanein SM, El-Deen DS, Abdou I. Using chamomile for alleviating oral mucositis among patients with head and neck cancer receiving radiotherapy. Egypt Nurs J [serial online] 2019 [cited 2020 Sep 30];16:186-94. Available from: http://www.enj.eg.net/text.asp?2019/16/3/186/292490




  Introduction Top


Head and neck cancer (HNC) is an accumulative term that refers to several varieties of malignant tumors that form in or around the areas of the throat, nose, sinuses, mouth, or larynx. HNC is the eighth most common cancer worldwide. There are more than 650 000 cases of HNC and 330 000 deaths worldwide annually (Bray et al., 2018). Surgery, chemotherapy, and radiotherapy are the main treatment modalities for HNC (Cillo et al., 2020). Despite the therapeutic role of radiotherapy for managing HNC, the associated acute adverse effects such as dysphagia, radiation dermatitis, xerostomia, oral mucositis, and neck lymphedema caused by radiotherapy are grave concerns for both patients and clinicians (Akiyama, 2017).

Radiation-induced oral mucositis (RIOM) remains one of the most common adverse effects of radiotherapy in HNC, as all patients who are treated by radiotherapy experience oral mucositis (Daugėlaitė et al., 2019). RIOM refers to epithelial damage that may occur on oral, pharyngeal, and laryngeal mucosa owing to the ionizing radiation exposure, mainly between the second and third week of conventional radiotherapy (Charalambous et al., 2018; Choi et al., 2020).

The management of oral mucositis is important for patient survival because it leads to interruption of radiotherapy. Therefore, Cho et al. (2015) highlighted that there is an urgent need for effective, well-tolerated, and available strategies to manage this condition. Moreover, the management of RIOM has strengthened the need for further investigation of other intervention, including complementary medicine such as naturally occurring compound owing to their lower adverse effects as compared with chemical drugs (Gomes et al., 2018).

Chamomile has been widely used in traditional and herbal treatment for a long time. The plant has chemical compounds such as chamazulene, alpha-bisabolol, bisaboloxides, spiroethers, and flavonoids that have anti-inflammatory, antibacterial, spasmolytic, sedative, and antifungal effects. It has been claimed to stimulate granulation and epithelialization, which result in normalization of the oral cavity and speeding up of re-epithelialization of oral tissues (Das, 2014; Aghamohamamdi and Hosseinimehr, 2016).

Oncology nurses are in a unique position to recognize, assess, monitor, and manage the symptoms of oral mucositis through their frequent contact with the patients, which allows nurses to assess risk and intervene with preventive strategies that have an important role in reducing incidence of RIOM among patients with HNC by using new modalities in the management of this condition such as chamomile. Thus, the aim of the current study was to evaluate the use of chamomile on alleviating oral mucositis among patients with HNC receiving radiotherapy.


  Significance of the study Top


The average numbers of patients with HNC admitted to the Centre of Radiation Oncology and Nuclear Medicine at a selected university hospitals in 2015, 2016, and 2017 were 149, 154, and 127 patients, respectively, according to Statistical Administration and Medical Records Department at the Centre of Radiation Oncology and Nuclear Medicine, at a Selected University Hospitals-Egypt (2017). Moreover, almost all of those patients had oral mucositis with different severity. Apparently RIOM has a negative effect on a patient’s life, as it results in pain, which leads to functional difficulties in eating, drinking, swallowing, and even sleeping. These effects can lead to weight loss, anorexia, and dehydration, which may arise the need for total parenteral nutrition, increase the duration of hospitalization, and discontinuation of treatment until oral mucositis healing occurs; all these complications result in economic and clinical consequences on the patient and the hospital as well as the health care system.

In spite of local and systemic traditional methods used to manage RIOM, none of these methods provide an effective and comprehensive management. Therefore, there is a significant need for using complementary medicine in the management of RIOM (Charalambous et al., 2018). Furthermore, chamomile is considered as one of the safest and effective natural remedies for RIOM.


  Materials and methods Top


Aim of the study

The aim of the current study was to evaluate the use of chamomile on alleviating oral mucositis among patients with HNC receiving radiotherapy.

Research hypotheses

H1: patients who receive chamomile gel will have a statistically significant difference regarding oral mucositis grade compared who the control group, who receive only routine hospital care.

H2: patients who receive chamomile gel will have statistically significant lower mean severity scores of pain intensity associated with oral mucositis compared with those who receive only routine hospital care.

H3: patients who receive chamomile gel will have statistically significant lower mean severity scores of patient-reported oral mucositis symptoms compared with those who receive only routine hospital care.

Research design

A quasi-experimental nonequivalent control group interrupted time series research design was used to achieve the aim of the current study.

Setting

The current study was conducted at the Centre of Radiation Oncology and Nuclear Medicine at a selected University Hospital, Egypt.

Sample

A convenient sample over 6 months of 60 male and female adult patients was eligible for the current study. Patients were randomly assigned into study and control groups (30 patients each). The following inclusion criteria were established: (a) diagnosed with HNC and (b) scheduled to receive first session of fractionated radiotherapy but not less than 6 weeks. The exclusion criteria were (a) patients who were receiving any other complementary therapy for mucositis, (b) patients experiencing allergic reaction against chamomile, and (c) patients with any oral surgical procedure or any other oral inflammation rather than oral mucositis.

Data collection tools

Four tools were used to collect data pertinent to the current study. Content validity of the used English and Arabic version tools was reviewed by a panel of jurists with expertise in the subject at the Medical Surgical Nursing Department from Faculty of Nursing, Cairo University.
  1. Structured Interview Questionnaire: it was developed by the researchers and included demographic data, which covered questions related to age, sex, etc.
  2. National Cancer Institute Scoring for Mucositis, version 4.03 (NCI-CTC V4.03): it was established by the National Cancer Institute (2009). It consists of five grades for assessing oral mucositis, ranged from 0 to 4: grade 0 means no oral mucositis, grade 1 reflects mild, grade 2 as moderate, grade 3 equals severe grade, and grade 4 is life-threatening. Tool reliability was constructed by Liuet al.(2012) as Cronbach’s alpha=0.86. After the Arabic translation, the researchers re-established the reliability, with highly significant result, as Cronbach’s alpha was 0.83.
  3. Patient-Reported Oral Mucositis Symptoms Scale: it was established by Kushneret al.(2008). It was used to assess the effect of oral mucositis on oral health function. It is a visual analog scale that includes 10 items, such as difficulty in eating hard food, mouth pain, and change in taste. There is a horizontal line 100 mm, and possible score for each question range between 0 and 100. The patients place a mark on the line that describes the degree of difficulty, where 0 equals no symptoms and 100 equals worst possible symptoms. The total score is 1000, with Cronbach’s alpha reliability of 0.98, as reported by Kushneret al.(2008). After Arabic translation, the researchers re-established its reliability, with highly significant result, as Cronbach’s alpha was 0.82.
  4. The Pain Numeric Rating Scale: it consists of a 11-point Likert scale from 0 to 10, adopted from McCaffery and Beebe (1989). It is a self-reported scale, as 0 means no pain, 1–3 mild pain, 4–6 moderate pain, and 7–10 severe pain. The reliability of the Pain Numeric Rating Scale was constructed by Ferrazet al.(1990), with Cronbach’s alpha of 0.94. After Arabic translation, the researchers reperformed the reliability, with highly significant result, as Cronbach’s alpha was 0.85.


Pilot study

A pilot study was performed on 10% of the study sample. There was no required modification done in the study tools, so sample of the pilot study was included in the study sample. The time required for filling in the data collection tools was estimated to be 15 min.

