Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer (ACUPUNCTURE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02589938 |
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Recruitment Status :
Completed
First Posted : October 28, 2015
Last Update Posted : November 4, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Radiation-Induced Xerostomia Head and Neck Cancer Radiation Toxicity Oral Complications of Chemotherapy and Head/Neck Radiation | Other: Standard Oral Hygiene Other: Standard Oral Hygiene + True Acupuncture Other: Standard Oral Hygiene + Sham Acupuncture | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 230 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| 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 11, 2012 |
| Actual Primary Completion Date : | July 29, 2022 |
| Actual Study Completion Date : | July 29, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard Oral Hygiene
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.
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Other: Standard Oral Hygiene
Oral hygiene care provided per individual institutions standard of care.
Other Name: Oral Hygiene |
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Experimental: Standard Oral Hygiene + True Acupuncture
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
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. |
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Standard Oral Hygiene + Sham Acupuncture
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
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.
Other Name: Placebo acupuncture needle |
- 9 Item Xerostomia Questionnaire [ Time Frame: Baseline to 4 weeks post acupuncture ]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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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 be able to read, write and understand English.
- Must have a diagnosis of head/neck cancer.
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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.
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): NCT02589938
Show 36 study locations
| Principal Investigator: | Suzanne C Danhauer, PhD | Wake Forest University Health Sciences |
Documents provided by Wake Forest University Health Sciences:
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT02589938 |
| Obsolete Identifiers: | NCT01141231 |
| Other Study ID Numbers: |
IRB00038707 REBAWF 97115 ( Other Identifier: NCI ) NCI-2011-02073 ( Registry Identifier: NCI CTRP ) |
| First Posted: | October 28, 2015 Key Record Dates |
| Last Update Posted: | November 4, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514. |
| Time Frame: | 6 months after publication for a 2 year duration |
| Access Criteria: | upon request to NCORP@wakehealth.edu |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Head and Neck Neoplasms Xerostomia Neoplasms by Site Neoplasms |
Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases |