Acupuncture in Treating Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Detailed Description:

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 Design

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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

Arms and Interventions

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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.
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.	Procedure: Acupuncture; Patients undergo acupuncture twice weekly for 4 weeks
Active Comparator: Acupuncture Group 2; Acupuncture twice a week for 4 weeks and standard oral hygiene as in standard of care arm.	Procedure: Acupuncture; Patients undergo acupuncture twice weekly for 4 weeks

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Must be at least 18 years of age and able to give informed consent.
2. Must have a diagnosis of head/neck cancer.
3. 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
4. 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).
5. 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.
6. Must have anatomically intact parotid and submandibular glands.
7. Must be acupuncture naïve.
8. Must not have any history of xerostomia prior to radiation therapy.
9. No active infection.
10. Must have Karnofsky performance status >/= 60 or ECOG performance status of 0-2.

Exclusion Criteria:

1. History of xerostomia, Sjogren's disease or other illness known to affect salivation prior to head/neck radiation.
2. Suspected or confirmed closure of salivary gland ducts on either side.
3. 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.
4. Have received any investigational new drug within the past 30 days or planning to receive such during the study period.
5. Previous acupuncture treatment.
6. Active systemic infection or skin infection at or near the acupuncture sites.
7. History of xerostomia prior to the head/neck radiation therapy.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Texas
CCOP Research Base Sites
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Lorenzo Cohen, PhD	M.D. Anderson Cancer Center
Study Chair:	Mark S. Chambers, DMD, MS	M.D. Anderson Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

University of Texas MD Anderson Cancer Center Official Website 

MD Anderson Cancer Center CCOP Research Base Official Website 

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
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