Overview

This trial is active, not recruiting.

Conditions carcinomas, squamous cell, dysphagia
Treatment acupuncture
Sponsor Dana-Farber Cancer Institute
Collaborator National Center for Complementary and Alternative Medicine (NCCAM)
Start date December 2008
End date February 2014
Trial size 42 participants
Trial identifier NCT00797732, DFCI-08169, K01 AT004415-01, K01AT004415-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose supportive care
Arm
(Active Comparator)
Study patients will receive 12 sessions of active acupuncture.
acupuncture
active acupuncture (n=21) or sham acupuncture (n=21), once every 2 weeks for 24 weeks.
(Sham Comparator)
Study patients will receive 12 sessions of sham acupuncture
acupuncture
active acupuncture (n=21) or sham acupuncture (n=21), once every 2 weeks for 24 weeks.

Primary Outcomes

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

Secondary Outcomes

Measure
Other QOL, salivary flow rates and cytokines measures
time frame: baseline, last session of acupuncture

Eligibility Criteria

Male or female participants at least 18 years old.

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;

Additional Information

Official title Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial
Principal investigator Weidong Lu, MB, MPH, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.