Head And Neck CancerPhase 3NCT01266044
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
A Phase 3 study testing Acupuncture - Group 1, Acupuncture - Group 2 and Questionnaire in people with Head And Neck Cancer, run by M.D. Anderson Cancer Center at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head And Neck Cancer
- What is being tested?
- Acupuncture - Group 1, Acupuncture - Group 2 and Questionnaire
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Dec 2011to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and be able to give informed consent.
- Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson.
- Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy).
- Anatomically intact parotid and submandibular glands.
- Karnofsky performance status > 60.
Who cannot join
- History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia.
- Prior head and neck radiation treatment.
- Suspected or confirmed physical closure of salivary gland ducts on either side.
- Known bleeding disorders or taking any dose of warfarin or heparin.
- Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
- Local skin infections at or near the acupuncture sites or active systemic infection.
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- History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity.
- Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.
- Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria.
- Current acknowledged use of amifostine, cholinergic agonist medications (pilocarpine, cevimeline), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function (see Appendix F).
- Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the detailed description
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:
- Your vital signs will be recorded.
- You will be asked about any drugs you are taking.
- You will complete 9 questionnaires about your dry mouth, quality of life, and mood. It should take about 30 minutes in total to complete the questionnaires. If you are not able to complete the questionnaires during your regularly scheduled visits, you will be able to take the questionnaires home to complete them and will be given a postage-paid return envelope to mail them back to the study doctor.
- A saliva sample will be collected to measure the quality and amount of saliva produced during radiotherapy.
- You will complete a form about your oral hygiene that should take about 5 minutes to 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.
- Conditions
- Head And Neck Cancer
- Being tested
- Acupuncture - Group 1, Acupuncture - Group 2, Standard Care, Questionnaire
- Keywords
- Radiation-induced xerostomia, Acupuncture, Oropharyngeal cancer, Radiation Therapy, IMRT, Dry mouth
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture - Group 1Procedure or surgery
Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment.
Acupuncture - Group 2Procedure or surgery
Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment.
Standard CareOther
Standard oral care recommendations. Participants in all groups will receive the same recommendations.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Acupuncture - Group 1; Other: Standard Care; Other: Questionnaire |
| 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. Receives: Procedure: Acupuncture - Group 2; Other: Standard Care; Other: Questionnaire |
| 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. Receives: Other: Standard Care; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study start9 Dec 2011
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head And Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 435 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266044
- Sponsor's protocol ID
- 2010-0584
- Other IDs
- NCI-2011-00306, R01CA148707-01A1
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2010
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41723882Garcia 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.
PubMed 31808921
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
- ClinicalTrials.gov ID
- NCT01266044
- Acronym / sponsor ID
- 2010-0584
- Conditions
- Head And Neck Cancer
- Keywords
- Radiation-induced xerostomia, Acupuncture, Oropharyngeal cancer, Radiation Therapy, IMRT, Dry mouth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 435 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Dec 2011 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Your vital signs will be recorded.
- You will be asked about any drugs you are taking.
- You will complete 9 questionnaires about your dry mouth, quality of life, and mood. It should take about 30 minutes in total to complete the questionnaires. If you are not able to complete the questionnaires during your regularly scheduled visits, you will be able to take the questionnaires home to complete them and will be given a postage-paid return envelope to mail them back to the study doctor.
- A saliva sample will be collected to measure the quality and amount of saliva produced during radiotherapy.
- You will complete a form about your oral hygiene that should take about 5 minutes to 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture - Group 1 | Experimental | Procedure: Acupuncture - Group 1, Other: Standard Care, Other: QuestionnaireAcupuncture 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 | Procedure: Acupuncture - Group 2, Other: Standard Care, Other: QuestionnaireAcupuncture 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 | Other: Standard Care, Other: QuestionnaireStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and be able to give informed consent.
- Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson.
- Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy).
- Anatomically intact parotid and submandibular glands.
- Karnofsky performance status > 60.
Key exclusion criteria (11 listed)
- History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia.
- Prior head and neck radiation treatment.
- Suspected or confirmed physical closure of salivary gland ducts on either side.
- Known bleeding disorders or taking any dose of warfarin or heparin.
- Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture - Group 1Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. | Procedure or surgery | Acupuncture - Group 1 |
| Acupuncture - Group 2Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. | Procedure or surgery | Acupuncture - Group 2 |
| Standard CareStandard oral care recommendations. Participants in all groups will receive the same recommendations. | Other | Acupuncture - Group 1, Acupuncture - Group 2, Standard Care |
| QuestionnaireBaseline 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. | Other | Acupuncture - Group 1, Acupuncture - Group 2, Standard Care |
Primary outcome
Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ)
Time frame: 4 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 41723882Ratcliff 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.
- Derived from this study: PubMed 31808921Garcia 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Cohen, PHD principal investigator
M.D. Anderson Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture - Group 1, Acupuncture - Group 2 and Questionnaire in people with Head And Neck Cancer, run by M.D. Anderson Cancer Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01266044, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.