Clinical trial NCT06301763: Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma
Official title: Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma: A Randomly Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

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: Hemoglobin Level
timeFrame: day 1 and day 15
measure: Serum albumin Level
timeFrame: day 1 and day 15
measure: Total serum protein Level
timeFrame: day 1 and day 15
measure: Serum prealbumin Level
timeFrame: day 1 and day 15
measure: Body Mass Index Level
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Depression
timeFrame: day 1 and day 15
measure: Swallowing-Quality of Life questionnaire
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
Other outcomes:
Locations:
city: Zhongguo
country: China
facility: Afli Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References: