Efficacy of Acupuncture in Radiotherapy-induced Dysphagia in Patients With Head and Neck Cancer

Purpose:

Rationale: Acupuncture is a therapy for physical activity disorders secondary to nervous diseases, and it may have therapeutic effects on dysphagia caused by radiation therapy.

Purpose: This randomized trial aims to investigate whether acupuncture may alleviate radiation-induced dysphagia in patients with head and neck cancer. The effect was compared with outcomes in patients without receiving acupuncture.

Study Overview

• Status: Unknown
• Conditions: Acupuncture
• Intervention / Treatment: Procedure: acupuncture

Detailed Description

OBJECTIVE

Primary:

To determine the therapeutic efficacy of acupuncture on radiotherapy-induced dysphagia in patients with head and neck cancer.

Secondary:

1. To determine whether acupuncture can improve swallow function in these patients.
2. To determine what extent acupuncture can improve the complications of dysphagia of these patients, including the incidence of aspiration pneumonia, malnutrition.
3. To determine what extent this traditional Chinese therapy can improve quality of life of these patients.
4. To evaluate the safety of acupuncture in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive acupuncture for 30 minutes per day for up to 20 sessions (over 4 weeks). These patients also received corticosteroid for 4 weeks, methylprednisolone 80mg ivdrip. for 3 days, 60mg ivdrip. for 3 days, 40mg ivdrip. for 3 days, 30mg po. for 7 days, 20mg po. for 7 days, 10mg po. for 5 days and maintain. Patients undergo VFSS before, at end of therapy (week 4) and 3 months (week 16) after therapy. Swallowing function, outcomes of dysphagia, including incidence of aspiration pneumonia, nutritional status change, and QOL change are assessed at baseline, week 4 and week 16.

Arm Ⅱ: Patients receive corticosteroid only, and the use of corticosteroid is the same with Arm I. Patients undergo VFSS before, at end of therapy (week 4) and 3 months (week 16) after therapy. Swallowing function, outcomes of dysphagia, including incidence of aspiration pneumonia, nutritional status change, and QOL change are assessed at baseline, week 4 and week 16.

