AcupunctureNCT03336775
Efficacy of Acupuncture in Radiotherapy-induced Dysphagia in Patients With Head and Neck Cancer
A study testing acupuncture in people with Acupuncture, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acupuncture
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2018to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Yamei Tang, M.D., Ph.D, +862034070569, yameitang@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Acupuncture
- Being tested
- acupuncture
- Keywords
- acupuncure, dysphagia, radiation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Acupuncture for 30 minutes per day for up to 20 sessions (over 4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: acupuncture |
| control | No intervention | Patients receive no acupuncture. The use of corticosteroid is the same with Arm I. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at baseline and week 4 during acupuncture treatment.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start21 Jun 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- yamei tang, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336775
- Sponsor's protocol ID
- 20160301
- Status last verified
- Jan 2020
- First submitted
- 12 Mar 2016
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture in Radiotherapy-induced Dysphagia in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03336775
- Acronym / sponsor ID
- 20160301
- Conditions
- Acupuncture
- Keywords
- acupuncure, dysphagia, radiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Procedure: acupuncturePatients 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. |
| control | No intervention | –Patients receive no acupuncture. The use of corticosteroid is the same with Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAcupuncture for 30 minutes per day for up to 20 sessions (over 4 weeks). | Procedure or surgery | acupuncture |
Primary outcome
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.
6 secondary outcomes
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 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 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 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 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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yamei tang study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Acupuncture, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamei Tang (+862034070569, yameitang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4. (time frame: Assessed at baseline and week 4 during acupuncture treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.