Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma

Dysphagia Clinical Trial

Official title:

Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma: A Randomly Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06301763
• Other study ID #: nosencekCancer-old
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Ahmadu Bello University Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 31, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Nasopharyngeal Carcinoma

Intervention

Device:
• 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 the health condition.The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support (developed by the Dysphagia Institute of Zhengzhou University, CN201821314797.2), which is made of silicone material, 40 cm long, with an inner diameter of 0.54 cm.
• 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 the health condition.The control group is provided with nutritional support as nasogastric tube feeding, performed 6-10 times per day according to relevant guidelines, with an interval of more than 2 hours between every two feedings, and a feeding volume not exceeding 200 ml per time.

Locations

Country	Name	City	State
China	Afli Hospital	Zhongguo

Sponsors (1)

Lead Sponsor	Collaborator
Muhammad

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin Level	Hemoglobin was recorded through the blood routine test. (Hb, g/L)	day 1 and day 15
Primary	Serum albumin Level	Serum albumin was recorded through the blood routine test. (ALB, g/L)	day 1 and day 15
Primary	Total serum protein Level	Total serum protein was recorded through the blood routine test. (TP, g/L)	day 1 and day 15
Primary	Serum prealbumin Level	Serum prealbumin was recorded through the blood routine test.(PA, g/L)	day 1 and day 15
Primary	Body Mass Index Level	Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ [height (m)] ^2	day 1 and day 15
Secondary	Depression	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.	day 1 and day 15
Secondary	Swallowing-Quality of Life questionnaire	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.	day 1 and day 15
Secondary	Functional Oral Intake Scale	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).	day 1 and day 15
Secondary	Penetration-Aspiration Scale	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.	day 1 and day 15