| ID | Type | Description | Link |
|---|---|---|---|
| REBAWF 97115 | Other Identifier | NCI | |
| NCI-2011-02073 | Registry Identifier | NCI CTRP |
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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.
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. Ear point locations will mimic standard practice and be identified by the acupuncturists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Oral Hygiene | Active Comparator | 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. |
|
| Standard Oral Hygiene + True Acupuncture | Experimental | 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. |
|
| Standard Oral Hygiene + Sham Acupuncture | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Oral Hygiene | Other | Oral hygiene care provided per individual institutions standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Xerostomia Questionnaire Scores | Self reported Xerostomia questionnaire consists of eight items (scored on an 11-point scale; 0-10), has been validated in several cohorts, and is regarded as the gold-standard measure for xerostomia.The questions are equally divided into 4 items about oral dryness while eating or chewing and 4 items about dryness while not eating or chewing. Item scores are summed and transformed linearly to produce a final summary score between 0 and 80. Higher scores represent more xerostomia. Questionnaire is completed prior to randomization and at each time point week 4, week 8, week 12, and end of study. | Baseline to 4, 8, 12, 26 weeks post acupuncture |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy (FACT-G) Total | The FACT-G QOL instrument discriminates between individuals with metastatic and non-metastatic disease, as well as between patients at different stages of illness. The scale has good concurrent validity, high internal consistency (0.89), and good test-re-test reliability (0.82 to 0.88). The total score is reported, which is a combination of the subscales of physical, social/family, emotional, and functional well-being, with higher scores representing better QOL. Scale range 0-108 |
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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 Radiation Therapy Oncology Group (RTOG) scale:
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 Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne C Danhauer, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38739392 | Derived | Cohen L, Danhauer SC, Garcia MK, Dressler EV, Rosenthal DI, Chambers MS, Cusimano A, Brown WM, Ochoa JM, Yang P, Chiang JS, Gordon O, Crutcher R, Kim JK, Russin MP, Lukenbill J, Porosnicu M, Yost KJ, Weaver KE, Lesser GJ. Acupuncture for Chronic Radiation-Induced Xerostomia in Head and Neck Cancer: A Multicenter Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410421. doi: 10.1001/jamanetworkopen.2024.10421. |
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Wake Forest (WF) National Cancer Institute Community Oncology Research Program (NCORP) Research Base (RB) is committed to following the NIH Statement on Sharing Research Data. 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. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the National Clinical Trials Network (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.
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6 months after publication for a 2 year duration
upon request
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258 of 281 eligible screened participants enrolled and randomized into study. Reasons for the 23 which chose not to participate: 16 no reason given 5 Too busy
1 did not want randomization
1 distance.
Study was designed with first enrollment July 29,2013 under the oversight of MD Anderson (MDA) Community Clinical Oncology Program (CCOP) Research Base (RB) (NCI Division of Cancer Prevention (DCP) #MDA 04-01; MDA Protocol #2010-0547). Twenty-eight participants recruited from multiple centers. After the MDA CCOP RB was closed, the trial transferred to Wake Forest (WF) NCI Community Oncology Research Program (NCORP) RB (2UG1CA189824) where the trial continued (WF-97115) from April 2016-June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Standard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 26, 2019 |
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| Standard Oral Hygiene + True Acupuncture | Other | 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. |
|
| Standard Oral Hygiene + Sham Acupuncture | Other | 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. |
|
|
| Baseline, 4 , 8 , 12, and 26 weeks |
| The Acupuncture Expectancy Scale (AES) | The 4-item AES was used to ensure there were no baseline group differences in expectations related to the benefits of acupuncture on dry mouth and to assess aspects of blinding after the first 4 weeks of acupuncture for the TA and SA groups. The AES is reliable (α=0·82) and valid by positive correlation with patient self-reported efficacy and satisfaction. The scale has been further validated among cancer patients who were acupuncture naïve. Scale from 4-20. | Week 4 |
| Kaiser Permanente-San Francisco |
| San Francisco |
| California |
| 94115 |
| United States |
| Kaiser Permanente-Santa Teresa-San Jose | San Jose | California | 95119 | United States |
| Kaiser Permanente-San Rafael | San Rafael | California | 94903 | United States |
| Kaiser San Rafael-Gallinas | San Rafael | California | 94903 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente-Santa Rosa | Santa Rosa | California | 95403 | United States |
| Kaiser Permanente-South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente-Walnut Creek | Walnut Creek | California | 94596 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | 96817 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Physicians' Clinic of Iowa PC | Cedar Rapids | Iowa | 52402 | United States |
| Saint Luke's Hospital | Cedar Rapids | Iowa | 52402 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | United States |
| Christus Saint Vincent Regional Cancer Center | Santa Fe | New Mexico | 87505 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Columbus Oncology and Hematology Associates Inc | Columbus | Ohio | 43214 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | 29316 | United States |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | United States |
| Meharry Medical College | Nashville | Tennessee | 37208 | United States |
| MD Anderson in The Woodlands | Conroe | Texas | 77384 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| MD Anderson West Houston | Houston | Texas | 77079 | United States |
| Providence Regional Cancer System-Lacey | Lacey | Washington | 98503 | United States |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Standard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care. |
| BG001 | 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. 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. |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Insurance - Medicare | Count of Participants | Participants |
| |||||||||||
| Insurance - Medicaid | Count of Participants | Participants |
| |||||||||||
| Insurance - Private | Count of Participants | Participants |
| |||||||||||
| Insurance - None | Count of Participants | Participants |
| |||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| ||||||||||
| Education | Count of Participants | Participants |
| |||||||||||
| Job Status | Count of Participants | Participants |
| |||||||||||
| Baseline values for outcomes | Self reported Xerostomia questionnaire consists of 8 items (scored on 11-point scale; 0-10). Item scores are summed and transformed linearly for final score between 0 and 80. Higher scores indicate worse xerostomia symptoms. The Functional Assessment of Cancer Therapy (FACT-G) Total (27 questions scored on 5-point scale; 0-4) summary score 0-108. Higher scores indicate better quality of life. Acupuncture Expectancy Scale (AES) is 4-item questionnaire (scored on a 5-point scale; 1-5) summary score between 4 and 20. Higher scores indicating greater expectancy. | Some outcome values are missing for participants at baseline | Mean | Standard Deviation | scoring on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Xerostomia Questionnaire Scores | Self reported Xerostomia questionnaire consists of eight items (scored on an 11-point scale; 0-10), has been validated in several cohorts, and is regarded as the gold-standard measure for xerostomia.The questions are equally divided into 4 items about oral dryness while eating or chewing and 4 items about dryness while not eating or chewing. Item scores are summed and transformed linearly to produce a final summary score between 0 and 80. Higher scores represent more xerostomia. Questionnaire is completed prior to randomization and at each time point week 4, week 8, week 12, and end of study. | Intent to treat analysis. Considered and utilized all data available at each timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale 0-80 | Baseline to 4, 8, 12, 26 weeks post acupuncture |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Therapy (FACT-G) Total | The FACT-G QOL instrument discriminates between individuals with metastatic and non-metastatic disease, as well as between patients at different stages of illness. The scale has good concurrent validity, high internal consistency (0.89), and good test-re-test reliability (0.82 to 0.88). The total score is reported, which is a combination of the subscales of physical, social/family, emotional, and functional well-being, with higher scores representing better QOL. Scale range 0-108 | Intent to treat analysis. Considered and utilized all data available at each timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale 0-108 | Baseline, 4 , 8 , 12, and 26 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Acupuncture Expectancy Scale (AES) | The 4-item AES was used to ensure there were no baseline group differences in expectations related to the benefits of acupuncture on dry mouth and to assess aspects of blinding after the first 4 weeks of acupuncture for the TA and SA groups. The AES is reliable (α=0·82) and valid by positive correlation with patient self-reported efficacy and satisfaction. The scale has been further validated among cancer patients who were acupuncture naïve. Scale from 4-20. | Intent to treat analysis excluding standard oral hygiene group. Considered and utilized all data available at each timepoint. AES was not collected for the standard oral hygiene arm per protocol specifications. Standard oral hygiene participants were not to receive any form of acupuncture making this outcome not applicable for these participants and therefore not collected. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale 4-20 | Week 4 |
|
Collected at weeks 4, 8, 12 and 24. July 29,2013 under the oversight of the MD Anderson Community Clinical Oncology Program Research Base (MDA CCOP RB) (NCI DCP #MDA 04-01; MD Anderson Protocol #2010-0547). (WF-97115) from April 2016 through June 2021.
By protocol definitions, only grade 1-3 adverse events that were deemed definitely, possibly, or probably related to treatment and all grade 3-5 severe adverse events (SAEs) were to be reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Standard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care. | 1 | 86 | 0 | 86 | 0 | 86 |
| EG001 | 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. 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. | 0 | 86 | 0 | 86 | 3 | 86 |
| EG002 | 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. 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. | 1 | 86 | 0 | 86 | 3 | 86 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema face | General disorders | CTCAE v5.0 | Non-systematic Assessment |
| |
| Flu like systoms | General disorders | CTCAE v5.0 | Non-systematic Assessment |
| |
| Joint Pain | Musculoskeletal and connective tissue disorders | CTCAE v.50 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v5.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE v5.0 | Non-systematic Assessment |
|
The trial was not successful at recruiting a large sample of ethnically/racially underserved participants. In addition, the majority of the patients were also men, but participation of women reflected the incidence of head and neck (HN) cancer in men and women. Most of the patients only received 4 weeks of acupuncture and no maintenance treatments were provided. Future research should examine if the effects can be enhanced with further treatments.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lead Biostatistician (Dr. Emily Dressler) | Wake Forest NCORP Research Base | 336-716-0891 | NCORP@wakehealth.edu |
| Aug 1, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2017 | Nov 1, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D011832 | Radiation Injuries |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D012468 | Salivary Gland Neoplasms |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014947 | Wounds and Injuries |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D009059 | Mouth Diseases |
| D009302 | Nasopharyngeal Diseases |
| D012466 | Salivary Gland Diseases |
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| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| ID | Term |
|---|---|
| D006920 | Hygiene |
| D013812 | Therapeutics |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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| FACT-G Total Score (scale 0-108) |
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| Acupuncture Expectancy Scale (AES) Score (scale 4-20) |
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| Week 12 |
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| Week 26 |
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| OG002 | 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. 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. |
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| OG001 | 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. 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. |
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