Intermittent Oro-esophageal Tube Feeding in Late Dysphagia for Nasopharyngeal Carcinoma

Dysphagia Clinical Trial

Official title:

A Randomly Controlled Study to Explore the Effect Intermittent Oro-esophageal Tube Feeding in Late Dysphagia for Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06248879
• Other study ID #: IOE-Biyanai-Xin
• Status: Withdrawn
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• 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. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.

Description:

Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma continues to be a challenge. This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• 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
The specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux.
• Nasogastric Tube Feeding
Nasogastric Tube Feeding were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support.

Behavioral:
• comprehensive rehabilitation therapy
Both groups were given comprehensive rehabilitation therapy. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.

Locations

Country	Name	City	State
China	Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
People's Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of Hemoglobin	Hemoglobin was recorded through the blood routine test. (Hb, g/L)	day 1 and day 15
Primary	concentration of Serum albumin	Serum albumin was recorded through the blood routine test. (ALB, g/L)	day 1 and day 15
Primary	concentration of Serum prealbumin	Serum prealbumin was recorded through the blood routine test.(PA, g/L)	day 1 and day 15
Primary	Body Mass Index	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	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
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 quality of life.	day 1 and day 15
Secondary	Feeding amount	The total amount of nutrients consumed by the patient on the day was recorded, excluding fresh water, units: milliliters	day 1 and day 15