Ethical consideration

IRB (00004025) approval to conduct the proposed study was obtained from the Research Ethics Committee of Faculty of Nursing, Cairo University. Moreover, an official permission was obtained from hospital/clinic administrators to conduct the study. Participants who met the inclusion criteria and accepted to participate in the study were asked to sign an informed consent after explaining the aim and nature of the study. The researchers emphasized that participation in the study was voluntary, and anonymity and confidentiality were assured. Moreover, the researchers informed the participants that they have the right to withdraw from the study at any time after informing the researchers.

Procedure

The procedure was divided into three phases as follows: initial phase, implementation phase, and evaluation phase. In the initial phase, the researchers explained the aim and nature of the study to the participants who met the inclusion criteria, and they signed provided an informed consent. Thereafter, a patch test was done for all participants to ensure chamomile safety (Lawless, 2013). All participants who had a negative sensitivity test result were included in the current study. The researchers randomly assigned the enrolled participants into two equal groups, with 30 participants in each group. Both control and study groups took the same hospital regimen regarding management of oral mucositis, which was therapeutic oral gel or therapeutic oral rinsing. Then the researchers used all study tools for both control and study groups to have baseline data at the same time. In the implementation phase, the researchers explained in detail to the participants in the study group the intervention protocol regarding chamomile oral gel as follows: the participants were instructed to take 0.1 ml of this gel using insulin syringe for measuring the dose. The participants were instructed to use the gel three times a day, applying that gel 1 h before meals, and participants were instructed to avoid eating, drinking, or rinsing their mouths for 30 min afterward (Ardakani et al., 2016). The study group was instructed to use chamomile gel from the first session of the radiotherapy and continued until finishing the last session of the fractionated radiotherapy. For the sake of the participants’ commitment, the researchers handed for each participant a bottle of 30 ml of chamomile gel to be used at home. In the evaluation phase, follow-up of the participants in either the study or control group was performed using National Cancer Institute, Pain Numeric Rating Scale, and Patient-Reported Oral Mucositis Symptoms Scale at the end of every week over the 6 weeks.

Statistical design

The collected data were scored, tabulated, and analyzed by a personal computer using statistical package for the social science program, version 25 (Armank, New York, USA). Descriptive as well as inferential statistics were used to analyze the data pertinent to the study. Descriptive statistics including frequency distribution, means, and SD were used. Moreover, inferential statistics included independent t test and χ2 test. Level of significance was adopted at P value less than or equal to 0.05.


  Results Top


Findings of the current study are presented in two sections: section I is geared toward demographic characteristics and medical related data ([Figure 1] and [Figure 2]), whereas section II presents the findings related to the study hypotheses ([Table 1],[Table 2],[Table 3]).
Figure 1 Percentage distribution of oral mucositis grade of the study and control groups along study period (N=60).

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Figure 2 Percentage distribution of patient-reported oral mucositis symptoms of the study and control groups along study period (N=60).

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Table 1 Comparison between study and control groups regarding mean pain score along the study period (N=60)

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Table 2 Comparison between total mean score of patient-reported oral mucositis symptoms of the study and control groups along the study period (N=60)

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Table 3 Comparison between study and control groups regarding oral mucositis grades along the study period (N=60)

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Section I

Demographic characteristics of patients among studied patients

Regarding age, 43.3% of both study and control groups had age equal or more than 60 years, whereas 26.7% of the study group had age in the range from 45 to less than 60 years, and 30% of the control group had age ranged between 30 to less than 45 years. The mean age of participants in the study and control groups was 53.9±16.6 and 54.4±15 years, respectively. It was found that 80 and 83.3% were male, 90 and 93.3% were married, 30 and 40% cannot read and write, 40 and 36.7% had primary education, 70 and 76.7% were from rural area, and 60 and 40% were not employed among study and control groups, respectively. Additionally, there was no statistically significant difference between the study and control groups regarding demographic data.

[Figure 1] illustrates that 16.7% of the study group and 83.3% of the control group had mild oral mucositis in the third week. In relation to fourth week, it was found that 46.7% of the study group had no oral mucositis, whereas 43.3% of the control group had moderate oral mucositis. Moreover, 50% of the study group had mild oral mucositis, whereas 30% of the control group had severe oral mucositis in the sixth week.

