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

NCT06248879 | Withdrawn

• 1 other identifier: IOE-Biyanai-Xin
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (4)

• concentration of Hemoglobin

  Hemoglobin was recorded through the blood routine test. (Hb, g/L)

  day 1 and day 15

• concentration of Serum albumin

  Serum albumin was recorded through the blood routine test. (ALB, g/L)

  day 1 and day 15

• concentration of Serum prealbumin

  Serum prealbumin was recorded through the blood routine test.(PA, g/L)

  day 1 and day 15

• 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 Outcomes (5)

• Depression

  day 1 and day 15

• Functional Oral Intake Scale

  day 1 and day 15

• Penetration-Aspiration Scale

  day 1 and day 15

• Swallowing-Quality of Life questionnaire

  day 1 and day 15

• Feeding amount

  day 1 and day 15

Study Arms (2)

The observation group

EXPERIMENTAL

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 patients; health condition. The observation group receives Intermittent Oro-esophageal Tube Feeding for enteral nutrition support

Device: Intermittent Oral-esophageal Tube Feeding; Behavioral: comprehensive rehabilitation therapy

The control group

ACTIVE COMPARATOR

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 patients; health condition.The control group receives nasogastric tube for enteral nutrition support

Device: Nasogastric Tube Feeding; Behavioral: comprehensive rehabilitation therapy

Interventions

Intermittent Oral-esophageal Tube Feeding DEVICE

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.

The observation group

Nasogastric Tube Feeding DEVICE

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.

The control group

comprehensive rehabilitation therapy BEHAVIORAL

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.

The control group; The observation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• People's Hospital of Zhengzhou University: lead

Study Sites (1)

Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450001, China

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: February 28, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)