XerostomiaNCT00430378
Acupuncture for Prevention of Radiation-Induced Xerostomia
A study testing Acupuncture in people with Xerostomia and Mouth Dryness, run by M.D. Anderson Cancer Center at 1 site in China.
Trial summary
The goal of this clinical research study is to learn if acupuncture is effective in preventing xerostomia (dry mouth) in cancer patients who receive radiation treatment to the head and neck area. Researchers also want to learn whether acupuncture lowers the severity of dry mouth that is experienced by these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Mouth Dryness, Nasopharyngeal Cancer
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to 27 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult >/= 18 year of age and able to sign informed consent
- Diagnosed with nasopharyngeal carcinoma and scheduled to undergo concurrent chemotherapy and radiation treatment
- Treatment plan must include treatment of at least 50 gray bilateral to the parotid
- Must have anatomically intact parotid and submandibular glands
- Karnofsky Performance Status > 60
- If the participant is female and of child bearing potential, must have a negative urine pregnancy test.
Who cannot join
- History of xerostomia prior to the head and neck radiation therapy (Sjögren's disease or other underlying systemic illness known to cause xerostomia).
- Planned IMRT
- Suspected or confirmed physical closure of salivary gland ducts on either side
- Known bleeding disorders and on Heparin or Coumadin
- 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 site or active systemic infection
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- History of cerebrovascular accident or spinal cord injury. (The mechanism of action for acupuncture may be associated with central nervous system (CNS) activity, and patients with CNS pathology may respond differently to treatment than the general population.)
- 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
- Participants who are taking or who have taken any investigational new drug within the last 30 days, or who are planning to take such a drug during the course of the study
- Current acknowledged use of other alternative medicines such as herbal preparations that could affect salivary function. Each patient will be asked for a list of herbal supplements they are currently taking and this will be reviewed on an individual basis. Patients will be excluded if they are taking any herbs known or suspected to affect salivary function
- Participants taking cholinergic agonist medication (Pilocarpine, Cevimeline), beta adrenergic antagonists, anticholinergic agents or other medications known to affect salivary function
- Currently receiving acupuncture for any condition
- No prior head and neck radiation treatment
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical research study is to learn if acupuncture is effective in preventing xerostomia (dry mouth) in cancer patients who receive radiation treatment to the head and neck area. Researchers also want to learn whether acupuncture lowers the severity of dry mouth that is experienced by these patients.
Primary Objective:
Read more
-Investigate if acupuncture is effective in preventing xerostomia among cancer patients at Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment to the head and neck area.
Secondary Objectives:
- Determine whether acupuncture reduces the severity of xerostomia.
- Determine the feasibility of providing acupuncture treatment to patients at Cancer Hospital who are receiving radiation treatment for cancer of the head and/or neck area.
Read the detailed description
Some research suggests that acupuncture may be helpful in stimulating saliva flow in patients with dry mouth caused by radiation treatment. Acupuncture uses very thin needles inserted at certain points on the body that are believed to affect bodily functions.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded, and you will have a physical exam. You will also be asked to complete 3 short questionnaires about your quality-of-life and current saliva flow. These should take about 5 minutes to complete. You will be asked to collect saliva in a vial (small tube or jar) for 5 minutes, by allowing saliva to collect in your mouth and then spitting it into the vial. You will be asked to collect saliva twice at each time point. One collection will be like it is described above. The second collection will be after you have held a sour liquid in your mouth for 1 minute. A traditional Chinese medicine diagnosis will also be conducted. This will include diagnosis by a doctor as well as by using a heart-rate machine and taking a photograph of your tongue. This will allow a more objective check of your heart rate and tongue condition.
If you are found to be eligible to take part in the study, you will be randomly assigned (as in the toss of a coin) into 1 of 2 groups. One group will receive acupuncture during their radiation treatment period, and the other will receive standard care without acupuncture. Participants assigned to the acupuncture group will receive acupuncture for 20 minutes before their radiation therapy session, 3 days a week for 7 weeks. Participants in the standard care group will not receive acupuncture.
