Acupuncture in Treating Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer
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ClinicalTrials.gov Identifier: NCT01141231 |
Recruitment Status
:
Active, not recruiting
First Posted
: June 10, 2010
Last Update Posted
: February 14, 2018
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RATIONALE: Acupuncture may help relieve dry mouth caused by radiation therapy.
PURPOSE: This randomized phase III trial is studying to see how well one set of acupuncture points work in comparison to a different set of acupuncture points or standard therapy in treating dry mouth caused by radiation therapy in patients with head and neck cancer.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer Long-term Effects Secondary to Cancer Therapy in Adults Oral Complications of Chemotherapy and Head/Neck Radiation Radiation Toxicity Xerostomia | Procedure: Acupuncture | Phase 3 |
OBJECTIVES:
Primary
- To determine whether acupuncture can symptomatically improve moderate or severe radiation-induced xerostomia (grade 2 or 3) in patients with head and neck cancer.
Secondary
- To explore the duration of response (up to a maximum of 6 months) in the subgroup of patients who report a response to the acupuncture intervention.
OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease, age, sex, the mean of parotid radiotherapy doses received, and baseline Xerostomia Questionnaire (XQ) scores. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive standard oral hygiene care for 8 weeks, including instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice.
- Arm II: Patients receive acupuncture at 3 sites on each ear, on the chin, on each forearm, and on each leg twice a week for 4 weeks. Patients with minor response may continue treatment for an additional 4 weeks. Patients also receive standard oral hygiene as in arm 1.
- Arm III: Patients receive acupuncture twice a week for 4 weeks and standard oral hygiene as in arm 1. Patients with minor response may continue treatment for an additional 4 weeks.
Patients complete XQ, the M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), and the Functional Assessment of Cancer Therapy (FACT-G) questionnaires at baseline and at the end of weeks 4, 8, and12. Patients with partial response or minor response, according to week-8 questionnaires, complete XQ, MDASI-HN, and the FACT-G at the end of week 12 and at 6 months. Patients in group 2 and 3 also complete the Acupuncture Expectancy Scale (AES). Saliva is also collected at these time points.
- Coordinating Center: The University of Texas MD Anderson Cancer Center Community Clinical Oncology Program (CCOP) Research Base
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer |
Actual Study Start Date : | November 2012 |
Estimated Primary Completion Date : | November 2019 |
Estimated Study Completion Date : | November 2020 |

Arm | Intervention/treatment |
---|---|
No Intervention: Standard Care
Standard oral hygiene care for 8 weeks, including instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice.
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Active Comparator: Acupuncture Group 1
Acupuncture at 3 sites on each ear, on the chin, on each forearm, and on each leg twice a week for 4 weeks; and standard oral hygiene as in standard of care arm.
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Procedure: Acupuncture
Patients undergo acupuncture twice weekly for 4 weeks
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Active Comparator: Acupuncture Group 2
Acupuncture twice a week for 4 weeks and standard oral hygiene as in standard of care arm.
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Procedure: Acupuncture
Patients undergo acupuncture twice weekly for 4 weeks
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- Response to acupuncture intervention [ Time Frame: Baseline to 4 weeks post acupuncture ]Xerostomia Questionnaire score before and 4 weeks after starting acupuncture. The Xerostomia Questionnaire is an 8-item survey with each item scored between 0 and 10 then the final score normalized to a 0-100 scale. High score of 10 = increased severity of xerostomia.
- Duration of response to a maximum of 6 months [ Time Frame: Baseline to 6 Months ]Duration of response assessed by determining Xerostomia Questionnaire scores at 8 and 12 weeks and the 6 month follow-up.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must be at least 18 years of age and able to give informed consent.
- Must have a diagnosis of head/neck cancer.
- Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to RTOG scale: Grade 0 - None Grade 1 - Slight dryness of mouth, good response on stimulation Grade 2 - Moderate dryness of mouth, poor response on stimulation Grade 3 - Complete dryness of mouth, no response on stimulation Grade 4 - Fibrosis
- Must have received external beam radiation at a mean dose of at least 25 Gy to one of the parotid glands. The other gland can receive less than 25 Gy. (Chemotherapy during or subsequent to radiation therapy is allowed).
- Must have completed radiotherapy at least 12 months prior to entry. Note: Patients currently receiving radiation therapy not involving radiation to the head and neck may be eligible to participate in this trial.
- Must have anatomically intact parotid and submandibular glands.
- Must be acupuncture naïve.
- Must not have any history of xerostomia prior to radiation therapy.
- No active infection.
- Must have Karnofsky performance status >/= 60 or ECOG performance status of 0-2.
Exclusion Criteria:
- History of xerostomia, Sjogren's disease or other illness known to affect salivation prior to head/neck radiation.
- Suspected or confirmed closure of salivary gland ducts on either side.
- Currently receiving or planning to use receive other xerostomia treatment, including drugs, herbs, alternative medicines, or devices that could affect salivary production. All other tTreatments known to affect salivation should be stopped at least 14 days prior to enrollment. Over the counter products used for salivary substitution are allowed, but will need to be discontinued for at least 24 hours prior to saliva and questionnaire data collection.
- Have received any investigational new drug within the past 30 days or planning to receive such during the study period.
- Previous acupuncture treatment.
- Active systemic infection or skin infection at or near the acupuncture sites.
- History of xerostomia prior to the head/neck radiation therapy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141231
United States, Texas | |
CCOP Research Base Sites | |
Houston, Texas, United States, 77030 |
Study Chair: | Lorenzo Cohen, PhD | M.D. Anderson Cancer Center | |
Study Chair: | Mark S. Chambers, DMD, MS | M.D. Anderson Cancer Center |
Additional Information:
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT01141231 History of Changes |
Other Study ID Numbers: |
2010-0547 MDA MDA-04-01 CDR0000674208 ( Other Identifier: NCI Clinical Trials ) 2010-0547 ( Other Identifier: MD Anderson Cancer Center ) NCI-2011-02073 ( Registry Identifier: NCI CTRP ) U10 ( Other Grant/Funding Number: CCOP Grant ) CA160880 ( Other Grant/Funding Number: NCI ) |
First Posted: | June 10, 2010 Key Record Dates |
Last Update Posted: | February 14, 2018 |
Last Verified: | February 2018 |
Keywords provided by M.D. Anderson Cancer Center:
hypopharyngeal cancer laryngeal cancer lip and oral cavity cancer nasopharyngeal cancer oropharyngeal cancer paranasal sinus and nasal cavity cancer |
salivary gland cancer radiation toxicity xerostomia long-term effects of cancer treatment oral complications of radiation therapy |
Additional relevant MeSH terms:
Head and Neck Neoplasms Xerostomia Radiation Injuries Neoplasms by Site Neoplasms |
Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Wounds and Injuries |