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NCT Number: NCT06301763

Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afli Hospital

Zhongguo, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent Oral-esophageal Tube Feeding

Device

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 health condition.The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support (developed by the Dysphagia Institute of Zhengzhou University, CN201821314797.2), which is made of silicone material, 40 cm long, with an inner diameter of 0.54 cm.

Nasogastric Tube Feeding

Device

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 health condition.The control group is provided with nutritional support as nasogastric tube feeding, performed 6-10 times per day according to relevant guidelines, with an interval of more than 2 hours between every two feedings, and a feeding volume not exceeding 200 ml per time.

Primary outcomes

  1. Hemoglobin Level

    Time frame: day 1 and day 15

    Hemoglobin was recorded through the blood routine test. (Hb, g/L)

  2. Serum albumin Level

    Time frame: day 1 and day 15

    Serum albumin was recorded through the blood routine test. (ALB, g/L)

  3. Total serum protein Level

    Time frame: day 1 and day 15

    Total serum protein was recorded through the blood routine test. (TP, g/L)

  4. Serum prealbumin Level

    Time frame: day 1 and day 15

    Serum prealbumin was recorded through the blood routine test.(PA, g/L)

  5. Body Mass Index Level

    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

  1. Depression

    Time frame: day 1 and day 15

    The PATIENT HEALTH QUESTIONNAIRE scale is utilized to evaluate the depression of patients at admission and after treatment. Options representing varying degrees of severity, ranging from 0 to 3 were provided in each aspect. The total scores between 0 and 4 were classified as negative, indicating the absence of depressive symptoms, while scores above 4 were classified as positive, indicating the presence of potential depressive symptoms.

  2. Swallowing-Quality of Life questionnaire

    Time frame: day 1 and day 15

    The Chinese version of the Swallowing-Quality of Life questionnaire (SWAL-QOL) was used to assess the quality of life of patients.he Likert scale ranging from 1 to 5 was utilized for scoring, with a total of 44 items, including difficulties in swallowing, dietary restrictions, oral health, social communication, and others. The total score was converted to a standard percentage scale ranging from 0 to 100, with positively correlated with QOL.

  3. Functional Oral Intake Scale

    Time frame: day 1 and day 15

    The Functional Oral Intake Scale (FOIS) was used to evaluate function of oral intake. In the FOIS assessment, two professional rehabilitation therapists communicated with the patients, observed and recorded to assess their swallowing function. The assessment scale consists of seven levels, with a higher level indicating progressively better swallowing function (less dysphagia).

  4. Penetration-Aspiration Scale

    Time frame: day 1 and day 15

    In this study, the Penetration-Aspiration Scale (PAS) was recruited, which was a commonly used to evaluate the occurrence of penetration or aspiration during swallowing. It categorizes dysphagia into eight levels, with Level 0 indicating no penetration or aspiration and Level 8 indicating severe aspiration. A higher level indicates more severe dysphagia.

Sponsors and collaborators

Lead sponsor

Muhammad

Other

Registry information

Official study title

Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma: A Randomly Controlled Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2024
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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