[Figure 2] shows that, 46.7 and 83.3% of both study and control groups had mild oral mucositis symptoms in the fourth week, respectively. With reference to fifth week, 6.7 and 56.7% of both study and control groups had moderate oral mucositis symptoms, respectively. Furthermore, 26.7% of the study group had moderate oral mucositis symptoms compared with 70% of the control group in the sixth week.

Section II

[Table 1] illustrates that at the end of the second week, there was no statistically significant difference between study and control groups in relation to pain severity, as t test=1.24, P value=0.219. However, by the end of the third, fourth, fifth, and sixth weeks, there were statistically significant differences between the study and control groups, as t test=4.1, P value=0.000; t test=3.92, P value=0.000; t test=3.29, P value=0.002; and t test=2.51, P value=0.015, respectively.

[Table 2] reveals that at the end of the second week, there was no statistically significant difference between study and control groups in relation to patient-reported oral mucositis symptoms (t test=0.38, P value=0.70). However, by the end of the third, fourth, fifth, and sixth weeks, there were statistically significant differences between study and control groups (t test=3.7, P value=0.000; t test=4.6, P value=0.000; t test=4.4, P value=0.000; and t test=3.4, P=0.001, respectively).

[Table 3] exhibits that at the end of the second, third, fourth, and fifth week, there were statistically significant differences between study and control groups in relation to oral mucositis grades (c2=8.69, P=0.025; c2=27.6, P=0.000; c2=19.28, P=0.000; and c2=9.22, P=0.01, respectively). However, by the sixth week, there was no statistically significant difference between study and control groups (c2=4.36, P=0.1).


  Discussion Top


RIOM occurs in 100% of HNC (Daugėlaitė et al., 2019). Chamomile contains chemical structures such as chamazulene, alpha-bisabolol, bisaboloxides, spiroethers, and flavonoids that have anti-inflammatory, antibacterial, spasmolytic, sedative, and antifungal effects, which lead to normalization of the oral cavity and enhance re-epithelialization of oral tissue (Aghamohamamdi and Hosseinimehr, 2016).

Regarding the study sample characteristics, the study findings showed there was no statistically significant difference between study and control groups in relation to demographic data, so homogeneity was ensured before initiation of the intervention. The current study revealed that almost half of the participants’ age was more than 60 years, which was consistent with Saraiya et al. (2020) who conduct a study on 1170 participants in California entitled ‘The association between diet quality and cancer incidence of the head and neck’ and found that approximately half of the participants had age more than 60 years. Moreover, pooled data from seven case–control studies (3844 cases; 6824 controls) participating in the International Head and Neck Cancer Epidemiology consortium revealed that merely half of the participants had age more than 60 years (De Vito et al., 2019). Indeed this finding reflects that occurrence of HNC increases with increasing age (Vigneswaran and Williams, 2014).

Regarding sex, the current study showed that the male participants’ percentage was higher than female participants, which represented most of the sample. This finding was consistent with Takiar et al. (2016), DemirDoğan et al. (2017), Lai et al. (2018), and Mlak et al. (2018), where all affirmed that male was the predominant sex. In addition, HNC develops more common in male than female (Rennie et al., 2020).

Regarding patients’ marital status, it was found that the most of the study participants were married. These findings were relatively congruent with Paek et al. (2018), who conduct a study about ‘Contextual and stress process factors associated with HNC caregivers’ physical and psychological well‐being’ and found that most study participants were married. Another study carried out by Choi et al. (2016) on 622 participants entitled ‘Socioeconomic and other demographic disparities predicting survival among HNC patients’ revealed that most participants were married. Moreover, another survey study conducted by Simpson et al. (2019) on 71 799 participants concluded that more than half of the participants were married.

