Clinical trial NCT03336775: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Keywords: acupuncure
dysphagia
radiation
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4.
timeFrame: Assessed at baseline and week 4 during acupuncture treatment.
Secondary outcomes:
measure: The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 16.
timeFrame: Assessed at baseline and 12 weeks post acupuncture treatment.
measure: 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.
timeFrame: Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
measure: The incidence of aspiration pneumonia change from baseline to week 4 and week 16.
timeFrame: Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
measure: The change of nutritional status from baseline to week 4 and week 16.
timeFrame: Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
measure: The percentage of necessary of nasogastric feeding and gastrostomy from baseline to week 16.
timeFrame: Assessed at baseline and 12 weeks post acupuncture treatment.
measure: The change of Quality of Life (QOL) scores from baseline to week 4 and week 16.
timeFrame: Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: yamei tang
role: STUDY_DIRECTOR
References: