Acupuncture for Prevention of Radiation-Induced Xerostomia (NCT00430378) | Clinical Trial Compass
CompletedNot Applicable
Acupuncture for Prevention of Radiation-Induced Xerostomia
China100 participantsStarted 2007-01
Plain-language 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 and/or neck area.
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
. Adult \>/= 18 year of age and able to sign informed consent
. Diagnosed with nasopharyngeal carcinoma and scheduled to undergo concurrent chemotherapy and radiation treatment
. Treatment plan must include treatment of at least 50 gray bilateral to the parotid
. Must have anatomically intact parotid and submandibular glands
. Karnofsky Performance Status \> 60
. If the participant is female and of child bearing potential, must have a negative urine pregnancy test.
Exclusion criteria
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
Number of Patients with Xerostomia
Timeframe: Baseline + 8 additional points in time (baseline, weeks1-7, week 11).
. History of xerostomia prior to the head and neck radiation therapy (Sjögren's disease or other underlying systemic illness known to cause xerostomia).
. Planned IMRT
. Suspected or confirmed physical closure of salivary gland ducts on either side
. Known bleeding disorders and on Heparin or Coumadin
. Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory
. Local skin infections at or near the acupuncture site or active systemic infection
. History of cerebrovascular accident or spinal cord injury. (The mechanism of action for acupuncture may be associated with central nervous system (CNS) activity, and patients with CNS pathology may respond differently to treatment than the general population.)
. Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process