Clinical trial · Interventional

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

NCT00797732CI-TRIAL-00031646completedN/AResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Carcinomas, Squamous Cell	Squamous Cell Carcinoma	ONTOLOGY_EXACT	0.98
Dysphagia	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Acupuncture	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Active Acupuncture
description
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. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; MacPherson H, Altman DG et al. PLoS Med 2010;7:e1000261\]
interventionNames
1. Device: Acupuncture
type
SHAM_COMPARATOR
label
Sham Acupuncture
description
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. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005;86:2248-2255\]

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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;

References

Publications (4)

BACKGROUNDLu W, Wayne PM, Davis RB, Buring JE, Li H, Goguen LA, Rosenthal DS, Tishler RB, Posner MR, Haddad RI. Acupuncture for dysphagia after chemoradiation in head and neck cancer: rationale and design of a randomized, sham-controlled trial. Contemp Clin Trials. 2012 Jul;33(4):700-11. doi: 10.1016/j.cct.2012.02.017. Epub 2012 Mar 2. PMID 22406102
BACKGROUNDLu W, Posner MR, Wayne P, Rosenthal DS, Haddad RI. Acupuncture for dysphagia after chemoradiation therapy in head and neck cancer: a case series report. Integr Cancer Ther. 2010 Sep;9(3):284-90. doi: 10.1177/1534735410378856. Epub 2010 Aug 16. PMID 20713374
BACKGROUNDLu W, Wayne PM, Davis RB, Buring JE, Li H, Macklin EA, Lorch JH, Burke E, Haddad TC, Goguen LA, Rosenthal DS, Tishler RB, Posner MR, Haddad RI. Acupuncture for Chemoradiation Therapy-Related Dysphagia in Head and Neck Cancer: A Pilot Randomized Sham-Controlled Trial. Oncologist. 2016 Dec;21(12):1522-1529. doi: 10.1634/theoncologist.2015-0538. Epub 2016 Aug 10. PMID 27511906
DERIVEDLu W, Giobbie-Hurder A, Tanasijevic A, Baedorf Kassis S, Park SH, Jeong YJ, Shin IH, Yao C, Jung HJ, Zhu Z, Bao C, Yang EM, Bierer BE, Ligibel JA. Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol. Contemp Clin Trials. 2022 Oct;121:106885. doi: 10.1016/j.cct.2022.106885. Epub 2022 Aug 20. PMID 35998768

Registry

Dates and enrollment

Start: Dec 1, 2008
Primary completion: Jan 1, 2013
Completion: Aug 1, 2015
First posted: Nov 25, 2008
Last update posted: Feb 13, 2018
Results first posted: Feb 13, 2018
Enrollment: 42 (actual)
Lead sponsor: Dana-Farber Cancer Institute OTHER
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Keywords: acupuncture, dysphagia, chemoradiation related effects, squamous cell carcinoma of the head and neck, nasopharyngeal cancer, oropharynx cancer, hypopharynx cancer, larynx cancer

Data updated 22 days agoSource updated Feb 13, 2018source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.