Clinical trial NCT06328868: Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma
Official title: A Randomly Controlled Study to Explore the Effect of Oral Feeding in Dysphagia for Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

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.

Eligibility 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
* 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.

Primary outcomes:
measure: Concentration of Hemoglobin
timeFrame: day 1 and day 15
measure: Concentration of Serum albumin
timeFrame: day 1 and day 15
measure: Body Mass Index
timeFrame: day 1 and day 15
measure: Concentration of Serum prealbumin
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Depression
timeFrame: day 1 and day 15
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 15
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 15
measure: Swallowing-Quality of Life questionnaire
timeFrame: day 1 and day 15
measure: Feeding amount
timeFrame: day 1 and day 15
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis
role: STUDY_CHAIR
References: