Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer

Study Overview
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Brief Summary
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This study is being done to find out what effects, good and/or bad, acupuncture has on participants and their xerostomia caused by radiation therapy for the treatment of the cancer.

Detailed Description
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Patients who have met all eligibility criteria will be randomized to standard oral hygiene, standard oral hygiene + true acupuncture twice weekly for 4 weeks, or standard oral hygiene + sham acupuncture twice weekly for 4 weeks by a form of adaptive randomization, called minimization, because simple randomization could result in covariate imbalances . The acupuncture points will be at three sites on each ear (Shenmen, Point Zero, Salivary Gland 2-prime), a site on the chin (CV24), a site on each forearm (Lu7), a site on each hand (LI 1-prime), a site on each leg (K6), and one placebo needle at Gb32 for a total of 14 sites. All sites will be applied for 20 minutes. For body points, standardized techniques for location will be utilized, which are based on anatomical landmarks as well as proportional measurements using the patient's own body. For example, finger breadth is based on each patient's middle finger, and the proportional unit of measure, the cun, is defined as the distance between the two medial ends of the creases of the interphalangeal joints when the middle finger is flexed. Earpoint locations will mimic standard practice and be identified by the acupuncturists.

Official Title
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A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer

Conditions
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Radiation-Induced Xerostomia, Head and Neck Cancer, Radiation Toxicity, Oral Complications of Chemotherapy and Head/Neck Radiation

Intervention / Treatment
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* Other: Standard Oral Hygiene
* Other: Standard Oral Hygiene + True Acupuncture
* Other: Standard Oral Hygiene + Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be at least 18 years of age and able to give informed consent. Must be able to read, write and understand English. Must have a diagnosis of head/neck cancer. Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified RTOG scale: Grade 0 - None Grade 1 - Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary) Grade 2 - Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods) Grade 3 - Complete dryness of mouth (no response on stimulation and difficult oral alimentation; IV fluids, pureed diet or tube feedings may be required) Grade 4 - Fibrosis Must have received external beam radiation at a mean dose of at least 24 Gy to one of the parotid glands. The other gland can receive less than 24 Gy. Must have completed radiotherapy at least 12 months prior to entry. Must have anatomically intact parotid and submandibular glands. A focused (head/neck) history and exam conducted by a physician or dentist within the past year is required. Must be acupuncture naïve. Must have 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 known closure of salivary gland ducts on either side. (Patients addressed in inclusion criteria (i.e. those who have had one submandibular gland removed) are expected to have closure to the removed submandibular gland and will be exempt from this exclusion criteria.) Currently receiving or planning to use drugs, herbs, alternative medicines, or devices that could affect salivary production. Treatment 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. Active systemic infection or skin infection at or near the acupuncture sites. Receiving chemotherapy during study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Oral Hygiene<br>All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. | Other: Standard Oral Hygiene<br>* Oral hygiene care provided per individual institutions standard of care.<br>* Other names: Oral Hygiene;|
| Experimental: Standard Oral Hygiene + True Acupuncture<br>All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes. | Other: Standard Oral Hygiene + True Acupuncture<br>* Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.<br>|
| Other: Standard Oral Hygiene + Sham Acupuncture<br>All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points. | Other: Standard Oral Hygiene + Sham Acupuncture<br>* Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.<br>* Other names: Placebo acupuncture needle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9 Item Xerostomia Questionnaire | Self reported Xerostomia questionnaire completed prior to study randomization. Each item is scored on a scale of 0-10 with higher scores indicating greater dryness or discomfort due to dryness, yielding a total between 0 and 90. | Baseline to 4 weeks post acupuncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response to a maximum of 6 months | Duration of response assessed by determining Xerostomia Questionnaire scores at 8 and 12 weeks and the 6 month follow-up. | Baseline to 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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