A Randomly Controlled Study to Explore the Effect of Oral Feeding in Dysphagia for Nasopharyngeal Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Serum albumin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Serum albumin
Time Frame: day 1 and day 15
Serum albumin was recorded through the blood routine test. (ALB, g/L)
Hemoglobin
Time Frame: day 1 and day 15
Hemoglobin was recorded through the blood routine test. (Hb, g/L)
Serum prealbumin
Time Frame: day 1 and day 15
Serum prealbumin was recorded through the blood routine test.(PA, g/L)
Body Mass Index
Time Frame: day 1 and day 15
Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ \[height (m)\] \^2
Secondary Outcomes
- Depression(day 1 and day 15)
- Penetration-Aspiration Scale(day 1 and day 15)
- Swallowing-Quality of Life questionnaire(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)
- Feeding amount(day 1 and day 15)
Investigators
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University