Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile,
stainless steel needles into the skin at specific points.
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
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
- 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
- You will complete a form about your oral hygiene that should take about 5 minutes to
Length of Study:
You will remain on study for up to 17 months.
This is an investigational study.
Up to 375 patients will take part in this multicenter study. Up to 187 will be enrolled at
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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.
Lorenzo Cohen, PHD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|