Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial
acupuncture therapy
+ standard follow-up care
Head and Neck Neoplasms
+ Neoplasms
+ Neoplasms by Site
Supportive Care Study
Summary
Study start date: November 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine whether acupuncture reduces pain and dysfunction in patients with head and neck cancer who have undergone neck dissection. Secondary * Determine whether acupuncture relieves dry mouth in these patients. OUTLINE: This is a randomized, controlled study. Patients are stratified according to surgical procedure (selective neck dissection vs modified radical neck dissection vs radical neck dissection) and baseline Constant-Murley score (≤ 35 vs > 35). Patients are randomized into 1 of 2 treatment arms. * Arm I: Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks. * Arm II: Patients undergo standard of care for 4 weeks. In both arms, treatment continues in the absence of unacceptable toxicity. The Constant-Murley score is assessed at baseline and then at week 6. Pain medication use is recorded at baseline, during study treatment, and then at week 6. Numerical Rating Scale of pain on activity and xerostomia inventories are completed at baseline and then at weeks 5 and 6. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.73 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Must have undergone neck dissection for cancer ≥ 3 months ago (in order to qualify pain as chronic sequella) * Subjective complaint of pain and/or dysfunction in the neck and/or shoulders that, in the opinion of the investigator, is due to neck dissection * Constant-Murley score ≤ 70 (i.e., moderate or severe pain and dysfunction) * No moderate or severe neck or shoulder pain that, in the opinion of the investigator, is not due to cancer surgery PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 months since prior radiotherapy * More than 6 weeks since prior acupuncture * Concurrent analgesics allowed
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location