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

NCT03336775 | Unknown

• 1 other identifier: 20160301
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acupuncture

Keywords

acupuncure; dysphagia; radiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 16.

  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.

  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.

  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.

  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.

  Assessed at baseline and 12 weeks post acupuncture treatment.

Study Arms (2)

acupuncture

EXPERIMENTAL

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

control

NO INTERVENTION

Patients receive no acupuncture. The use of corticosteroid is the same with Arm I.

Interventions

acupuncture PROCEDURE

Acupuncture for 30 minutes per day for up to 20 sessions (over 4 weeks).

acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have received radiation therapy for histologically confirmed head and neck cancer;
• Prior irradiation \>/= 6 months prior to study entry;
• Age\>/= 18 years;
• 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;
• 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.

You may not qualify if:

• Evidence of metastatic disease or tumor recurrence, tumor invasion to major vessels (e.g. the carotid);
• Evidence of very high intracranial pressure that suggests brain hernia and need surgery;
• History of seizures or bleeding related to tumor or radiotherapy during or after the completion of radiation;
• History of coagulation defects or allergy history of contrast agent;
• 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;
• 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;
• Prior use of acupuncture for dysphagia;
• Enrolled in other clinical trials.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• yamei tang

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Yamei Tang

CONTACT

+862034070569; yameitang@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes, inclduing VDS, rosenbek Penetration-Aspiration Scale scores, opening of upper esophageal sphincter(UES) and excursion of hyoid bone would be evaluated by two radiologists with blind method.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2016
• First Posted: November 8, 2017
• Study Start: June 21, 2018
• Primary Completion: April 30, 2020
• Study Completion: July 30, 2020
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)