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A prospective observational study about fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy

A prospective observational study about fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy - A observational study about fatigue in patients who receive nab-paclitaxel plus gemcitabine therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000021758
Enrollment
10
Registered
2016-04-04
Start date
2016-04-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with unresectable pancreatic cancer

Interventions

None listed

Sponsors

Wakayama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patient with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine 2)Patient with pancreatic cancer stage UICC TNM classification III-IV 3)Estimated overall survival>3months 4)ECOG-PS 0 or 1 5)Main organs function test almost within normal range: WBC>=3,500/mm3, <=12,000/mm3 Neutrophil>=1,500/mm3 Platelet>=100,000/mm3 Hemoglobin>=9.0g/dl AST, ALT<=100IU/l Total bilirubin<=2.0mg/dl,In biliary drainage cases<3.0mg/dl Creatinine<=1.2mg/dl 6)Age>=20 years old 7)Outpatient clinic patient 8)Informed concent was obtained

Exclusion criteria

Exclusion criteria: 1)Patients with severe co-morbidity such as heart failure, renal failure, or bowel obstruction. 2)Patients with pregnancy. 3)Patients with active cancer of other organs. 4)Patients with intorerable of oral medications. 5)Patients who is not suitable for undergoing the study safely.

Design outcomes

Primary

MeasureTime frame
Evaluation of fatigue using FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) score untill eight weeks after stating chemotherapy.

Secondary

MeasureTime frame
Evaluation of appetite loss using NRS(Numerical Rating Scale), peripheral neuropathy using PNQ(Patient Neurotoxicity Questionnaire), sensitive disorders using NRS, nutritional data, anemia using CTCAE criteria, accomplishment of chemotherapy schedule, usage rate of G-CSF, steroids etc., and overall survival.

Countries

Japan

Contacts

Public ContactKen-ichi Okada

Wakayama Medical University Second Department of Surgery

okada@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026