Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01589328
• Date of registration: 25/04/2012
• Prospective Registration: No
• Primary sponsor: National Cancer Center, Korea
• Public title: Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB EPADE-PB
• Scientific title: Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
• Date of first enrolment: March 15, 2012
• Target sample size: 288
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01589328
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Biliary Tract Cancer

Cancer Pain

Depression

Pancreatic Cancer

Intervention(s)

Other: Early Palliative care integrated with usual oncologic care

Primary Outcome(s)

Reduction in depression score [Time Frame: at baseline, 1 month, and every 3 months, up to 1 year]

Reduction in pain score [Time Frame: at baseline, 1 month, and every 3 months, up to 1 year]

Secondary Outcome(s)

Overall survival [Time Frame: at baseline, 1 month, and every 3 months, up to 1 year]

Quality of life [Time Frame: at baseline, 1 month, and every 3 months, up to 1 year]

Secondary ID(s)

NCCCTS-12-605

Source(s) of Monetary Support

Please refer to primary and secondary sponsors