ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study of Acupuncture Treatment for Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00797732
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Weidong Lu, Dana-Farber Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinomas, Squamous Cell Dysphagia Device: Acupuncture Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial
Study Start Date : December 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Active Comparator: Active Acupuncture
The active intervention used a three-phase step-up protocol to gradually increase the body areas treated and needling intensity. Acupuncture needles (0.20x25mm) were inserted with a depth of 5-10 mm into predefined points based on a systematic literature review following the STRICTA guideline. Needles were stimulated to obtain the de qi sensation. An electroacupuncture (EA) device was connected at two acupoints. All needles remained in place for 30 minutes. The active acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. [Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; MacPherson H, Altman DG et al. PLoS Med 2010;7:e1000261]
Device: Acupuncture
Sham Comparator: Sham Acupuncture
The sham intervention was designed to be maximally inert and minimally invasive, while simulating most aspects of the active protocol. Sham needles (0.12x30mm) were inserted at 14 locations paralleling the same body regions needled in the active group; however, all sham point locations were off the pathways of traditional Chinese medicine acupuncture meridians and points. An identical but deactivated EA device was used following sham protocols previously used. The sham acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. [Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005;86:2248-2255]
Device: Acupuncture



Primary Outcome Measures :
  1. Outcome Compliance Rate [ Time Frame: Assessed at baseline and at 6 months post acupuncture treatment ]
    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).

  2. Treatment Compliance Rate [ Time Frame: Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks) ]
    Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).


Secondary Outcome Measures :
  1. MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT) [ Time Frame: Assessed at baseline and 6 months post acupuncture which parallels 12 months post-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.

  2. MDADI Scores [ Time Frame: Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797732


Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Weidong Lu, MB, MPH, PhD Harvard Medical School/Dana-Farber Cancer Institute

Publications:
Responsible Party: Weidong Lu, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00797732     History of Changes
Other Study ID Numbers: 08-169
K01AT004415-01 ( U.S. NIH Grant/Contract )
DFCI-08169 ( Other Identifier: Dana-Farber Cancer Institute )
First Posted: November 25, 2008    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Weidong Lu, Dana-Farber Cancer Institute:
acupuncture
dysphagia
chemoradiation related effects
squamous cell carcinoma of the head and neck
nasopharyngeal cancer
oropharynx cancer
hypopharynx cancer
larynx cancer

Additional relevant MeSH terms:
Deglutition Disorders
Carcinoma, Squamous Cell
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell