Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00797732
Other study ID # 08-169
Secondary ID K01AT004415-01DF
Status Completed
Phase N/A
First received November 21, 2008
Last updated January 16, 2018
Start date December 2008
Est. completion date August 2015

Study information

Verified date January 2018
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current standard of care for advanced HNC is concurrent chemoradiation therapy (CRT), which has led to increased survival rates, but with significant acute and long-term toxicities. Dysphagia, or difficulty with swallowing, is a common and expected side effect during and following CRT. Dysphagia occurs in up to 50% of patients and significantly impairs the quality of life (QOL) of patients during delivery of and recovery from CRT. Clinical trials evaluating promising and innovative adjunctive approaches that could increase the rate and magnitude of recovery from dysphagia in HNC patients are needed. Acupuncture is a traditional Chinese medical technique that has been found to reduce symptoms and side effects associated with primary cancer therapy. This study evaluated the feasibility of conducting a randomized sham-controlled trial and collected preliminary data on safety and efficacy of acupuncture.


Description:

AIMS:

Aim 1. To assess the feasibility of recruiting and retaining HNC patients with dysphagia into a randomized sham-controlled trial of acupuncture.

Aim 2. To collect preliminary data on the efficacy of acupuncture in changing scores of HRQOL in post CRT head and neck cancer patients.

Aim 3. (Exploratory) In a subset of HNC subjects treated with both active and sham acupuncture, to collect objective measures on swallowing functions using Videofluoroscopic swallowing study (VFSS); salivary flow production; and plasma Transforming Growth Factor (TGF)-β1, Interleukin 6 (IL-6), Tumor necrosis factor-alpha (TNF-α) and Interleukin 13 levels.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date August 2015
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically or cytologically proven squamous cell carcinoma of the head and neck (SCCHN) at stage II, III and IV, without evidence of distant metastasis. Stage I disease will also be permitted if the patient is receiving CRT;

- Primary tumor sites eligible: nasopharyngeal, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary squamous cell carcinoma (SCC) in the neck will also be eligible. SCC of the oral cavity will also be eligible with the approval of the treating staff;

- Receiving chemoradiation;

- Currently or recently undergoing swallowing therapy program with or without feeding tube use, with or without neck dissection;

- Age = 18 years;

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

- Adequate hematological function: neutrophil count >1.0 x109/L, platelet count >50x109/L

- Signed informed consent.

Exclusion Criteria

Patients with the following criteria will NOT be eligible for the study:

- Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;

- Wearing a pacemaker or implantable cardioverter-defibrillator;

- History of significant neurologic disorder that affects swallowing, including stroke, neurodegenerative disease, advanced dementia, or uncontrolled seizure disorder;

- Active clinically significant uncontrolled infection;

- Prior use of acupuncture for dysphagia;

Study Design


Intervention

Device:
Acupuncture


Locations

Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lu W, Posner MR, Wayne P, Rosenthal DS, Haddad RI. Acupuncture for dysphagia after chemoradiation therapy in head and neck cancer: a case series report. Integr Cancer Ther. 2010 Sep;9(3):284-90. doi: 10.1177/1534735410378856. Epub 2010 Aug 16. — View Citation

Lu W, Wayne PM, Davis RB, Buring JE, Li H, Goguen LA, Rosenthal DS, Tishler RB, Posner MR, Haddad RI. Acupuncture for dysphagia after chemoradiation in head and neck cancer: rationale and design of a randomized, sham-controlled trial. Contemp Clin Trials. 2012 Jul;33(4):700-11. doi: 10.1016/j.cct.2012.02.017. Epub 2012 Mar 2. — View Citation

Lu W, Wayne PM, Davis RB, Buring JE, Li H, Macklin EA, Lorch JH, Burke E, Haddad TC, Goguen LA, Rosenthal DS, Tishler RB, Posner MR, Haddad RI. Acupuncture for Chemoradiation Therapy-Related Dysphagia in Head and Neck Cancer: A Pilot Randomized Sham-Controlled Trial. Oncologist. 2016 Dec;21(12):1522-1529. Epub 2016 Aug 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Outcome Compliance Rate Outcome compliance rate is the percentage of enrolled participants who completed the primary study assessments (at baseline and in long-term follow-up 6 months post acupuncture treatment). Assessed at baseline and at 6 months post acupuncture treatment
Primary Treatment Compliance Rate Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions). Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks)
Secondary MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT) The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline. Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT
Secondary MDADI Scores The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline. Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03711474 - Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal) Phase 4
Enrolling by invitation NCT04074356 - Non-invasive Markers of Esophageal Function in Adults N/A
Suspended NCT04349462 - Post Critical Illness Dysphagia in the Intensive Care Unit N/A
Not yet recruiting NCT05982977 - Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT03455608 - PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer N/A
Active, not recruiting NCT03604822 - Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS N/A
Recruiting NCT03682081 - Interventions for Patients With Alzheimer's Disease and Dysphagia N/A
Completed NCT05700838 - Refining Cough Skill Training in Parkinson's Disease and Dysphagia Phase 1
Not yet recruiting NCT04064333 - Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care N/A
Not yet recruiting NCT02724761 - Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion N/A
Completed NCT02927691 - Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial Phase 2
Completed NCT01919112 - Fostering Eating After Stroke With Transcranial Direct Current Stimulation N/A
Completed NCT01370083 - Tongue Pressure Profile Training for Dysphagia Post Stroke Phase 2
Completed NCT01723358 - Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia Phase 2
Withdrawn NCT01200147 - Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation N/A
Completed NCT00570557 - Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia N/A
Recruiting NCT00166751 - Sonographic Assessment of Laryngeal Elevation N/A
Completed NCT00717028 - Functional Endoscopic Evaluation of Swallowing N/A
Completed NCT01476241 - Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist N/A