In relation to educational level, more than one-third of the participants had primary education level. These findings were consistent with Rigoni et al. (2016) who reported that half of the participants had primary education; furthermore, Stanford-Moore et al. (2018) denoted that more than one-third of the participants had primary education. However, this finding did not agree with Butler et al. (2017) who pointed out that merely one-third had secondary education level.

With reference to employment status, it was found that two-thirds of the study group and merely half of the control group were not employed, including both retired and who had no work. These findings were relatively congruent with Jabbour et al. (2017), who conducted a survey in Australia entitled ‘Education and support needs in patients with HNC: a multi-institutional survey’ and found that around half of the participants were retired. On the contrary, this finding did not agree with Tribius et al. (2018), who found that around half were employed.

Concerning place of residence, most participants were from rural area. This finding was consistent with Agarwal et al. (2018), who conduct a study on 156 participants and found that most participants were from a rural area. On the contrary, this finding did not agree with Walker et al. (2017), who pointed out that the majority were from urban areas.

In relation to the study findings related to research hypotheses, regarding pain severity, the researchers found differences between the study and control groups starting from the third week, with the highest difference observed on the third week, which might reflect that the efficiency of chamomile gel, which needs at least three consecutive weeks to show its effects, and the benefit of this regimen was continued to the end of the sixth week, but it decreased a little bit, which was expected owing to the cumulative effect of radiotherapy. The study conducted by Lopez Jornet and Aznar‐Cayuela (2016) on ‘Efficacy of topical chamomile management versus placebo in patients with oral lichen planus: a randomized double‐blind study’ concluded that there was a significant difference in the pain severity after 4 weeks in the chamomile group compared with the control group.

In relation to patient-reported oral mucositis symptoms, the researchers found that there were statistically significant differences between study and control group starting from the third week, and the highest difference was observed on the fourth week. The researchers interpret this finding as chamomile contains chemical constitute such as chamazulene, alpha-bisabolol, bisaboloxides, spiroethers, and flavonoids that possess anti-inflammatory, antibacterial, spasmolytic, sedative, and antifungal effects. Another study carried out by Ardakani et al. (2016) entitled ‘Evaluating the effect of Matricaria recutita and Mentha piperita herbal mouthwash on the management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized, double blind, placebo controlled clinical trial’ concluded that there was a decrease in oral mucositis symptoms in chamomile group compared with control group.

Moreover, in relation to oral mucositis grade, it was revealed that there were significant differences between study and control group, starting from the second week, with the highest difference being observed on the third week, which might be owing to the anti-inflammatory properties of chamomile gel, and the benefit of this regimen was continued to the end of the sixth week, but it was decreased a little bit, which was expected because of radiotherapy. Another study performed by Motaghi et al. (2017) entitled ‘Comparative effect of chamomile mouthwash and topical mouth rinse in prevention of chemotherapy-induced oral mucositis in Iranian pediatric patients with acute lymphoblastic leukemia’ revealed that there was a significant decrease in oral mucositis grade in chamomile group compared with control group on 14 days after chemotherapy, with a highly significant difference.


  Conclusion Top


The results of the current study revealed that there was a statistically significant difference in oral mucositis grade, pain intensity, and patient-reported oral mucositis symptoms in the study group compared with the control group, so chamomile was effective in the reduction of oral mucositis grade, severity of pain, as well oral mucositis symptoms among patients with HNC. Therefore, based on the current research finding, apparently the researchers can confidently accept the research hypotheses which supported the idea of using chamomile gel in enhancing the cure of oral mucositis, which can consequently decrease the pain induced from oral inflammation.

Nursing implication

This regimen is beneficial for patient with HNC, as it was safe and none of the study participants experienced sensitivity reaction.

Recommendations

The following recommendations could be suggested from the results of the current study:
  1. Replication of the study on a larger probability sample selected from different geographical areas in Egypt.
  2. Conducting another study to find out the effect of chamomile on chemotherapy-induced oral mucositis.
  3. Expand the use and the measurement of chamomile after stopping radiotherapy.
[37]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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