Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430378
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2007-01-30
Brief Title:
Acupuncture for Prevention of Radiation-Induced Xerostomia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Acupuncture for Prevention of Radiation-Induced Xerostomia
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 andor neck area
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U19CA121503 | NIH | NCI CTRP | httpsreporternihgovquickSearchU19CA121503 |
| NCI-2012-02115 | REGISTRY | None | None |