If you are in the acupuncture group, you will be asked to come to the acupuncture clinic for the treatment, before your radiation treatment. The acupuncturist will put in the needles in certain points of your body (including the chin, wrist, leg, and ear), while you are seated in a chair. The needles will remain in for about 20 minutes.
If you choose to receive medications for dry mouth at any point while on study, your participation on this study will end.
No matter which group you are assigned to, for each of the 7 weeks you are receiving radiation treatment, your vital signs (your blood pressure and pulse) will be checked, and you will be asked about any medications you are taking. You will also complete questionnaires about your quality-of-life and symptoms. Each questionnaire should take about 5 minutes to complete. A saliva sample will also be collected on Weeks 1, 3, 4, 6, and 7. If you are assigned to the acupuncture group, the saliva sample will be collected after the acupuncture treatment on Weeks 1, 4, and 7 and before the treatment on Weeks 3 and 6. A traditional Chinese medicine diagnosis will also be conducted in the middle of radiation treatment, at the end of treatment, and 1 month later. This will include diagnosis by a physician as well as by using a pulse machine and taking a photograph of your tongue.
One month after the end of radiation treatment (Week 11), your vital signs will be checked, you will be asked about any medications you are taking， you will complete the quality of life and symptom questionnaires, and you will provide another saliva sample. After Week 11, your participation on this study is over.
This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at the Fudan University Cancer Hospital.
- Conditions
- Xerostomia, Mouth Dryness, Nasopharyngeal Cancer
- Being tested
- Acupuncture, Standard Care
- Keywords
- Xerostomia, Dry Mouth, Mouth Dryness, Nasopharyngeal Cancer, Acupuncture
- Medical subject headings
- Xerostomia, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture for 20 minutes before the radiation therapy session, 3 days a week for 7 weeks.
Standard CareOther
No Acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture Before the Radiation Treatment Receives: Procedure: Acupuncture |
| Standard Care | Experimental | Standard Care Without Acupuncture Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Xerostomia
Severity of the xerostomia in both groups compared by testing for group differences in xerostomia scores between baseline and week 7 using a two-sample (unpaired) t test. Repeated measures analyses used in order to detect overall differences in severity over time, differences between groups and the interaction between time and group.
Measured: Baseline + 8 additional points in time (baseline, weeks1-7, week 11).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startJan 2007
- Primary completion27 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- Joseph S. Chiang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430378
- Sponsor's protocol ID
- 2006-0763
- Other IDs
- NCI-2012-02115, U19CA121503
- Status last verified
- Jun 2021
- First submitted
- 30 Jan 2007
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Prevention of Radiation-Induced Xerostomia
- ClinicalTrials.gov ID
- NCT00430378
- Acronym / sponsor ID
- 2006-0763
- Conditions
- Xerostomia, Mouth Dryness, Nasopharyngeal Cancer
- Keywords
- Xerostomia, Dry Mouth, Mouth Dryness, Nasopharyngeal Cancer, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 1 Feb 2007 (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 is effective in preventing xerostomia (dry mouth) in cancer patients who receive radiation treatment to the head and neck area. Researchers also want to learn whether acupuncture lowers the severity of dry mouth that is experienced by these patients.
Primary Objective:
-Investigate if acupuncture is effective in preventing xerostomia among cancer patients at Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment to the head and neck area.
Secondary Objectives:
- Determine whether acupuncture reduces the severity of xerostomia.
- Determine the feasibility of providing acupuncture treatment to patients at Cancer Hospital who are receiving radiation treatment for cancer of the head and/or neck area.
Detailed description
Some research suggests that acupuncture may be helpful in stimulating saliva flow in patients with dry mouth caused by radiation treatment. Acupuncture uses very thin needles inserted at certain points on the body that are believed to affect bodily functions.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded, and you will have a physical exam. You will also be asked to complete 3 short questionnaires about your quality-of-life and current saliva flow. These should take about 5 minutes to complete. You will be asked to collect saliva in a vial (small tube or jar) for 5 minutes, by allowing saliva to collect in your mouth and then spitting it into the vial. You will be asked to collect saliva twice at each time point. One collection will be like it is described above. The second collection will be after you have held a sour liquid in your mouth for 1 minute. A traditional Chinese medicine diagnosis will also be conducted. This will include diagnosis by a doctor as well as by using a heart-rate machine and taking a photograph of your tongue. This will allow a more objective check of your heart rate and tongue condition.
If you are found to be eligible to take part in the study, you will be randomly assigned (as in the toss of a coin) into 1 of 2 groups. One group will receive acupuncture during their radiation treatment period, and the other will receive standard care without acupuncture. Participants assigned to the acupuncture group will receive acupuncture for 20 minutes before their radiation therapy session, 3 days a week for 7 weeks. Participants in the standard care group will not receive acupuncture.
If you are in the acupuncture group, you will be asked to come to the acupuncture clinic for the treatment, before your radiation treatment. The acupuncturist will put in the needles in certain points of your body (including the chin, wrist, leg, and ear), while you are seated in a chair. The needles will remain in for about 20 minutes.
If you choose to receive medications for dry mouth at any point while on study, your participation on this study will end.
No matter which group you are assigned to, for each of the 7 weeks you are receiving radiation treatment, your vital signs (your blood pressure and pulse) will be checked, and you will be asked about any medications you are taking. You will also complete questionnaires about your quality-of-life and symptoms. Each questionnaire should take about 5 minutes to complete. A saliva sample will also be collected on Weeks 1, 3, 4, 6, and 7. If you are assigned to the acupuncture group, the saliva sample will be collected after the acupuncture treatment on Weeks 1, 4, and 7 and before the treatment on Weeks 3 and 6. A traditional Chinese medicine diagnosis will also be conducted in the middle of radiation treatment, at the end of treatment, and 1 month later. This will include diagnosis by a physician as well as by using a pulse machine and taking a photograph of your tongue.
One month after the end of radiation treatment (Week 11), your vital signs will be checked, you will be asked about any medications you are taking， you will complete the quality of life and symptom questionnaires, and you will provide another saliva sample. After Week 11, your participation on this study is over.
This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at the Fudan University Cancer Hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureAcupuncture Before the Radiation Treatment |
| Standard Care | Experimental | Other: Standard CareStandard Care Without Acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult >/= 18 year of age and able to sign informed consent
- Diagnosed with nasopharyngeal carcinoma and scheduled to undergo concurrent chemotherapy and radiation treatment
- Treatment plan must include treatment of at least 50 gray bilateral to the parotid
- Must have anatomically intact parotid and submandibular glands
- Karnofsky Performance Status > 60
Key exclusion criteria (14 listed)
- History of xerostomia prior to the head and neck radiation therapy (Sjögren's disease or other underlying systemic illness known to cause xerostomia).
- Planned IMRT
- Suspected or confirmed physical closure of salivary gland ducts on either side
- Known bleeding disorders and on Heparin or Coumadin
- 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 |
|---|---|---|
| AcupunctureAcupuncture for 20 minutes before the radiation therapy session, 3 days a week for 7 weeks. | Procedure or surgery | Acupuncture |
| Standard CareNo Acupuncture. | Other | Standard Care |
Primary outcome
Number of Patients with Xerostomia
Time frame: Baseline + 8 additional points in time (baseline, weeks1-7, week 11).
Severity of the xerostomia in both groups compared by testing for group differences in xerostomia scores between baseline and week 7 using a two-sample (unpaired) t test. Repeated measures analyses used in order to detect overall differences in severity over time, differences between groups and the interaction between time and group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- UT 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.
Joseph S. Chiang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Xerostomia and Mouth Dryness, run by M.D. Anderson Cancer Center at 1 site in China.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Patients with Xerostomia (time frame: Baseline + 8 additional points in time (baseline, weeks1-7, week 11).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2021.