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Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer, Biliary Tract Cancer, Cancer Pain, Depression

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Trial Information

Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB


Inclusion Criteria:



- Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

- Pathologic confirmed locally advanced or metastatic pancreatic cancer or biliary
tract cancer

- within 8 weeks after diagnosis

- cancer-related pain (Brief Pain Inventory [BPI] worst pain score >3), depression
(Center for Epidemiological Studies-Depression Scale [CES-D] >16) or both

- Karnofsky Performance Rating Scale ≥50%

Exclusion Criteria:

- Opioid intolerance

- History of drug or alcohol abuse

- Impaired sensory or cognitive function

- Pregnant or lactating woman

- Women of child bearing potential not using a contraceptive method

- Sexually active fertile men not using effective birth control during medication of
study drug and up to 6 months after completion of study drug if their partners are
women of child-bearing potential

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Reduction in pain score

Outcome Description:

• Reduction in pain scores, Brief Pain Inventory [BPI] severity

Outcome Time Frame:

at baseline, 1 month, and every 3 months, up to 1 year

Safety Issue:

No

Authority:

National Cancer Center:Korea

Study ID:

NCCCTS-12-605

NCT ID:

NCT01589328

Start Date:

April 2012

Completion Date:

December 2015

Related Keywords:

  • Pancreatic Cancer
  • Biliary Tract Cancer
  • Cancer Pain
  • Depression
  • pancreatic cancer
  • biliary tract cancer
  • cancer pain
  • depression
  • Depression
  • Depressive Disorder
  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms

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