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

Primary Purpose

Acupuncture

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acupuncture focused on measuring acupuncure, dysphagia, radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

acupuncture

control

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 12, 2016
Last Updated
January 17, 2020
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03336775
Brief Title
Efficacy of Acupuncture in Radiotherapy-induced Dysphagia in Patients With Head and Neck Cancer
Official Title
Efficacy of Acupuncture in Radiotherapy-induced Dysphagia in Patients With Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVE Primary: To determine the therapeutic efficacy of acupuncture on radiotherapy-induced dysphagia in patients with head and neck cancer. Secondary: To determine whether acupuncture can improve swallow function in these patients. To determine what extent acupuncture can improve the complications of dysphagia of these patients, including the incidence of aspiration pneumonia, malnutrition. To determine what extent this traditional Chinese therapy can improve quality of life of these patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture
Keywords
acupuncure, dysphagia, radiation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
Patients receive no acupuncture. The use of corticosteroid is the same with Arm I.
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
Acupuncture for 30 minutes per day for up to 20 sessions (over 4 weeks).
Primary Outcome Measure Information:
Title
The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4.
Description
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.
Time Frame
Assessed at baseline and week 4 during acupuncture treatment.
Secondary Outcome Measure Information:
Title
The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 16.
Description
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.
Time Frame
Assessed at baseline and 12 weeks post acupuncture treatment.
Title
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.
Description
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.
Time Frame
Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
Title
The incidence of aspiration pneumonia change from baseline to week 4 and week 16.
Description
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.
Title
The change of nutritional status from baseline to week 4 and week 16.
Description
The change of nutritional status from baseline to week 4 and week 16. The nutritioanl status include the weight, BMI, albumin.
Time Frame
Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
Title
The percentage of necessary of nasogastric feeding and gastrostomy from baseline to week 16.
Description
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.
Title
The change of Quality of Life (QOL) scores from baseline to week 4 and week 16.
Description
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.
Time Frame
Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yamei Tang
Phone
+862034070569
Email
yameitang@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yamei tang
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamei Tang, M.D., Ph.D
Phone
+862034070569
Email
yameitang@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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