Using a new nutrition tube for swallowing difficulties in nasopharyngeal cancer patients
A Randomly Controlled Study to Explore the Effect of Oral Feeding in Dysphagia for Nasopharyngeal Carcinoma
This study tests if a new type of feeding tube can help nasopharyngeal cancer patients with swallowing difficulties get better nutrition and improve their quality of life compared to the traditional feeding tube.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | People's Hospital of Zhengzhou University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06265844 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intermittent oro-esophageal tube feeding (IOE) compared to traditional nasogastric tube feeding (NGT) in patients experiencing delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC). It is a prospective multicenter study where participants are randomly assigned to either the observation group receiving IOE or the control group receiving NGT, alongside conventional care. The study evaluates various factors including nutritional status, quality of life, and any adverse events before and after treatment. The aim is to determine if IOE provides better support for patients' nutritional needs and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a history of nasopharyngeal carcinoma and delayed dysphagia occurring at least three years post-radiotherapy.
Not a fit: Patients with other diseases causing dysphagia, severe systemic disorders, or those who have received tube feeding in the past three years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve nutritional support and quality of life for patients suffering from dysphagia after NPC treatment.
How similar studies have performed: While traditional nasogastric feeding is common, the use of intermittent oro-esophageal tube feeding is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hong Kong
- Saint Martin Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Hongji Zeng, Master
- Email: 535226944@qq.com
- Phone: 17695841016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.