Effects of Swallowing Rehabilitation Training with a Balloon Dilation Therapy on the Deglutition Function and Quality of Life of Patients with Dysphagia after Radiotherapy for Nasopharyngeal Carcinoma.

Objective: The aim of this study is to investigate the effects of swallowing rehabilitation training with a balloon dilation therapy on the deglutition function and quality of life of patients with dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC).
Methods: The study was a retrospective study. The data of the 100 patients with dysphagia after NPC radiotherapy in our hospital between April 2021 and April 2022 were retrospectively analyzed. The patients were separated into the control group (n = 50) and experimental group (n = 50) according to their different treatments that were balloon dilation for the former and balloon dilation with swallowing rehabilitation training for the latter. The deglutition function, which was comprehensively evaluated by Kubota's water swallow test and assessments of penetration/aspiration and pharyngeal residue, and quality of life were compared between the two groups.
Results: The scores of Kubota's water swallow test, penetration aspiration scale (PAS), and Yale pharyngeal residue severity rating scale (YPR-SRS) in the experimental group after treatment were (2.04 ± 0.66), (2.92 ± 1.07), and (2.42 ± 0.90), respectively, which were remarkably lower than (2.58 ± 0.78), (4.38 ± 1.51), and (2.78 ± 0.86) in the control group, with distinct differences in the data between both the groups (P < 0.05). The quality of life of patients in the experimental group was distinctly better than that in the control group (P < 0.001).
Conclusion: Swallowing rehabilitation training in combination with a balloon dilation therapy can improve the deglutition function in patients with dysphagia after NPC radiotherapy as well as their quality of life, with a clinical application value.

1. Introduction

Nasopharyngeal carcinoma (NPC) is a malignant tumor of the head and neck originated from the mucosal epithelia of nasopharynx [1]. Epidemiological data show that the incidence of NPC is about 30/100,000–50/100,000, and the number of new cases is about 130,000 in 2018, mainly concentrated in Southeast Asia, with clinical characteristics such as high invasiveness and early metastasis [2, 3], and radiotherapy can effectively prolong the survival of patients. However, radiotherapy damages the normal tissues around the nasopharynx while killing tumor cells, and the radiation injuries cause harm to the oral mucosae, glands, and temporomandibular joints, resulting in tissue fibrosis, which can lead to symptoms such as difficulty in opening mouth and loss of appetite, and eventually to dysphagia [4, 5], whose incidence rate can reach up to 76%–100% in NPC patients treated with radiotherapy. Dysphagia not only seriously affects the eating function but may also induce aspiration pneumonia and endanger the life of patients [6], making targeted treatment a requisite for patients' lives and health. Despite being the most common treatment for dysphagia at this stage, balloon dilatation, and the convenient and cheap treatment standing out distinctly from the rest, can effectively improve the function of the cricopharyngeal muscle but is still confined to its single treatment site and poor stimulation to other muscle tissues [5, 7], which cannot improve the deglutition function of patients comprehensively and requires long-term and repeated performance in clinics. According to scholars Fong Raymond et al., swallowing rehabilitation training is necessary to improve dysphagia [8]. This training method is based on the principle of neuronal remodeling and nerve facilitation with the aim of improving the blood circulation capacity of swallowing organs through active and passive exercises of mouth-lips and tongue muscles, increasing the coordination of pharyngeal muscles, and assisting patients to reshape their normal swallowing patterns and gradually restore their deglutition function [9]. Based on the current phenomenon of dysphagia in NPC patients after radiotherapy, clinical treatment alone is no longer effective. Compared with balloon dilatation alone, the combination of swallowing rehabilitation training may speed the recovery of muscle function and elimination of dysphagia. Based on the fact that related research on the two treatments is scarce in academia, 100 patients with dysphagia after NPC radiotherapy were chosen for this study in order to investigate the practical effects of the combined application.

2. Materials and Methods

2.1. Research Design

This retrospective study was conducted at our hospital between April 2021 and April 2022 to investigate the effects of swallowing rehabilitation training with the balloon dilation therapy on the deglutition function and quality of life of patients with dysphagia after NPC radiotherapy. The study was double-blinded and neither the subjects nor the researchers were aware of the trail grouping. The study designer was responsible for arranging and controlling the entire trial.

2.2. General Data

The data of the 100 patients with dysphagia after NPC radiotherapy in our hospital between April 2021 and April 2022 were retrospectively analyzed. The patients were all with NPC stage II–IV by the American Joint Committee on Cancer [9] and underwent intensity modulated radiotherapy at a dose of 66–70 Gy, separated into the control group (n = 50) and experimental group (n = 50) based on their different treatments. In the experimental group, there were 33 males and 17 females, with a mean age of (50.38 ± 5.19) years, body mass of (60.65 ± 2.32) kg, BMI of (21.98 ± 1.25) kg/m2, disease duration of (5.04 ± 0.49) months, and clinical stage II in 8 cases, stage III in 29 cases, and stage IV in 13 cases. In the control group, there were 31 males and 19 females, with a mean age of (50.32 ± 5.24) years, body mass (60.74 ± 2.44) kg, BMI (22.01 ± 1.24) kg/m2, disease duration of (5.00 ± 0.49) months, and clinical stage II in 9 cases, stage III in 28 cases, and stage IV in 13 cases. The general data such as age, sex ratio, and disease duration were not remarkably different between the two groups (P > 0.05) and were of study value.

Inclusion criteria were as follows: (1) the patients who met the diagnostic criteria for NPC established by the American Joint Committee on Cancer and had dysphagia after radiotherapy, with symptoms such as hoarseness, difficulty eating, and salivation; (2) the patients who were treated at our hospital throughout the entire course of treatment without transfer; (3) the patients who had a Karnofsky performance score of ≥80; (4) the patients who had an expected survival of >3 months; and (5) the patients who were aged ≥18, with clear consciousness, stable vital signs, and were able to cooperate with the test. Exclusion criteria were as follows: (1) patients who were unable to communicate with others due to hearing disorders, speech disorders, unclear consciousness, mental illness, or other factors; (2) patients whose dysphagia was caused by cricopharyngeal achalasia revealed by fluoroscopy of swallowing; (3) patients with NPC recurrence; (4) patients who presented with dysphagia as the first symptom; (5) patients with oral or temporomandibular joint disease; (6) patients with severe cardiovascular diseases, acute infectious diseases, and acute attack of chronic diseases; (7) patients with other severe organic diseases; and (8) patients in pregnancy or lactation.

2.3. Moral Consideration

The study was in accordance with the Declaration of Helsinki (2013) [10]. The patients knew the purpose, significance, content, and confidentiality of the study and signed the informed consent.

2.4. Methods

The control group was treated with balloon dilation. Before dilation, a latex catheter, water, and a 10 ml syringe were prepared, and 1% tetracaine (Hunan Wzt Pharmaceutical Co., Ltd.; NMPA approval no. H20084317) was inserted into the patient's nostril with a cotton swab for local mucosal anesthesia. Water was injected into the catheter, filling the balloon whose integrity was checked, and then the water was withdrawn with the balloon set aside. The operator inserted the catheter through the nostril into the esophagus of patients so that it passed completely through the cricopharyngeal muscle. 10 ml of water was injected into the balloon of catheter with a syringe to expand its diameter to 2.2–2.7 cm, with the pintle held to prevent water backflow. The operator slowly pulled the catheter outward until it was stuck or could not be pulled, and then marked the position of nostril on the catheter as a reference point for the next dilation treatment. Subsequently, the operator drew a proper amount of water and pulled the balloon according to the tension of the cricopharyngeal muscle with a force that allowed the balloon through with a little resistance, where the balloon was fixed for about 120 s. After that, the operator gently lifted the catheter outward, and when there was a feeling of sliding or a sharp decrease in the resistance, which indicated the balloon had slipped through the cricopharyngeal muscle, the nursing staff was instructed to quickly withdraw the water from the balloon. The operator inserted the catheter to the cricopharyngeal muscle again and repeated the operation 5 times, once a day. The amount of water injected into the balloon was increased by 1 ml daily. After the procedure, the patients were given aerosol inhalation of dexamethasone (Golden Sun Pharmaceutical Co., Ltd., China, Xiamen; NMPA approval no. H20060241), α-chymotrypsin (Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.; NMPA approval no. H31022005), and gentamicin (Yichang Humanwell Pharmaceutical Co., Ltd.; NMPA approval no. H42022058) to avoid mucosal edema.

