Carcinomas, Squamous CellNCT00797732

A Pilot Study of Acupuncture Treatment for Dysphagia

A study testing Acupuncture in people with Carcinomas, Squamous Cell and Dysphagia, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinomas, Squamous Cell, Dysphagia
What is being tested?: Acupuncture
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Dec 2008to Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

United States1 site

Dana-Farber Cancer Institute
Boston, Massachusetts, 02115

Other trials in United States

About this study

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

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.

Read the detailed 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. (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.

Conditions: Carcinomas, Squamous Cell, Dysphagia
Being tested: Acupuncture
Keywords: acupuncture, dysphagia, chemoradiation related effects, squamous cell carcinoma of the head and neck, nasopharyngeal cancer, oropharynx cancer, hypopharynx cancer, larynx cancer
Medical subject headings: Carcinoma, Squamous Cell, Deglutition Disorders, Squamous Cell Carcinoma of Head and Neck, Nasopharyngeal Neoplasms, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureDevice

Study groups in NCT00797732
Study group	Role	What they receive
Active Acupuncture	Active comparator	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] Receives: Device: Acupuncture
Sham Acupuncture	Sham comparator	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] Receives: Device: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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.
Measured: Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT
MDADI Scores
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.
Measured: Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Aug 2015

First posted25 Nov 2008 (estimated)
Study startDec 2008
Primary completionJan 2013
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Carcinomas, Squamous CellStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00797732
Sponsor's protocol ID: 08-169
Other IDs: K01AT004415-01, DFCI-08169
Status last verified: Jan 2018
First submitted: 21 Nov 2008
Last updated: 13 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Lu 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.
PubMed 22406102
Lu 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.
PubMed 20713374
Lu 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.
PubMed 27511906
Lu 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.
PubMed 35998768

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial
ClinicalTrials.gov ID: NCT00797732
Acronym / sponsor ID: 08-169
Conditions: Carcinomas, Squamous Cell, Dysphagia
Keywords: acupuncture, dysphagia, chemoradiation related effects, squamous cell carcinoma of the head and neck, nasopharyngeal cancer, oropharynx cancer, hypopharynx cancer, larynx cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Dec 2008
Primary completion: Jan 2013 (actual)
Study completion: Aug 2015 (actual)
First posted: 25 Nov 2008 (estimated)
Results: Posted 13 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed 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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active Acupuncture	Active comparator	Device: AcupunctureThe 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]
Sham Acupuncture	Sham comparator	Device: AcupunctureThe 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]

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acupuncture	Device	Active Acupuncture, Sham Acupuncture

Primary outcome

Outcome Compliance Rate
Time frame: Assessed at baseline and at 6 months post acupuncture treatment
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
Time frame: Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks)
Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).

2 secondary outcomes

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

Results and safety

Results posted to the registry on 13 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Acupuncture	21	16
Sham Acupuncture	21	18
Screened Non-Randomized	154	0

Primary outcome: Outcome Compliance Rate

Time frame: Assessed at baseline and at 6 months post acupuncture treatment. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Active Acupuncture n = 21	Sham Acupuncture n = 21
Value	76.2 (52.8 to 91.8)	85.7 (63.6 to 97.0)

Population analysed: The analysis population is comprised of all randomized participants.

Primary outcome: Treatment Compliance Rate

Time frame: Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Active Acupuncture n = 21	Sham Acupuncture n = 21
Value	76.2 (52.8 to 91.8)	81.0 (58.1 to 94.6)

Population analysed: The analysis population is comprised of all randomized participants.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were evaluated throughout treatment at each visit up to end of treatment week 20 after CRT.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Acupuncture	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21
Sham Acupuncture	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22406102Lu 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.
Background: PubMed 20713374Lu 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.
Background: PubMed 27511906Lu 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.
Derived from this study: PubMed 35998768Lu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Weidong Lu, MB, MPH, PhD principal investigator

Harvard Medical School/Dana-Farber Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Carcinomas, Squamous Cell and Dysphagia, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Outcome Compliance Rate (time frame: Assessed at baseline and at 6 months post acupuncture treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00797732, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.