Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040833
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-07-08
Brief Title:
Acupuncture and Acupressure in Treating Patients With Moderate or Severe Pain Related to Stage III or Stage IV Pancreatic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Acupuncture for the Treatment of Pancreatic Cancer Pain A Single Arm Phase II Study
Status:
COMPLETED
Status Verified Date:
2013-06
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 and acupressure may help relieve moderate or severe pain associated with stage III or stage IV pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of acupuncture and accupressure in treating patients who have moderate or severe pain associated with stage III or stage IV pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of acupuncture and accupressure in treating patients who have moderate or severe pain associated with stage III or stage IV pancreatic cancer
Detailed Description:
OBJECTIVES
Assess the effects of acupuncture and acupressure on pain sedation and use of opiate medication in patients with moderate or severe pain related to stage III or IV pancreatic cancer
Determine whether controlled trials of this therapy are warranted in this patient population
Provide data to aid design of further warranted studies of this therapy in this patient population
OUTLINE Patients receive acupuncture treatment comprising 20 minutes of needle insertion into the arms and abdomen to the depth used in traditional Chinese medicine on approximately days 4 7 11 and 14 After each acupuncture treatment the acupuncturist appliesreapplies acupressure devices by inserting 2-6 smaller needles studs into the abdomen which are held in place with surgical tape and taping tiny metal balls to 3 points in each ear Patients or caregivers are instructed to administer acupressure by pressing on the ear points metal balls for 1-2 minutes per point and moving the semi-permanent abdominal needles in small circular movements with the fingers at a rate of 2-3 cycles per second for 1-2 minutes per point upon waking in the morning and in the early afternoon Patients or caregivers are also instructed to stimulate a rescue point the Shenmen auricular point if patients experience pain exacerbations at other times during the day Patients who respond well to acupuncture are offered further treatment
Pain is assessed using the numerical rating scale on approximately days 1-4 7 11 and 14-17 Sedation is assessed using the Profile of Mood States POMS on approximately days 3 and 17 Analgesic medication use is assessed on approximately days 1-3 and 15-17
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within approximately 2 years
Assess the effects of acupuncture and acupressure on pain sedation and use of opiate medication in patients with moderate or severe pain related to stage III or IV pancreatic cancer
Determine whether controlled trials of this therapy are warranted in this patient population
Provide data to aid design of further warranted studies of this therapy in this patient population
OUTLINE Patients receive acupuncture treatment comprising 20 minutes of needle insertion into the arms and abdomen to the depth used in traditional Chinese medicine on approximately days 4 7 11 and 14 After each acupuncture treatment the acupuncturist appliesreapplies acupressure devices by inserting 2-6 smaller needles studs into the abdomen which are held in place with surgical tape and taping tiny metal balls to 3 points in each ear Patients or caregivers are instructed to administer acupressure by pressing on the ear points metal balls for 1-2 minutes per point and moving the semi-permanent abdominal needles in small circular movements with the fingers at a rate of 2-3 cycles per second for 1-2 minutes per point upon waking in the morning and in the early afternoon Patients or caregivers are also instructed to stimulate a rescue point the Shenmen auricular point if patients experience pain exacerbations at other times during the day Patients who respond well to acupuncture are offered further treatment
Pain is assessed using the numerical rating scale on approximately days 1-4 7 11 and 14-17 Sedation is assessed using the Profile of Mood States POMS on approximately days 3 and 17 Analgesic medication use is assessed on approximately days 1-3 and 15-17
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within approximately 2 years
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 |
|---|---|---|---|
| CDR0000069411 | REGISTRY | None | None |
| NCI-G02-2082 | Registry Identifier | PDQ Physician Data Query | None |