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yamei Tang; Phone Number: +862034070569; Email: yameitang@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Yamei Tang, M.D., Ph.D; Phone Number: +862034070569; Email: yameitang@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must have received radiation therapy for histologically confirmed head and neck cancer;
2. Prior irradiation >/= 6 months prior to study entry;
3. Age>/= 18 years;
4. Routine laboratory studies with bilirubin </=2 * upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) < 2 * ULN, creatinine <1.5 * ULN, red-cell count >/= 4,000 per cubic millimeter; white-cell count >/=1500 per cubic millimeter, platelets >/= 75,000 per cubic millimeter; PT, APTT, INR in a normal range;
5. Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Evidence of metastatic disease or tumor recurrence, tumor invasion to major vessels (e.g. the carotid);
2. Evidence of very high intracranial pressure that suggests brain hernia and need surgery;
3. History of seizures or bleeding related to tumor or radiotherapy during or after the completion of radiation;
4. History of coagulation defects or allergy history of contrast agent;
5. History of disorder that affects swallowing, including brain stroke, oral or throat disease, malignances diseases, infection of the nervous system, demyelinating disease, neurodegenerative disease, advanced dementia, diabetes, peripheral vascular disease, HIV infection, familial degenerative peripheral neuropathy;
6. Severe complications: 1) New York heart association grade II or greater congestive heart failure; 2) Serious and inadequately controlled cardiac arrhythmia; 3) Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection); 4) Clinically significant peripheral vascular disease; 5) significant uncontrolled life-threatening infection;
7. Prior use of acupuncture for dysphagia;
8. Enrolled in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture; Patients receive acupuncture for 30 minutes per day for up to 20 sessions (over 4 weeks). These patients also received corticosteroid for 4 weeks, methylprednisolone 80mg ivdrip. for 3 days, 60mg ivdrip. for 3 days, 40mg ivdrip. for 3 days, 30mg po. for 7 days, 20mg po. for 7 days, 10mg po. for 5 days and maintain.	Procedure: acupuncture; Acupuncture for 30 minutes per day for up to 20 sessions (over 4 weeks).
No Intervention: control; Patients receive no acupuncture. The use of corticosteroid is the same with Arm I.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4.	The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4. VDS, according to result of Video Fluoroscopy Swallowing Study (VFSS), used as an objective and quantifiable predictor of recovery of the swallowing function. A videofluoroscopic dysphagia scale (VDS) with a sum of 100 was made according to the odds ratios of prognostic factors. The validity of the scale was evaluated by using a receiver operating characteristic curve. The VDS was compiled using the following 14 items: lip closure, bolus formation, mastication, apraxia, tongue-to-palate contact, premature bolus loss, oral transit time, triggering of pharyngeal swallow, vallecular residue, laryngeal elevation, pyriform sinus residue, coating of pharyngeal wall, pharyngeal transit time, and aspiration. At a scale cutoff value of 47. The higher the VDS score, the worse the swallowing function.	Assessed at baseline and week 4 during acupuncture treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 16.	The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 16. VDS, according to result of Video Fluoroscopy Swallowing Study (VFSS), used as an objective and quantifiable predictor of recovery of the swallowing function. A videofluoroscopic dysphagia scale (VDS) with a sum of 100 was made according to the odds ratios of prognostic factors. The validity of the scale was evaluated by using a receiver operating characteristic curve. The VDS was compiled using the following 14 items: lip closure, bolus formation, mastication, apraxia, tongue-to-palate contact, premature bolus loss, oral transit time, triggering of pharyngeal swallow, vallecular residue, laryngeal elevation, pyriform sinus residue, coating of pharyngeal wall, pharyngeal transit time, and aspiration. At a scale cutoff value of 47. The higher the VDS score, the worse the swallowing function.	Assessed at baseline and 12 weeks post acupuncture treatment.
The change of rosenbek Penetration-Aspiration Scale scores, opening of upper esophageal sphincter(UES) and excursion of hyoid bone from baseline to week 4 and week 16.	The rosenbek Penetration-Aspiration Scale(PAS) scores, opening of upper esophageal sphincter(UES) and excursion of hyoid bone will be assessed according to the VFSS to objectively evaluate the swallowing function. Penetration defined as passage of the bolus content into the laryngeal vestibule above the vocal cords. When food crossed the vocal cords and entered the airways, it was considered aspiration. Records were taken of the moment aspiration occurred (before onset of pharyngeal swallow, during pharyngeal contraction, or after swallowing). Consideration was also given to the appearance or not of cough during aspiration. Silent aspiration was defined as the entry of food below the level of the true vocal cords, without cough or any outward sign of difficulty. The PAS score with a total of 8, and >2 is considered to be abnormal. The higher the PAS score, the worse the swallowing function.	Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
The incidence of aspiration pneumonia change from baseline to week 4 and week 16.	The incidence of aspiration pneumonia change from baseline to week 4 and week 16.	Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
The change of nutritional status from baseline to week 4 and week 16.	The change of nutritional status from baseline to week 4 and week 16. The nutritioanl status include the weight, BMI, albumin.	Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
The percentage of necessary of nasogastric feeding and gastrostomy from baseline to week 16.	The percentage of necessary of nasogastric feeding and gastrostomy from baseline to week 16.	Assessed at baseline and 12 weeks post acupuncture treatment.
The change of Quality of Life (QOL) scores from baseline to week 4 and week 16.	The change of Quality of Life (QOL) scores from baseline to week 4 and week 16. The WHOQOL-BREF instrument comprises 26 items, which measures the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF (Field Trial Version) produces a quality of life profile. It is possible to derive four domain scores. The four domain scores denote an individual's perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.	Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Director: yamei tang, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: March 12, 2016
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: radiation; dysphagia; acupuncure
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Head and Neck Neoplasms; Deglutition Disorders
• Other Study ID Numbers: 20160301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No