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RATIONALE: Acupuncture may help relieve dry mouth caused by radiation therapy.
PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared to sham acupuncture or standard therapy in treating dry mouth caused by radiation therapy in patients with head and neck cancer.
- To determine whether acupuncture can symptomatically improve moderate or severe radiation-induced xerostomia (grade 2 or 3) in patients with head and neck cancer.
- To explore the duration of response (up to a maximum of 12 weeks) in the subgroup of patients who report a response to the acupuncture intervention.
OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease, age, sex, the mean of parotid radiotherapy doses received, and baseline Xerostomia Questionnaire scores. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive standard oral hygiene care for 8 weeks, including instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice.
- Arm II: Patients receive acupuncture at 3 sites on each ear, on the chin, on each forearm, and on each leg twice a week for 4 weeks. Patients with minor response may continue treatment for an additional 4 weeks. Patients also receive standard oral hygiene as in arm 1.
- Arm III: Patients receive sham acupuncture twice a week for 4 weeks and standard oral hygiene as in arm 1. Patients with minor response may continue treatment for an additional 4 weeks.
Patients complete Xerostomia Questionnaire (XQ), the M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), and the Functional Assessment of Cancer Therapy (FACT-G) questionnaires at baseline and at the end of weeks 4 and 8. Patients with partial response or minor response, according to week-8 questionnaires, complete XQ, MDASI-HN, and the FACT-G at the end of week 12. Patients in group 2 and 3 also complete the Acupuncture Expectancy Scale (AES).
Allocation: Randomized, Control: Placebo Control, Masking: Single Blind, Primary Purpose: Supportive Care
Head and Neck Cancer
acupuncture therapy, sham intervention, standard follow-up care
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:08:49-0400
RATIONALE: Acupuncture may help relieve pain and dysfunction caused by cancer surgery. It is not yet known whether acupuncture is more effective than standard therapy in treating pain and ...
To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.
This study is for the woman who will have axillary (armpit) surgery as part of their breast cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to contr...
This research study will evaluate the effectiveness of acupuncture in decreasing urinary incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture sessions ove...
The goal of this clinical research study is to compare 3 types of interventions (involving electro-acupuncture and standard care) that are given to women with chronic post-surgical pain af...
Postoperative chemoradiotherapy (CRT) is considered standard of care in patients with locally advanced head and neck cancer with positive margins and/or extracapsular extension (ECE).
Two randomized controlled trials of acupuncture concerning polycystic ovary syndrome (PCOS) and stress urinary incontinence (SUI) were published simultaneously in the 24th issue, 2017 of The Journal o...
The purpose of this pilot study was to examine a therapeutic intervention for head and neck lymphedema. The 22-week intervention involved therapist-led care and participant self-management. Effectiven...
Acupuncture therapy by inserting needles in the ear. It is used to control pain and for treating various ailments.
The occupational discipline of the traditional Chinese methods of ACUPUNCTURE THERAPY for treating disease by inserting needles along specific pathways or meridians.
A type of massage in which finger pressure on specific body sites is used to promote healing, relieve fatigue, etc. Although the anatomical locations are the same as the ACUPUNCTURE POINTS used in ACUPUNCTURE THERAPY (hence acu-), no needle or other acupuncture technique is employed in acupressure. (From Random House Unabridged Dictionary, 2d ed). Shiatsu is a modern outgrowth that focuses more on prevention than healing.
Specialized healthcare delivered as a follow-up or referral from a PRIMARY CARE provider.
A traditional term for all the activities which a physician or other health care professional normally performs to insure the coordination of the medical services required by a patient. It also, when used in connection with managed care, covers all the activities of evaluating the patient, planning treatment, referral, and follow-up so that care is continuous and comprehensive and payment for the care is obtained. (From Slee & Slee, Health Care Terms, 2nd ed)
Complementary and alternative medicine (CAM) is the term for medical products and practices that are not part of standard care. Standard care is what medical doctors, doctors of osteopathy, and allied health professionals, such as nurses and physical the...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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