NCT00040833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

July 8, 2002

Last Update Submit

June 4, 2013

Conditions

Keywords

stage III pancreatic cancerrecurrent pancreatic cancerpainstage IV pancreatic cancer

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of stage III or IV primary pancreatic cancer * At least 4 days since prior change in type of pain medication * No change in dose of long-acting analgesics * Actual dose of as needed (PRN) pain medication may vary * One of the following pain scores: * Pain score of at least 4 on a scale of 0 to 10 * A score of at least 54 out of 88 on the combined relevant Profile of Mood States (POMS) subscales (Vigor, Fatigue, and Confusion) with no evidence that sedation results from cause other than opiate medication and patient reported using PRN opiates on at least 4 of the past 7 days (patients who are eligible for this study on the basis of POMS scores must be taking PRN medication) PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Not specified Life expectancy: * At least 4 weeks Hematopoietic: * Absolute neutrophil count at least 500/mm\^3 * Platelet count at least 20,000/mm\^3 Hepatic: * INR no greater than 2.5 Renal: * Not specified Cardiovascular: * No heart valve dysfunction Other: * No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior gemcitabine unless there is documented disease progression * Concurrent chemotherapy (except gemcitabine) allowed Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * At least 1 week since prior epidural analgesia, celiac plexus block, or thoracoscopic or open splanchnicectomy * No concurrent epidural analgesia, celiac plexus block, or thoracoscopic or open splanchnicectomy Other: * See Disease Characteristics * At least 3 months since prior acupuncture * Concurrent experimental treatments allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

PainPancreatic Neoplasms

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Barrie R. Cassileth, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

February 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations