Impact of early dysphagia intervention on swallowing function and quality of life in head and neck cancer patients treated with intensity-modulated radiation therapy or image guided radiation therapy with or without surgery/chemotherapy

Introduction

Dysphagia is a very common problem associated with head and neck cancer patients. In spite of best of technologies like intensity modulated radiotherapy (IMRT) or image guided radiotherapy (IGRT), dysphagia remains a major problem in the locally advanced head and neck cancer patients. It can be due to the primary disease affecting the organ of swallowing or due to the treatment related sequelae.^[1] Surgery or radiation therapy with or without concurrent chemotherapy are the mainstays of treatment for head and neck cancer. Swallowing problems after head and neck surgery depends on the extent of resection, specific structures resected and type of reconstruction.^[2,3,4] It has been postulated that high radiation doses received by dysphagia and aspiration related structures (DARS) leads to swallowing muscle dysfunction and fibrosis, which appears to be the primary reason for swallowing dysfunction after radiotherapy. Common treatment-related sequelae are dysphagia, aspiration pneumonia, respiratory complications, malnutrition, change in voice and poor quality of life (QOL). Despite organ preservation through chemo-radiation, swallowing dysfunction is seen in more than 50% of patients. There is evidence of continued deterioration of swallowing function after chemo-radiation due to fibrosis in swallowing musculature. More than 50% patients have posttreatment dysphagia; 23–43% will have chronic dysphagia. Similarly, 20–40% of patients will have silent aspiration leading to pneumonia and repeated hospitalization.^{[5,6,7,8,9,10,11,12,13]} Available data in the literature indicate that swallowing rehabilitation can improve outcomes and it also depicts that early intervention appears to be superior to delayed intervention.^[14,15,16] We searched the available literature to find some other ways to reduce the rate of dysphagia. We found few publications mentioning some exercises which help in the improvement of swallowing function. We combined additionally these dysphagia exercises in one of the treatments arm (Group-A) to see their impact on chronic dysphagia, the risk of aspiration and QOL.

Materials and Methods

This study was carried out at the Department of Radiation Oncology jointly with Department of Physiotherapy and Rehabilitation (dysphagia unit) and Department of Ear, Nose, Throat (E.N.T.). The study was approved by the scientific committee and Institutional Ethics Committee. It has been registered at Clinical Trials Registry India.

This is a prospective randomized controlled trial conducted with the help of Department of Research and Statistics and was monitored by an independent monitoring committee to rule out any bias. Head and neck cancer patients, including all subsites and all stages (I–IV) with proven biopsy or histopathology reports were taken into this study after informed consent. Of 50 patients, 24 patients underwent surgery followed by adjuvant radiation. Six patients received concurrent chemotherapy also in this group. Radical radiotherapy with concurrent chemotherapy was given in 23 patients, and radical radiotherapy alone was given in 3 patients. Concurrent chemotherapy was given on weekly basis, single drug either cisplatin or carboplatin where indicated. In this study, we treated all our patients with modern conformal techniques like IMRT/IGRT with constraints to DARS, as mentioned by Eisbruch et al. in their various publications.^[13] Patients were treated with a dose of at 60–64 Gy; 66–68 Gy and 70 Gy in postoperative, radical RT along with concurrent chemotherapy or without chemotherapy respectively with conventional fractionation of 1.8–2 Gy/fraction, 5 days a week. All patients were treated on a linear accelerator (6 MV) with IMRT technique.

We randomized these 50 head and neck cancer patients, treated at Max Cancer Centre between August 2012 and January 2014 into two groups, 25 patients in Group-A and 25 in Group-B. Randomization charts were computer generated tables, provided by the Department of Research and Statistical analysis. After informed consent, patients were randomized into two groups. In Group-A, dysphagia interventions were provided from the day of the onset of radiation therapy and continued until 6 months whereas in Group-B no dysphagia interventions were given. Dysphagia intervention consisted of following exercises which were provided by a certified, designated dysphagia and occupational therapist: (1) Jaw exercise (2) tongue exercise, (3) the Mendelsohn maneuver, (4) shaker exercises, (5) supraglottic exercises (6) tongue hold, (7) mouth opening exercise, (8) range of motion (ROM) exercises. Patients were trained for these exercises and instructed to do at least twice a day, ten repetitions of each, from the 1^st week of radiation and to continue for a period of 6 months, after completion of radiation therapy. Patients demographics and treatment details are given in Table 1.

Dysphagia assessment along with the outcome measures was done for all patients. We used M.D. Anderson Dysphagia Inventory (MDADI) which is a validated and reliable questionnaire designed specifically for evaluating the impact of dysphagia on QOL in head and neck cancer patients. American Speech-language Hearing Association (ASHA) scale was used for assessing swallowing function. Penetration aspiration scale (PAS) was used to assess aspiration during swallowing with the help of fiberoptic endoscopic evaluation of swallowing (FEES). This was done by E.N.T. surgeon. After informed consent and assessment, the patients in Group-A were taught swallowing exercises and baseline score of ASHA, MDADI and PAS were assessed. Patients were asked to come at the end of 3^rd and 6^th month for follow-up in which again detailed dysphagia assessment with the score of ASHA, MDADI, PAS were assessed and exercises were reviewed. Group-B patients were also called at the end of 3^rd and 6^th months, but only dysphagia assessment and score of ASHA, MDADI, and PAS were recorded without any exercises.

