Head and Neck CancerNCT00862550
Xerostomia Pilot Fudan: Acupuncture for Prevention of Radiation-Induced Xerostomia
A study testing Acupuncture in people with Head and Neck Cancer and Xerostomia, run by M.D. Anderson Cancer Center at 1 site in China.
Trial summary
PRIMARY AIM 1. Determine the feasibility of providing true and sham acupuncture treatment to patients at Fudan University Cancer Hospital (Cancer Hospital) who are receiving radiation treatment for cancer of the head and/or neck area. SECONDARY AIMS 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Xerostomia
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Mar 2022
- 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
None listed.
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).
- Prior head and neck radiation treatment
- Suspected or confirmed physical closure of salivary gland ducts on either side
- Known bleeding disorders or 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
Show all 14Show fewer
- 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 amifostine, cholinergic agonist medication (Pilocarpine, Cevimeline), beta adrenergic antagonists, anticholinergic agents, saliva substitutes or other medications known to affect salivary function
- Currently receiving acupuncture for any condition
- Prior use of acupuncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Pilot Trial of Acupuncture for Prevention of Radiation-Induced Xerostomia
PRIMARY AIM
- Determine the feasibility of providing true and sham acupuncture treatment to patients at Fudan University Cancer Hospital (Cancer Hospital) who are receiving radiation treatment for cancer of the head and/or neck area. SECONDARY AIMS
- Determine if true acupuncture is more effective than sham acupuncture for preventing radiation-induced xerostomia among cancer patients at Cancer Hospital.
- Determine if true acupuncture is more effective than sham acupuncture for reducing the severity of radiation-induced xerostomia.
Read the detailed description
Acupuncture is the use of very thin needles that are stuck in your skin at certain areas of the body, acupuncture is believed to affect bodily function.
Screening Tests:
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
- You will complete 3 short questionnaires about your quality-of-life and current saliva flow. It will take about 5 minutes to complete all the questionnaires.
- Two (2) saliva samples will be collected. To collect the first saliva sample, you will 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 wait 5 minutes and then hold a sour liquid in your mouth for 1 minute. Then a second saliva sample will be collected.
- A traditional Chinese medicine diagnosis will be performed. During this diagnosis, your pulse will be checked and photographs of your tongue will be taken. You will not be able to be identified by the photos. The photos will be destroyed when the study is complete. This will allow a more objective check of your tongue condition.
- Women who are able to become pregnant must have a negative urine pregnancy test.
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other options will be discussed with you.
Study Groups:
If you are found to be eligible to take part in the study, you will be randomly assigned (as in the flip of a coin) into 1 of 2 groups. Both groups will have acupuncture sessions for 20 minutes before radiation therapy treatments.
- If you are in Group 1, you will have the needles stuck in areas that are known to help dry mouth.
- If you are in Group 2, you will have the needles stuck in areas that are not known to help dry mouth.
When the study is over, participants in Group 2 will be offered 1 week of acupuncture (3 treatments) in the areas known to help dry mouth.
Acupuncture:
All acupuncture sessions will be done before your radiation therapy 3 days a week for 7 weeks. The acupuncturist will put in the needles in certain areas of your body (including your chin, wrist, leg, and ear) while you are lying on a bed. The needles will remain in your body for about 20 minutes.
Study Visits:
Both groups will have the following tests and procedures performed before each acupuncture treatment, once a week:
- Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured.
- You will be asked about any drugs you may be taking.
- You will complete the same questionnaires that you filled out during the screening tests.
Saliva samples will be collected on Weeks 1, 3, 4, 6, and 7. The samples will be collected the same way as done in screening. The samples will be collected after the acupuncture sessions on Weeks 1, 4, and before the acupuncture on Weeks 3 and 6.
You will have the Chinese medicine diagnosis on Weeks 3 and 7.
Length of Study:
You will be on study for 11 weeks. You will be taken off study if the condition gets worse or if intolerable side effects occur. You will be taken off study if you take any drugs for dry mouth.
End-of-Study Visit:
You will have an end-of-study visit 1 month after your last radiation treatment (Week 11). The following tests and procedures will be performed:
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking.
- You will complete the quality-of-life and saliva flow questionnaires.
- You will have the 2 saliva samples a saliva sample will be collected.
- You will have the Chinese medicine diagnosis.
This is an investigational study. Up to 23 patients will take part in this study. All will be enrolled at the Fudan University Cancer Hospital.
