- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06189482
Intermittent Oral-esophageal Tube Feeding in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma (NPC)
March 8, 2024 updated by: Zeng Changhao
Clinical Observation of Intermittent Oral-esophageal Tube Feeding in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma: A Randomly Controlled Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Zheng da yi fu yuan hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18 and 65 years.
- With the history of NPC 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The observation group
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 IOE for enteral nutrition support
|
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 IOE for enteral nutrition support (developed by the Dysphagia Institute of Zhengzhou University, CN201821314797.2,
as shown in the Appendix), which is made of silicone material, 40 cm long, with an inner diameter of 0.54 cm.
Other Names:
|
Active Comparator: The control group
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 NGT for enteral nutrition support
|
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 is provided with nutritional support as NGT, 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin
Time Frame: day 1 and day 15
|
Hemoglobin was recorded through the blood routine test.
(Hb, g/L)
|
day 1 and day 15
|
Serum albumin
Time Frame: day 1 and day 15
|
Serum albumin was recorded through the blood routine test.
(ALB, g/L)
|
day 1 and day 15
|
Total serum protein
Time Frame: day 1 and day 15
|
Total serum protein was recorded through the blood routine test.
(TP, g/L)
|
day 1 and day 15
|
Serum prealbumin
Time Frame: day 1 and day 15
|
Serum prealbumin was recorded through the blood routine test.(PA,
g/L)
|
day 1 and day 15
|
Body Mass Index
Time Frame: day 1 and day 15
|
Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ [height (m)] ^2
|
day 1 and day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: day 1 and day 15
|
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
|
Swallowing-Quality of Life questionnaire
Time Frame: day 1 and day 15
|
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
|
Functional Oral Intake Scale
Time Frame: day 1 and day 15
|
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
|
Penetration-Aspiration Scale
Time Frame: day 1 and day 15
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nieto Luis, Doctor, Site Coordinator of United Medical Group located in Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
December 25, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
December 7, 2023
First Submitted That Met QC Criteria
December 19, 2023
First Posted (Actual)
January 3, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 8, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Esophageal Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Deglutition Disorders
Other Study ID Numbers
- 2022-KY-0049
- 2020-PT310-01 (Other Grant/Funding Number: Chinese academy of medical science)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to the privacy regulation of The First Affiliated Hospital of Zhengzhou University
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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