Nasopharyngeal CarcinomaNCT06248840
Intermittent Oral-esophageal Tube in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma
A study testing Intermittent Oral-esophageal Tube Feeding and nasogastric tube feeding in people with Nasopharyngeal Carcinoma, run by Zeng Changhao at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Intermittent Oral-esophageal Tube Feeding and nasogastric tube feeding
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2022
- 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
The Affiliated Hospital of Zhenzhou University
Zhenzhou, Hena, 450001
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Intermittent Oral-esophageal Tube Feeding, nasogastric tube feeding
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Oral-esophageal Tube FeedingDevice
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 feedingDevice
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.
| 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 health condition. The observation group receives IOE for enteral nutrition support Receives: Device: Intermittent Oral-esophageal Tube Feeding |
| 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 health condition.The control group receives NGT for enteral nutrition support Receives: Device: nasogastric tube feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Hemoglobin was recorded through the blood routine test. (Hb, g/L)
Measured: day 1 and day 15
Serum albumin
Serum albumin was recorded through the blood routine test. (ALB, g/L)
Measured: day 1 and day 15
Total serum protein
Total serum protein was recorded through the blood routine test. (TP, g/L)
Measured: day 1 and day 15
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 (4)
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
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 QOL.
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
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 start1 Jun 2022
- Primary completion25 Dec 2022
- Study completion31 Dec 2022
Why it stopped: ethical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Study chair, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248840
- Sponsor's protocol ID
- IOE-Biyanai jiu
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Intermittent Oral-esophageal Tube Feeding in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma: A Randomly Controlled Study
- ClinicalTrials.gov ID
- NCT06248840
- Acronym / sponsor ID
- IOE-Biyanai jiu
- Conditions
- Nasopharyngeal Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: ethical issues
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- 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 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.
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 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 FeedingDuring 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 |
| The control group | Active comparator | Device: nasogastric tube feedingDuring 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 |
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 FeedingDuring 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. | Device | The observation group |
| nasogastric tube feedingDuring 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. | Device | The control group |
Primary outcome
Hemoglobin
Time frame: day 1 and day 15
Hemoglobin was recorded through the blood routine test. (Hb, g/L)
Serum albumin
Time frame: day 1 and day 15
Serum albumin was recorded through the blood routine test. (ALB, g/L)
Total serum protein
Time frame: day 1 and day 15
Total serum protein was recorded through the blood routine test. (TP, g/L)
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
4 secondary outcomes
Depression
Time frame: day 1 and day 15
Swallowing-Quality of Life questionnaire
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
Results and safety
The study was stopped early (reason given: ethical issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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 study chair
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 and nasogastric tube feeding in people with Nasopharyngeal Carcinoma, run by Zeng Changhao 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: stopped early, as of the sponsor's last update on 7 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 stopped early (reason given: ethical issues). Results are not available in the source record.
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?
Hemoglobin (time frame: day 1 and day 15). The study lists 5 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 7 Mar 2024.