UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective observational study about fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy
Title of the study (Brief title)	A observational study about fatigue in patients who receive nab-paclitaxel plus gemcitabine therapy
Region	Japan

Condition
Condition	Patients with unresectable pancreatic cancer
Classification by specialty	Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluate fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy using several scores.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of fatigue using FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) score untill eight weeks after stating chemotherapy.
Key secondary outcomes	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.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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.
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroki Yamaue
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama
TEL	073-447-2300
Email	yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person	Ken-ichi Okada
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama
TEL	073-441-0613
Homepage URL
Email	okada@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 03 Day
Anticipated trial start date	2016 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design: prospective observation study. Method of recruiting: patientswho present outpatient clinic of Wakayama Medical University Hospital and eligible to this study. Measurement item: 1. fatigue evaluated by NRS until 8 weeks after first administration 2. appetite loss evaluate by NRS until 8 weeks after first administration 3. peripheral neuropathy evaluated by PNQ until 8 weeks after first administration 4. sensory disturbance evaluated by NRS until 8 weeks after first administration 5. Nutritional status evaluated by albumin, prealbumin, and body weight until 8 weeks after first administration 6. anemia evaluated by CTCAE until 8 weeks after first administration 7. overall survival

Management information
Registered date	2016 Year 04 Month 03 Day
Last modified on	2017 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025091