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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00306 | Registry Identifier | NCI CTRP | |
| R01CA148707-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this clinical research study is to learn if acupuncture can help to prevent xerostomia (dry mouth) and improve the quality of life in patients who receive radiation treatment to the head and neck. This study will determine if one acupuncture treatment approach is more effective than another. Dry mouth is a common problem among cancer patients who have received radiation treatment to the head and neck.
Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) into 1 of 3 groups.
Group 1 will receive acupuncture during the radiation treatment period.
Group 2 will receive acupuncture at different points on the body than those in Group 1 during the radiation treatment period.
You will not know if you are assigned to Group 1 or 2.
Group 3 will receive standard care without any kind of acupuncture during the radiation treatment period.
Study Visits:
If you are in Group 1 and 2, you will receive up to 21 acupuncture treatments with no more than 3 treatments per week during your regularly scheduled radiotherapy visits. It will take about 20 minutes to complete the acupuncture session each time.
No matter which group you are assigned to, you will complete the following at the middle and end of radiotherapy treatment, and again 2-4, 5-9, 10-15 months after radiotherapy treatment is complete:
Length of Study:
You will remain on study for up to 17 months.
Additional Information:
After your participation on this study is complete and you are no longer enrolled in this study, if you were in Group 2 or 3, you will be offered to receive 3 acupuncture treatments.
This is an investigational study.
Up to 435 patients will take part in this multicenter study. Up to 193 will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture - Group 1 | Experimental | Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy. |
|
| Acupuncture - Group 2 | Active Comparator | Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy. |
|
| Standard Care | Other | Standard oral care recommendations. Participants in all groups will receive the same recommendations. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture - Group 1 | Procedure | Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ) | Xerostomia Questionnaire (XQ), an 8-item questionnaire where subjects rate each symptom on an 11-point ordinal Likert scale from 0 to 10, with higher scores indicating greater dryness or discomfort due to dryness. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Cohen, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Fudan University Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41723882 | Derived | Ratcliff CG, Ahn A, Custodio AL, Garcia MK, Meng Z, Rosenthal DI, Shen Y, Chambers MS, Hu C, Cohen L. The differential effects of social support on quality of life in head and neck cancer patients in the United States and China. Eur J Oncol Nurs. 2026 Apr;81:103156. doi: 10.1016/j.ejon.2026.103156. Epub 2026 Feb 20. | |
| 31808921 | Derived | Garcia MK, Meng Z, Rosenthal DI, Shen Y, Chambers M, Yang P, Wei Q, Hu C, Wu C, Bei W, Prinsloo S, Chiang J, Lopez G, Cohen L. Effect of True and Sham Acupuncture on Radiation-Induced Xerostomia Among Patients With Head and Neck Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1916910. doi: 10.1001/jamanetworkopen.2019.16910. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Acupuncture - Group 2 | Procedure | Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. |
|
| Standard Care | Other | Standard oral care recommendations. Participants in all groups will receive the same recommendations. |
|
| Questionnaire | Other | Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy. |
|
| Shanghai |
| China |
| D010608 |
| Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |