Overview

This trial has been completed.

Conditions carcinomas, squamous cell, dysphagia
Treatment acupuncture
Sponsor Dana-Farber Cancer Institute
Collaborator National Center for Complementary and Integrative Health (NCCIH)
Start date December 2008
End date January 2013
Trial size 42 participants
Trial identifier NCT00797732, DFCI-08169, K01AT004415-01

Summary

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose supportive care
Masking participant, outcomes assessor
Arm
(Active Comparator)
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.
acupuncture
(Sham Comparator)
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.
acupuncture

Primary Outcomes

Measure
Recruitment Rate
time frame: Assessed during the entire enrollment period which at study completion was determined to be approximately 3 years.
Feasibility Rate
time frame: Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks).
MDADI change from baseline to 12 months post chemoradiation therapy (CRT)
time frame: Assessed at baseline, 2-, 4-, 8-, 12- and 20-wks during acupuncture treatment and long-term at 6 mos post-treatment which parallels 12 mos post-CRT

Eligibility Criteria

All 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.