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A Pilot Study of Acupuncture Treatment for Dysphagia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00797732
First Posted: November 25, 2008
Last Update Posted: November 1, 2017
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.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Weidong Lu, Dana-Farber Cancer Institute
  Purpose

This study is a pilot randomized, sham-controlled trial of acupuncture for Head and Neck Cancer (HNC) patients with dysphagia after chemoradiation therapy (CRT). The following hypotheses will be evaluated:

Aim 1. HNC patients will be willing and eligible to participate in a clinical trial of acupuncture, and be adherent to protocol acupuncture and baseline and follow-up outcomes testing.

Aim 2. At 20 weeks post CRT and 6 months following the acupuncture treatment: a) the MDADI total score and its sub-scores will be higher in active acupuncture vs. sham control; b) the time-to-removal of the feeding tube will be shorter in the active acupuncture vs. sham control; c) body weight recovery will increase faster in active acupuncture vs. sham control.

Aim 3. At 20 weeks post CRT, the plasma Transforming Growth Factor (TGF)-β1 level measured in patients treated with acupuncture will demonstrate trends of a decreased level when compared with a group of similar patients treated with sham acupuncture.


Condition Intervention
Carcinomas, Squamous Cell Dysphagia Device: Acupuncture

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Weidong Lu, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Recruitment Rate [ Time Frame: Assessed during the entire enrollment period which at study completion was determined to be approximately 3 years ]
    Recruitment rate is the proportion of screened patients who were eligible and agreed to participate.

  • Feasibility Rate [ Time Frame: Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks) ]
    Feasibility rate is the proportion of enrolled patients who completed at least 80% of treatment (10 acupuncture sessions).


Secondary Outcome Measures:
  • MDADI change from baseline to 12 months post chemoradiation therapy (CRT) [ Time Frame: Assessed at baseline and long-term at 6 mos post-treatment which parallels 12 mos post-CRT ]
    The M.D. Anderson Dysphagia Inventory (MDADI) score 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 change from baseline to wk 2 during acupuncture treatment [ Time Frame: Assessed at baseline and wk 2 during acupuncture treatment ]
    The M.D. Anderson Dysphagia Inventory (MDADI) score 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 change from baseline to wk 4 during acupuncture treatment [ Time Frame: Assessed at baseline and wk 4 during acupuncture treatment ]
    The M.D. Anderson Dysphagia Inventory (MDADI) score 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 change from baseline to wk 8 during acupuncture treatment [ Time Frame: Assessed at baseline and wk 8 during acupuncture treatment ]
    The M.D. Anderson Dysphagia Inventory (MDADI) score 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 change from baseline to wk 12 during acupuncture treatment [ Time Frame: Assessed at baseline and wk 12 during acupuncture treatment ]
    The M.D. Anderson Dysphagia Inventory (MDADI) score 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 change from baseline to wk 20 during acupuncture treatment [ Time Frame: Assessed at baseline and wk 20 during acupuncture treatment ]
    The M.D. Anderson Dysphagia Inventory (MDADI) score 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)


Other Outcome Measures:
  • change in plasma Transforming Growth Factor (TGF)-β1 from baseline to wk 20 during acupuncture treatment [ Time Frame: Assessed at baseline and wk 20 during acupuncture treatment ]
    Plasma Transforming Growth Factor (TGF)-β1 levels will be estimated based on established methods.


Enrollment: 42
Study Start Date: December 2008
Study Completion Date: August 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Acupuncture
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
Device: Acupuncture
Sham Comparator: Sham Acupuncture
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
Device: Acupuncture

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. 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.

  Eligibility

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;
  Contacts and Locations
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
  More Information

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 Submitted: November 21, 2008
First Posted: November 25, 2008
Last Update Posted: November 1, 2017
Last Verified: June 2017
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