Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma
NCT ID: NCT06301763
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2023-01-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 health condition.The control group receives NGT for enteral nutrition support
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Muhammad
OTHER
Responsible Party
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Muhammad
Research Director
Principal Investigators
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Nieto Luis, Master
Role: PRINCIPAL_INVESTIGATOR
Site Coordinator of United Medical Group
Locations
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Afli Hospital
Zhongguo, , China
Countries
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References
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Zeng H, Zhao W, Zhang X, Wang X, Luo P, Li H, Wang L, Zeng X. How enteral nutrition modes influence nasopharyngeal carcinoma survivors with late dysphagia after radiotherapy: a randomized controlled study. Support Care Cancer. 2024 Oct 5;32(10):702. doi: 10.1007/s00520-024-08912-6.
Other Identifiers
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nosencekCancer-old
Identifier Type: -
Identifier Source: org_study_id
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