A Pilot Study of Acupuncture Treatment for Dysphagia

Dana-Farber Cancer Institute42 enrolled

Overview

The current standard of care for advanced HNC is concurrent chemoradiation therapy (CRT), which has led to increased survival rates, but with significant acute and long-term toxicities. Dysphagia, or difficulty with swallowing, is a common and expected side effect during and following CRT. Dysphagia occurs in up to 50% of patients and significantly impairs the quality of life (QOL) of patients during delivery of and recovery from CRT. Clinical trials evaluating promising and innovative adjunctive approaches that could increase the rate and magnitude of recovery from dysphagia in HNC patients are needed. Acupuncture is a traditional Chinese medical technique that has been found to reduce symptoms and side effects associated with primary cancer therapy. This study evaluated the feasibility of conducting a randomized sham-controlled trial and collected preliminary data on safety and efficacy of acupuncture.

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. (Exploratory) 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Outcome Compliance Rate

Outcome compliance rate is the percentage of enrolled participants who completed the primary study assessments (at baseline and in long-term follow-up 6 months post acupuncture treatment).

Time frame: Assessed at baseline and at 6 months post acupuncture treatment

Treatment Compliance Rate

Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).

Time frame: Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks)

Secondary Outcomes

MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)

The M.D. Anderson Dysphagia Inventory (MDADI) 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 has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline.

Time frame: Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT

MDADI Scores

Time frame: Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture