Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer (NCT02589938) | Clinical Trial Compass
CompletedNot Applicable
Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer
United States258 participantsStarted 2012-11-11
Plain-language summary
This study is being done to find out what effects, good and/or bad, acupuncture has on participants and their xerostomia caused by radiation therapy for the treatment of the cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must be at least 18 years of age and able to give informed consent.
* Must be able to read, write and understand English.
* Must have a diagnosis of head/neck cancer.
* Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified Radiation Therapy Oncology Group (RTOG) scale:
* Grade 0 - None
* Grade 1 - Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary)
* Grade 2 - Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods)
* Grade 3 - Complete dryness of mouth (no response on stimulation and difficult oral alimentation; IV fluids, pureed diet or tube feedings may be required)
* Grade 4 - Fibrosis
* Must have received external beam radiation at a mean dose of at least 24 Gy to one of the parotid glands. The other gland can receive less than 24 Gy.
* Must have completed radiotherapy at least 12 months prior to entry.
* Must have anatomically intact parotid and submandibular glands. A focused (head/neck) history and exam conducted by a physician or dentist within the past year is required.
* Must be acupuncture naïve.
* Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion Criteria:
* History of xerostomia, Sjogren's disease or other illness known to affect salivation prior to head/neck radiation.
* Suspec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Xerostomia Questionnaire Scores
Timeframe: Baseline to 4, 8, 12, 26 weeks post acupuncture