Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

Status Active, not recruiting

Clinical Trial Summary

The goal of this clinical research study is to learn if acupuncture can help to prevent xerostomia (dry mouth) and improve the quality of life in patients who receive radiation treatment to the head and neck. This study will determine if one acupuncture treatment approach is more effective than another. Dry mouth is a common problem among cancer patients who have received radiation treatment to the head and neck.

Clinical Trial Description

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 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 treatment period. Study Visits: 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 is complete: - 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 during radiotherapy. - You will complete a form about your oral hygiene that should take about 5 minutes to complete. Length of Study: You will remain on study for up to 17 months. Additional Information: After your participation on this study is complete and you are no longer enrolled in this study, if you were in Group 2 or 3, you will be offered to receive 3 acupuncture treatments. This is an investigational study. Up to 435 patients will take part in this multicenter study. Up to 193 will be enrolled at MD Anderson. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01266044
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	December 9, 2011
Completion date	December 31, 2026

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