- Conditions
- Head and Neck Cancer, Xerostomia
- Being tested
- Acupuncture
- Keywords
- Head and Neck Cancer, HNC, Nasopharyngeal carcinoma, Acupuncture, Radiation-Induced Xerostomia, Xerostomia, Dry Mouth, Radiation
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
20 Minute Acupuncture Sessions Before Radiation Therapy Treatment, 3 Days Per Week for 7 Weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Acupuncture (Areas known to help dry mouth) Receives: Other: Acupuncture |
| Group 2 | Experimental | Acupuncture (Areas not known to help dry mouth) Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Recruitment (#)
Feasibility determined by how many eligible patients approached consented to be in the trial and patients' reported satisfaction with the study
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph S. Chiang, MD, MS, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862550
- Sponsor's protocol ID
- 2008-0801
- Other IDs
- NCI-2009-01558
- Status last verified
- Dec 2020
- First submitted
- 16 Mar 2009
- Last updated
- 30 Dec 2020
- 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 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Trial of Acupuncture for Prevention of Radiation-Induced Xerostomia
- ClinicalTrials.gov ID
- NCT00862550
- Acronym / sponsor ID
- 2008-0801
- Conditions
- Head and Neck Cancer, Xerostomia
- Keywords
- Head and Neck Cancer, HNC, Nasopharyngeal carcinoma, Acupuncture, Radiation-Induced Xerostomia, Xerostomia, Dry Mouth, Radiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 17 Mar 2009 (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.
PRIMARY AIM
- Determine the feasibility of providing true and sham acupuncture treatment to patients at Fudan University Cancer Hospital (Cancer Hospital) who are receiving radiation treatment for cancer of the head and/or neck area. SECONDARY AIMS
- Determine if true acupuncture is more effective than sham acupuncture for preventing radiation-induced xerostomia among cancer patients at Cancer Hospital.
- Determine if true acupuncture is more effective than sham acupuncture for reducing the severity of radiation-induced xerostomia.
Detailed description
Acupuncture is the use of very thin needles that are stuck in your skin at certain areas of the body, acupuncture is believed to affect bodily function.
Screening Tests:
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
- You will complete 3 short questionnaires about your quality-of-life and current saliva flow. It will take about 5 minutes to complete all the questionnaires.
- Two (2) saliva samples will be collected. To collect the first saliva sample, you will 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 wait 5 minutes and then hold a sour liquid in your mouth for 1 minute. Then a second saliva sample will be collected.
- A traditional Chinese medicine diagnosis will be performed. During this diagnosis, your pulse will be checked and photographs of your tongue will be taken. You will not be able to be identified by the photos. The photos will be destroyed when the study is complete. This will allow a more objective check of your tongue condition.
- Women who are able to become pregnant must have a negative urine pregnancy test.
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other options will be discussed with you.
Study Groups:
If you are found to be eligible to take part in the study, you will be randomly assigned (as in the flip of a coin) into 1 of 2 groups. Both groups will have acupuncture sessions for 20 minutes before radiation therapy treatments.
- If you are in Group 1, you will have the needles stuck in areas that are known to help dry mouth.
- If you are in Group 2, you will have the needles stuck in areas that are not known to help dry mouth.
When the study is over, participants in Group 2 will be offered 1 week of acupuncture (3 treatments) in the areas known to help dry mouth.
Acupuncture:
All acupuncture sessions will be done before your radiation therapy 3 days a week for 7 weeks. The acupuncturist will put in the needles in certain areas of your body (including your chin, wrist, leg, and ear) while you are lying on a bed. The needles will remain in your body for about 20 minutes.
Study Visits:
Both groups will have the following tests and procedures performed before each acupuncture treatment, once a week:
- Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured.
- You will be asked about any drugs you may be taking.
- You will complete the same questionnaires that you filled out during the screening tests.
Saliva samples will be collected on Weeks 1, 3, 4, 6, and 7. The samples will be collected the same way as done in screening. The samples will be collected after the acupuncture sessions on Weeks 1, 4, and before the acupuncture on Weeks 3 and 6.
You will have the Chinese medicine diagnosis on Weeks 3 and 7.
Length of Study:
You will be on study for 11 weeks. You will be taken off study if the condition gets worse or if intolerable side effects occur. You will be taken off study if you take any drugs for dry mouth.
End-of-Study Visit:
You will have an end-of-study visit 1 month after your last radiation treatment (Week 11). The following tests and procedures will be performed:
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking.
- You will complete the quality-of-life and saliva flow questionnaires.
- You will have the 2 saliva samples a saliva sample will be collected.
- You will have the Chinese medicine diagnosis.
This is an investigational study. Up to 23 patients will take part in this study. All will be enrolled at the Fudan University Cancer Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: AcupunctureAcupuncture (Areas known to help dry mouth) |
| Group 2 | Experimental | Other: AcupunctureAcupuncture (Areas not known to help dry mouth) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
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).
- Prior head and neck radiation treatment
- Suspected or confirmed physical closure of salivary gland ducts on either side
- Known bleeding disorders or 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 |
|---|---|---|
| Acupuncture20 Minute Acupuncture Sessions Before Radiation Therapy Treatment, 3 Days Per Week for 7 Weeks. | Other | Group 1, Group 2 |
Primary outcome
Subject Recruitment (#)
Time frame: 2 Years
Feasibility determined by how many eligible patients approached consented to be in the trial and patients' reported satisfaction with the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- 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.
Joseph S. Chiang, MD, MS, BS 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 Head and Neck Cancer and Xerostomia, 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 0 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: status not confirmed, as of the sponsor's last update on 30 Dec 2020. 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?
Results are not available in the source record.
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?
Subject Recruitment (#) (time frame: 2 Years). 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 30 Dec 2020.