Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00040833
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00040833
Study Brief:
Protocol Section:
NCT00040833