Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT02292368
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2014-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia
Status:
COMPLETED
Status Verified Date:
2022-08
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 which areas of the brain respond to acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and neck cancer. Researchers also want to learn if acupuncture can help prevent dry mouth and improve patient quality of life.
Detailed Description:
Dry mouth is a common problem in 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 flip of a coin) into 1 of 2 groups. You will have an equal chance of being in either group.
Group 1 will receive one type of acupuncture for one session and another type of acupuncture for the second session.
Group 2 will receive one type of acupuncture for one session and another type of acupuncture for the second session.
You will not know if you are assigned to Group 1 or Group 2.
Study Visits:
Your acupuncture treatments will be within 3 to 7 days of each other during Weeks 3-5 of your regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.
At each acupuncture session, you will complete 3 questionnaires before each session that ask about dry mouth, any other symptoms you may be having, and your treatment expectations. It should take about 5 minutes total to complete these questionnaires. You will also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.
You will also have an EEG at each acupuncture treatment. The EEG will be recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.
You will give a saliva sample before and after each acupuncture treatment to measure the amount of saliva produced.
Length of Study:
You will remain on study for about 1 week. Your participation in the study will be over after you complete the dry mouth questionnaire after your second acupuncture session.
This is an investigational study.
Up to 50 patients will take part in this multicenter study. Up to 30 will be enrolled at MD Anderson.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) into 1 of 2 groups. You will have an equal chance of being in either group.
Group 1 will receive one type of acupuncture for one session and another type of acupuncture for the second session.
Group 2 will receive one type of acupuncture for one session and another type of acupuncture for the second session.
You will not know if you are assigned to Group 1 or Group 2.
Study Visits:
Your acupuncture treatments will be within 3 to 7 days of each other during Weeks 3-5 of your regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.
At each acupuncture session, you will complete 3 questionnaires before each session that ask about dry mouth, any other symptoms you may be having, and your treatment expectations. It should take about 5 minutes total to complete these questionnaires. You will also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.
You will also have an EEG at each acupuncture treatment. The EEG will be recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.
You will give a saliva sample before and after each acupuncture treatment to measure the amount of saliva produced.
Length of Study:
You will remain on study for about 1 week. Your participation in the study will be over after you complete the dry mouth questionnaire after your second acupuncture session.
This is an investigational study.
Up to 50 patients will take part in this multicenter study. Up to 30 will be enrolled at MD Anderson.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01CA148707 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2015-00350 | REGISTRY | NCI CTRP | View |