Intermittent Oral-esophageal Tube Feeding in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma (NPC)

Zeng Changhao

Status: Terminated

Conditions: Dysphagia; Nasopharyngeal Carcinoma

Treatments: Device: Intermittent Oral-esophageal Tube Feeding; Device: nasogastric tube feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06189482

2020-PT310-01 (Other Grant/Funding Number)

2022-KY-0049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

The observation group

Experimental group

Description:

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 patients\' health condition. The observation group receives IOE for enteral nutrition support

Treatment:

Device: Intermittent Oral-esophageal Tube Feeding

The control group

Active Comparator group

Description:

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 patients\' health condition.The control group receives NGT for enteral nutrition support

Treatment:

Device: nasogastric tube feeding