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

Last updated: January 17, 2020
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03336775
20160301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must have received radiation therapy for histologically confirmed head andneck 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-cellcount >/= 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, orconstant caregivers who well understand and willingness to sign a written informedconsent document.

Exclusion

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 needsurgery;

  3. History of seizures or bleeding related to tumor or radiotherapy during or after thecompletion 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 throatdisease, 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 congestiveheart 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 uncontrolledlife-threatening infection;

  7. Prior use of acupuncture for dysphagia;

  8. Enrolled in other clinical trials.

Study Design

Total Participants: 142
Study Start date:
June 21, 2018
Estimated Completion Date:
July 30, 2020

Study 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.

Connect with a study center

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

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.