DysphagiaNCT06248879
Intermittent Oro-esophageal Tube Feeding in Late Dysphagia for Nasopharyngeal Carcinoma
A study testing Intermittent Oral-esophageal Tube Feeding, Nasogastric Tube Feeding and comprehensive rehabilitation therapy in people with Dysphagia, run by People's Hospital of Zhengzhou University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Intermittent Oral-esophageal Tube Feeding, Nasogastric Tube Feeding and comprehensive rehabilitation therapy
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2024to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450001
About this study
Official title: A Randomly Controlled Study to Explore the Effect Intermittent Oro-esophageal Tube Feeding in Late Dysphagia for Nasopharyngeal Carcinoma
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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- Intermittent Oral-esophageal Tube Feeding, Nasogastric Tube Feeding, comprehensive rehabilitation therapy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Oral-esophageal Tube FeedingDevice
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 FeedingDevice
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.
comprehensive rehabilitation therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Nasogastric Tube Feeding; Behavioral: comprehensive rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of Hemoglobin
Hemoglobin was recorded through the blood routine test. (Hb, g/L)
Measured: day 1 and day 15
concentration of Serum albumin
Serum albumin was recorded through the blood routine test. (ALB, g/L)
Measured: day 1 and day 15
concentration of Serum prealbumin
Serum prealbumin was recorded through the blood routine test.(PA, g/L)
Measured: 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
Measured: day 1 and day 15
Secondary outcomes (5)
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.
Measured: day 1 and day 15
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).
Measured: day 1 and day 15
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.
Measured: day 1 and day 15
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.
Measured: day 1 and day 15
Feeding amount
The total amount of nutrients consumed by the patient on the day was recorded, excluding fresh water, units: milliliters
Measured: day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start28 Feb 2024
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: ethical issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Principal investigator, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248879
- Sponsor's protocol ID
- IOE-Biyanai-Xin
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomly Controlled Study to Explore the Effect Intermittent Oro-esophageal Tube Feeding in Late Dysphagia for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06248879
- Acronym / sponsor ID
- IOE-Biyanai-Xin
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: ethical issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- People's Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The observation group | Experimental | Device: Intermittent Oral-esophageal Tube Feeding, Behavioral: comprehensive rehabilitation therapyDuring 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 |
| The control group | Active comparator | Device: Nasogastric Tube Feeding, Behavioral: comprehensive rehabilitation therapyDuring 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Oral-esophageal Tube FeedingThe 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. | Device | The observation group |
| Nasogastric Tube FeedingNasogastric 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. | Device | The control group |
| comprehensive rehabilitation therapyBoth 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. | Behavioural | The control group, The observation group |
Primary outcome
concentration of Hemoglobin
Time frame: day 1 and day 15
Hemoglobin was recorded through the blood routine test. (Hb, g/L)
concentration of Serum albumin
Time frame: day 1 and day 15
Serum albumin was recorded through the blood routine test. (ALB, g/L)
concentration of Serum prealbumin
Time frame: day 1 and day 15
Serum prealbumin was recorded through the blood routine test.(PA, g/L)
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
5 secondary outcomes
Depression
Time frame: day 1 and day 15
Functional Oral Intake Scale
Time frame: day 1 and day 15
Penetration-Aspiration Scale
Time frame: day 1 and day 15
Swallowing-Quality of Life questionnaire
Time frame: day 1 and day 15
Feeding amount
Time frame: day 1 and day 15
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master principal investigator
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Oral-esophageal Tube Feeding, Nasogastric Tube Feeding and comprehensive rehabilitation therapy in people with Dysphagia, run by People's Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of Hemoglobin (time frame: day 1 and day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.