Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090337
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
2004-08-25
Brief Title:
Acupuncture or Standard Therapy in Treating Pain and Dysfunction in Patients Who Have Undergone Neck Surgery for Head and Neck Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Acupuncture for Pain and Dysfunction Following Neck Dissection A Randomized Controlled Phase III Trial
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 dysfunction in patients who have undergone neck surgery for head and neck cancer
PURPOSE This randomized phase III trial is studying acupuncture to see how well it works compared to standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer
PURPOSE This randomized phase III trial is studying acupuncture to see how well it works compared to standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21CA098792 | NIH | None | None |
| P30CA008748 | NIH | None | None |
| MSKCC-03131A | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |