Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Deglutition Disorders

Laryngeal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Neoplasms, Squamous Cell

Hypopharyngeal Cancer

The active intervention used a three-phase step-up protocol to gradually increase the body areas treated and needling intensity. Acupuncture needles (0.20x25mm) were inserted with a depth of 5-10 mm into predefined points based on a systematic literature review following the STRICTA guideline. Needles were stimulated to obtain the de qi sensation. An electroacupuncture (EA) device was connected at two acupoints. All needles remained in place for 30 minutes. The active acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; MacPherson H, Altman DG et al. PLoS Med 2010;7:e1000261\]

The sham intervention was designed to be maximally inert and minimally invasive, while simulating most aspects of the active protocol. Sham needles (0.12x30mm) were inserted at 14 locations paralleling the same body regions needled in the active group; however, all sham point locations were off the pathways of traditional Chinese medicine acupuncture meridians and points. An identical but deactivated EA device was used following sham protocols previously used. The sham acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005;86:2248-2255\]

Acupuncture

Weidong Lu, MB, MPH, PhD

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.

A Pilot Study of Acupuncture Treatment for Dysphagia

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

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).

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

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.

National Center for Complementary and Integrative Health (NCCIH)

Dana-Farber Cancer Institute

Principal Investigator

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.

Active Acupuncture

Sham Acupuncture

TBoth 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.

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

IMRT, intensity modulated radiation therapy, dose received

Total IMRT dose (Gy)

The analysis population is comprised of all randomized participants.

Weidong Lu, PhD, MB, Lic.Ac.

Outcome Compliance Rate

Treatment Compliance Rate

The analysis population represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture

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

Baseline

20 weeks post chemoradiation start

6 months post acupuncture start

The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.

MDADI Scores

The sham intervention was designed to be maximally inert and minimally invasive, while simulating most aspects of the active protocol. Sham needles (0.12x30mm) were inserted at 14 locations paralleling the same body regions needled in the active group; however, all sham point locations were off the pathways of traditional Chinese medicine acupuncture meridians and points. An identical but deactivated EA device was used following sham protocols previously used. The sham acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005; 86:2248-2255\]

Participants approached in the screening process but ultimately not randomized.

Spots Global Cancer Trial Database for carcinomas, squamous cell