The experimental group was supplemented with swallowing rehabilitation training, with the following specific measures. (1) Active training: the patients were guided to open their mouth to the fullest extent and close after 5 s and then perform clicking teeth exercises by knocking their upper and lower rows of teeth gently, and move the mouth back and forth, left and right with the act of gum-chewing, with 30 times each exercise and 3 exercises a day. The patients were instructed to perform chewing, cheek puffing, and breath-holding exercise for 5 min each time, 3 times a day. The patients were instructed to bend and slowly rotate the head and neck to the left and right for 15 min each time, 3 times a day. The patient was guided to make empty swallowing movements while raising and lowering the head, with their tongue root, soft palate, and throat wall stimulated with frozen cotton swabs for 5 min each time, 3 times a day. (2) Passive training: the patients' temporomandibular joint was massaged along the direction of the muscle fibers, avoiding the area of skin breakdown caused by radiotherapy, for 15 min each time, twice a day. The tongue of the patients was wrapped with gauze and pulled in different directions for 5 min each time, twice a day. A mouth opener was selected according to the patients' mouth shape and placed in their mouth for support training with 5 min each time, twice a day, paying attention to keeping the oral muscles relaxed. Mendelsohn maneuver was used to guide the patients to take a deep breath and hold it with force. At the same time, the rehabilitation conductors used massage techniques to squeeze the patients' arytenoid cartilage with both hands forward and lift their throat. After several seconds, the patients were enabled to master the way of laryngeal elevation and sucking, and were assisted to carry out swallowing action. Then, the patients were asked to cough vigorously to complete the swallowing action on the glottis. Subsequently, the patients were asked to extend the tongue forward with the tongue root retracted with force. (3) Daily training: at eating time, the patients took a sitting or semi-recumbent position, and swallowing and empty swallowing were conducted alternately, with semiliquid food and liquid food, respectively, and each bite was chewed up slowly before next bite to fully train the swallowing skills.

2.5. Observation Standards

2.5.1. Deglutition Function

Kubota's water swallow test was proposed by Japanese scholar Toshio Kubota [11]. Before and after treatment, the patients were guided to drink 30 ml of warm water, and the time required for drinking was recorded, as well as any abnormal situations that occurred such as choking and coughing during that time. Scoring criteria: the patients who finished drinking within 5 s at one time without choking and coughing scored 1 point; the patients who took more than 5 s in one drinking, or in two times without choking and coughing scored 2 points; the patients who finished drinking at one time with choking or coughing scored 3 points; and the patients who needed to drink twice, unfinished drinking with choking or coughing scored 4 points. The scale was clearly graded and simple to use for patients with indications.

Penetration aspiration assessment [12]: referring to the penetration aspiration scale (PAS) of Rosenbek, and also depending on whether the boluses of food induced the cough reflex during swallowing and the amount of boluses coughed up, the scale was concise, clearly graded, and more visually reflected the patients' penetration, aspiration, and the severity serving as a guideline on physicians' development of rehabilitation treatment plans. The scoring criteria: a score of 1 indicated normal, with the boluses not entering the airway; 2–5 points represented penetration, in which 2 being the boluses entering the airway but remaining above the vocal cords without residue, and 5 being the boluses contacting the vocal cords with residue; 6–7 points was aspiration, with 6 being the boluses passing through the glottis without residue under the glottis, and 7 being the boluses passing through the glottis with residue under it and the patients responding; and 8 points was resting aspiration, with the boluses passing through the glottis with residue under it and the patients not responding.

Pharyngeal residue assessment [13]: the degree of food residue in the pharynx of patients was assessed with reference to the Yale pharyngeal residue severity rating scale (YPR-SRS). Scoring criteria: 1 point was no residue in the epiglottic valleculae and pyriform fossa; 2 points was traces of residue in the epiglottic valleculae and pyriform fossa; 3 points was residue in the epiglottic valleculae, with visible ligament and the contents filling 1/4 of the pyriform fossa; 4 points was residue in the epiglottic valleculae, with invisible ligament and the contents filling 1/2 of the pyriform fossa; 5 points was the contents filling the edge of the epiglottis and the aryepiglottic folds. Among them, 1–5 points corresponded to the degree of pharyngeal food residue as none, trace, mild, moderate, and severe.

2.5.2. Quality of Life

The evaluation of quality of life of patients based on the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) scale (V4.0), designed by Rush University Medical Center, America [14]. The scale included the Functional Assessment of Cancer Therapy-General (FACT-G) scale and the Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) scale, with five dimensions of physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional status (FWB), and additional concerns of head and neck subscale (HNS). Among them, GP1-GP7, GE1-GE6, HN2, HN3, HN6, HN8, and HN9 were inverse items and the rest were positive items. Cronbach's α for each dimension and each module of the scale ranged from 0.707 to 0.898, suggesting a high internal consistency among items. The higher the score of all dimensions, the better the quality of life.

2.6. Statistical Disposal

In this study, SPSS20.0 was chosen as the data-processing software and GraphPad Prism 7 (GraphPad Software, San Diego, USA) was chosen as the picture-drawing software . The research items were count data and measurement data, which were tested by χ2 and t tests and differences were statistically significant when P < 0.05.

3. Results

3.1. Comparison of the Deglutition Function

Before treatment, no remarkable difference was found in scores of Kubota's water swallow test between both groups (2.92 ± 0.63 vs 2.86 ± 0.63, P < 0.05). After treatment, the scores of Kubota's water swallow test in the experimental group were remarkably lower than those in the control group (2.04 ± 0.66 vs 2.58 ± 0.78, P < 0.001) as presented in Figure 1.

Figure 1

Comparison of scores of Kubota's water swallow test. (a) The scores before treatment; (b) the scores after treatment.

Before treatment, the scores of 1, 2, 3, and 4 were 0, 12, 30, and 8 cases in the experimental group and 0, 14, 29, and 7 cases in the control group. After treatment, the numbers were 10, 28, 12, and 0 in the experimental group and 4, 18, 23, and 5 in the control group.

Before treatment, no remarkable difference was found in PAS scores between both the groups (4.98 ± 1.41 vs 4.98 ± 1.39, P < 0.05). After treatment, the PAS scores in the experimental group were remarkably lower than those in the control group (2.92 ± 1.07 vs 4.38 ± 1.51, P < 0.001) as presented in Figure 3.

Figure 3

Comparison of YPR-SRS scores. (a) The scores before treatment; (b) the scores after treatment.

Before treatment, the scores of 1, 2, 3, 4, 5, 6, 7, and 8 were 0, 0, 10, 10, 11, 9, 10, and 0 cases in the experimental group and 0, 1, 8, 10, 12, 10, 9, and 0 cases in the control group. After treatment, the numbers were 5, 12, 18, 13, 1, 1, 0, and 0 in the experimental group and 2, 3, 10, 10, 13, 8, 4, and 0 in the control group.

Before treatment, no remarkable difference was found in YPR-SRS scores between both the groups (3.06 ± 0.93 vs 3.04 ± 0.87, P < 0.05). After treatment, the YPR-SRS scores in the experimental group were remarkably lower than those in the control group (2.42 ± 0.90 vs 2.78 ± 0.86, P < 0.05), as presented in Figure 2.

Figure 2

Comparison of PAS scores. (a) The scores before treatment; (b) the scores after treatment.

Before treatment, the scores of 1, 2, 3, 4, and 5 were 0, 15, 22, 8, and 5 cases in the experimental group and 0, 14, 24, 8, and 4 cases in the control group. After treatment, the numbers were 8, 18, 20, 3, and 1 in the experimental group and 3, 14, 26, 5, and 2 in the control group.

3.2. Comparison of Quality of Life

The quality of life of patients in the experimental group was distinctly better than that in the control group (P < 0.001) as presented in Table 1.

Table 1

Comparison of quality of life (‾x ± s, points).

