Clinical trial NCT06248879: Intermittent Oro-esophageal Tube Feeding in Late Dysphagia for Nasopharyngeal Carcinoma
Official title: A Randomly Controlled Study to Explore the Effect Intermittent Oro-esophageal Tube Feeding in Late Dysphagia for Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dysphagia
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 0
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: SUPPORTIVE_CARE

Brief 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. 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.

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: concentration of Hemoglobin
timeFrame: day 1 and day 15
measure: concentration of Serum albumin
timeFrame: day 1 and day 15
measure: concentration of Serum prealbumin
timeFrame: day 1 and day 15
measure: Body Mass Index
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:
city: Zhengzhou
country: China
facility: Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References: