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Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial


N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinomas, Squamous Cell, Dysphagia

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Trial Information

Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial


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;

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

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).

Outcome Description:

M.D. Anderson Dysphagia Inventory (MDADI) is used for the primary outcome measure.

Outcome Time Frame:

baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks post CRT, and 6 months followup ( 12 mo from baseline)

Safety Issue:

Yes

Principal Investigator

Weidong Lu, MB, MPH, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Harvard Medical School/Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

K01 AT004415-01

NCT ID:

NCT00797732

Start Date:

December 2008

Completion Date:

March 2013

Related Keywords:

  • Carcinomas, Squamous Cell
  • Dysphagia
  • acupuncture
  • dysphagia
  • chemoradiation related effects
  • squamous cell carcinoma of the head and neck
  • nasopharyngeal cancer
  • oropharynx cancer
  • hypopharynx cancer
  • larynx cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Deglutition Disorders
  • Head and Neck Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115