A Pilot Study of Acupuncture Treatment for Dysphagia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weidong Lu, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00797732
First received: November 21, 2008
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

This study is a pilot randomized, sham-controlled trial of acupuncture for Head and Neck Cancer patients with dysphagia after chemoradiation therapy. The study will assess the feasibility of recruiting and retaining head and neck cancer patients, will assess the feasibility of administering the acupuncture protocol as well as a series of outcome instruments and protocols, and will collect preliminary data on the efficacy and safety of acupuncture on dysphagia related symptoms and health related quality of life.


Condition Intervention
Carcinomas, Squamous Cell
Dysphagia
Device: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • MDADI will be measured at baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks post CRT and 6 months follow up (12 mo from baseline). [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks post CRT, and 6 months followup ( 12 mo from baseline) ] [ Designated as safety issue: Yes ]
    M.D. Anderson Dysphagia Inventory (MDADI) is used for the primary outcome measure.


Secondary Outcome Measures:
  • Other QOL, salivary flow rates and cytokines measures [ Time Frame: baseline, last session of acupuncture ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: December 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Acupuncture
Study patients will receive 12 sessions of active acupuncture.
Device: Acupuncture
active acupuncture (n=21) or sham acupuncture (n=21), once every 2 weeks for 24 weeks.
Sham Comparator: Sham Acupuncture
Study patients will receive 12 sessions of sham acupuncture
Device: Acupuncture
active acupuncture (n=21) or sham acupuncture (n=21), once every 2 weeks for 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797732

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Weidong Lu, MB, MPH, PhD Harvard Medical School/Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Weidong Lu, Instructor in Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00797732     History of Changes
Other Study ID Numbers: K01 AT004415-01, K01AT004415-01, DFCI-08169
Study First Received: November 21, 2008
Last Updated: February 10, 2014
Health Authority: United States: Federal Government

Keywords provided by 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:
Carcinoma
Carcinoma, Squamous Cell
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on October 22, 2014