Groups	PWBBefore/after treatment		SWBBefore/after treatment		EWBBefore/after treatment		FWBBefore/after treatment		HNSBefore/after treatment
Experimental group	20.28 ± 1.27	15.28 ± 1.15	12.30 ± 1.27	20.30 ± 1.17	19.34 ± 1.24	13.34 ± 1.27	12.32 ± 1.14	17.36 ± 1.28	11.78 ± 1.62	19.36 ± 1.21
Control group	19.74 ± 1.94	17.30 ± 1.22	12.38 ± 1.26	16.26 ± 1.28	19.38 ± 1.50	15.32 ± 1.27	12.34 ± 1.23	15.34 ± 1.18	11.72 ± 1.58	15.32 ± 1.24
t	1.647	8.519	0.316	16.473	0.145	7.795	0.084	8.205	0.187	16.489
P	0.103	<0.001	0.753	<0.001	0.885	<0.001	0.933	<0.001	0.852	<0.001

4. Discussion

Dysphagia refers to swallowing problems caused by the impaired structure and function of swallowing organs, which often happens to patients with head and neck malignant tumors after treatment, such as NPC, laryngeal cancer, and tongue cancer [15,16]. As the most prevalent head and neck cancer in China [17], high-dose radiotherapy is preferred for NPC. However, the radiation kills tumor cells while damaging the brainstem and lower cranial nerves, inducing ataxia and trends of fibrosis of masticatory muscles, pharyngeal constrictor muscles, and neck muscles with abnormal temporomandibular joint function, which eventually leads to dysphagia. According to epidemiological data, NPC patients are more than 75% likely to develop dysphagia after radiotherapy [18]. The disease will not only cause hypoproteinemia and malnutrition, but also increase the possibility of aspiration and consequent aspiration pneumonia, making patients undergo repeated anti-inflammatory and nutritional support therapies, which seriously declines their quality of life, and that is why scientific assessment of dysphagia and targeted treatments are significant measures of securing NPC patients' quality of life.

Balloon dilation, the most common clinical treatment for dysphagia currently [19], mainly consists of disposable balloon catheter dilation and multiple balloon catheter dilation. The latter was chosen in this study, that is, a procedure in which a water-fillable balloon with catheters of different diameters is inserted from top to bottom in the patients' cricopharyngeal muscle, whose function is restored by the gradual expansion of the balloon through its changed diameter due to the increasing dose of water injected [20]. Balloon dilatation has an ideal basis for promotion as a result of the ease of operation and low cost, whose therapeutic effects, however, usually takes long-term, repeated procedures to achieve. For example, Fong Raymond et al. have found in a study of patients with dysphagia that their cricopharyngeal muscle function improved sufficiently after an average of 19.7 surgeries of balloon dilatation, and some of them still had cricopharyngeal muscle weakness after 34 balloon expansions and had to rely on therapeutic feeding [21]. Long-term treatment will increase patients' mental and economic burdens and is not conducive to maintaining their emotional and social family functions, for which reason effective training of muscle groups in a short time is the key to improve the quality of life of NPC patients. The swallowing rehabilitation training selected in this study was based on the principle of neuronal remodeling, which improved the strength of patients' mastication and deglutition muscles through active and passive functional training of the mouth, tongue, and jaw and was conducive to enhancing the ability of oral muscles and neck muscles to push the boluses [22]. Therefore, the scores of Kubota' s water swallow test and assessment of pharyngeal residue in the experimental group were remarkably lower than those in the control group (P < 0.05), suggesting the enhanced ability of patients to control the boluses. Besides, the frozen swabs stimulated the sensitivity of the pharynx and soft palate to the food bolus, while pushing, massage, and Mendelssohn training maintained the stability of the internal pharyngeal pressure and enhanced the precursor force and retraction force of the tongue, thus reducing the possibility of penetration and aspiration. The study of Schreiber Ann-Marie et al. has further confirmed that swallowing function training can reduce the tissue fibrosis around the temporomandibular joint and relieve its stiffness and enhance its toughness, which contributes to a decreased level of inflammatory factors and accelerated rehabilitation process [23]. This study did not compare relevant indexes, which is a limitation. The combination of swallowing rehabilitation training and balloon dilatation effectively improved the treatment rate of dysphagia and reduced the psychological and physiological burden of patients, so the quality of life in the experimental group was distinctly higher than that in the control group (P < 0.001).

In view of the high clinical value of balloon dilation therapy and swallowing rehabilitation training in the patients with dysphagia after NPC radiotherapy, this study finally determines the combination of the two as a clinical protocol for treating dysphagia, whose therapeutic effect was objectively evaluated by several scales in expectation of the promotion and application in clinical treatment. As an effective protocol for improving deglutition dysfunction in such patients, its emergence can improve the patients' quality of life and benefit them and also provide a new idea for the treatment of dysphagia after NPC radiotherapy.