Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma
- Conditions
- Dysphagia
- Interventions
- Device: Intermittent Oral-esophageal Tube FeedingDevice: nasogastric tube feeding
- Registration Number
- NCT06301763
- Lead Sponsor
- Muhammad
- Brief Summary
This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.
- Detailed Description
Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- Age between 18 and 65 years.
- With the history of Nasopharyngeal Carcinoma and radiation therapy.
- With dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support.
- Conscious and with stable vital signs;
- Willing to participate and sign the written informed consent form either personally or by a family member.
- Presence of other diseases that might cause dysphagia.
- With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies.
- Concurrent participation in other treatments that could interfere with the trial.
- Inability to cooperate with treatment due to aphasia, mental health issues, etc.
- Received tube feeding for enteral nutrition support within the past three years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent Oral-esophageal Tube Feeding Intermittent Oral-esophageal Tube Feeding During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on health condition. The observation group receives IOE for enteral nutrition support.54 cm. nasogastric tube feeding nasogastric tube feeding During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on health condition.The control group receives NGT for enteral nutrition support
- Primary Outcome Measures
Name Time Method Hemoglobin Level day 1 and day 15 Hemoglobin was recorded through the blood routine test. (Hb, g/L)
Serum albumin Level day 1 and day 15 Serum albumin was recorded through the blood routine test. (ALB, g/L)
Total serum protein Level day 1 and day 15 Total serum protein was recorded through the blood routine test. (TP, g/L)
Serum prealbumin Level day 1 and day 15 Serum prealbumin was recorded through the blood routine test.(PA, g/L)
Body Mass Index Level day 1 and day 15 Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ \[height (m)\] \^2
- Secondary Outcome Measures
Name Time Method Depression day 1 and day 15 The PATIENT HEALTH QUESTIONNAIRE scale is utilized to evaluate the depression of patients at admission and after treatment. Options representing varying degrees of severity, ranging from 0 to 3 were provided in each aspect. The total scores between 0 and 4 were classified as negative, indicating the absence of depressive symptoms, while scores above 4 were classified as positive, indicating the presence of potential depressive symptoms.
Swallowing-Quality of Life questionnaire day 1 and day 15 The Chinese version of the Swallowing-Quality of Life questionnaire (SWAL-QOL) was used to assess the quality of life of patients.he Likert scale ranging from 1 to 5 was utilized for scoring, with a total of 44 items, including difficulties in swallowing, dietary restrictions, oral health, social communication, and others. The total score was converted to a standard percentage scale ranging from 0 to 100, with positively correlated with QOL.
Functional Oral Intake Scale day 1 and day 15 The Functional Oral Intake Scale (FOIS) was used to evaluate function of oral intake. In the FOIS assessment, two professional rehabilitation therapists communicated with the patients, observed and recorded to assess their swallowing function. The assessment scale consists of seven levels, with a higher level indicating progressively better swallowing function (less dysphagia).
Penetration-Aspiration Scale day 1 and day 15 In this study, the Penetration-Aspiration Scale (PAS) was recruited, which was a commonly used to evaluate the occurrence of penetration or aspiration during swallowing. It categorizes dysphagia into eight levels, with Level 0 indicating no penetration or aspiration and Level 8 indicating severe aspiration. A higher level indicates more severe dysphagia.
Trial Locations
- Locations (1)
Afli Hospital
🇨🇳Zhongguo, China