Results

Acute mucositis was the commonest acute toxicity which necessitated Ryle's tube or PEG insertion in 15 patients (30%). 17 patients (34%) had an interruption in their radiation requiring hospitalization for a median of 3 days (range: 1–8 days). QOL was assessed using MDADI score. It was significantly better in exercise arm (Group-A). Patients had better QOL in terms of social eating, interaction with family members regarding eating habits and better self-esteem. MDADI score of each patient was noted at baseline and 6 months after treatment. Then mean value of each group was compared using independent samples test (Levene's test and t-test for equality of means). The MDADI score showed significant improvement from the baseline to 6 months in exercise arm, that is, Group-A (14 vs. 7.76, P = 0.017) [Figure 1].

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Figure 1

The M.D. Anderson Dysphagia Inventory score showed significant improvement from the baseline to 6 months in Group-A as compared to Group-B (14 vs. 7.76, P = 0.017)

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ASHA scale was used to assess how much nutritional needs were fulfilled by oral eating. Does patient needs some supervision while swallowing, whether any special technique or modification in food habits is required. ASHA score of each patient was noted at 6 months after treatment. Then mean value of each group was compared using independent samples test (Levene's test and t-test for equality of means). ASHA score also recorded statistical significance in favor of exercise arm (6.44 vs. 5.8, P = 0.002) [Figure 2]. Patients in Group-A were able to swallow almost normally by the end of 6 months. Patients in Group-B were able to meet their nutritional needs but required occasional support or modifications in their dietary habits (soft diet or liquids with solid food items) [Figure 2].

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Figure 2

American Speech Language Hearing Association score showing statistical significance in favor of exercise arm that is, Group-A (6.44 vs. 5.8, P = 0.002)

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Penetration and aspiration were evaluated during swallowing with the help of a fiberoptic endoscope. During initial workup, we found that six patients (12%) were having PAS score two, suggesting the risk of silent aspiration [Figure 3]. These patients were advised not to eat orally and were put on Ryle s/PEG tube, to minimize the risk of aspiration. The risk of silent aspiration, as evaluated by PAS score at the end of 3 months, was 36% (Group-A = 16%, Group-B = 20%). At the end of 6 months, it improved to 24% (Group-A = 8%, Group-B = 16%) [Table 3]. There was a trend toward lesser incidence of aspiration in exercise arm, but it was not statistically significant (P = 0.21) as shown in Figure 4. The risk of aspiration can be reduced by feeding tubes. However, prolonged tube feeding may induce severe psychological distress because it causes discomfort and distorts patient's self-image.^[23]

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Figure 3

Fiberoptic endoscopic evaluation of swallowing showing penetration aspiration scale score = 2 with risk of aspiration

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Figure 4

Lesser “aspiration” in exercise arm, but statistically not significant (P = 0.21)

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Patients in exercise arm were able to swallow more variety of food items; there were lesser dysphagia, better cough reflex and lesser incidences of aspiration at 6 months.

Discussion

After the encouraging results from this study, we have made a policy to send all head and neck cancer patients for dysphagia assessment and training for dysphagia prevention exercises within 1^st week of starting radiotherapy. In a patient having the slightest doubt about the risk of aspiration we advise for upfront NG tube or PEG tube placement. We encourage these patients to do regular dysphagia aspiration prevention exercises throughout the course of radiation therapy. In our study we found six patients (12%) to have risk for silent aspiration upfront, which increased to 36% at the end of 3 months posttreatment, at the end of 6 months it improved to 24%. We analyzed aspiration risk in exercise arm versus standard treatment arm, there was a trend toward lesser aspiration risk in exercise arm at 6 months (8% vs. 16%, P = 0.21) [Table 3]. There are various studies showing aspiration rate in head and neck cancer patients in the range of 15–80%^{[24,25,26,27]} [Table 4].

Nguyen et al.^[12] have reported 17% aspiration rate at the baseline evaluation, which increased to 59% posttreatment. 9% patient had sepsis and severe pneumonia and ultimately died. If you remove patients with baseline aspiration due to the disease itself, even then around 42% patient developed aspiration pneumonia posttreatment. Similarly, Stenson et al.^[28] have reported aspiration rate in the range of 30–67% in their patients with head and neck cancer.

Conclusion

Results from this study demonstrated that swallowing exercise, if administered from 1^st week of chemo-radiation and continued until 6 months, results in significant improvement in swallowing function and QOL. It can prevent much dysphagia-related complications and repeated hospitalization in head and neck cancer patients. Although longer follow-up with number of patients is required.