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

January 17, 2020 updated by: Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4.
Time Frame: Assessed at baseline and week 4 during acupuncture treatment.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 16.
Time Frame: Assessed at baseline and 12 weeks post acupuncture treatment.
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.
Time Frame: Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
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.
Time Frame: 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.
Time Frame: 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 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.
Time Frame: Assessed at baseline 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.
The change of Quality of Life (QOL) scores from baseline to week 4 and week 16.
Time Frame: Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: yamei tang, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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