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Trial Title:
Effect of Oral Enteral Nutrition in Nasopharyngeal Carcinoma Survivors With Swallowing Disorders
NCT ID:
NCT06301672
Condition:
Dysphagia
Conditions: Official terms:
Nasopharyngeal Carcinoma
Deglutition Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Nasogastric Tube Feeding
Description:
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.
Arm group label:
Nasogastric Tube Feeding
Intervention type:
Device
Intervention name:
Intermittent Oral-esophageal Tube Feeding
Description:
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.
Arm group label:
Intermittent Oral-esophageal Tube Feeding
Intervention type:
Behavioral
Intervention name:
comprehensive rehabilitation therapy
Description:
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.
Arm group label:
Intermittent Oral-esophageal Tube Feeding
Arm group label:
Nasogastric Tube Feeding
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age between 30 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.
Gender:
All
Minimum age:
30 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
March 2024
Completion date:
August 2024
Lead sponsor:
Agency:
Muhammad
Agency class:
Other
Source:
Ahmadu Bello University Teaching Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06301672
