Unique ID issued by UMIN | UMIN000021758 |
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Receipt number | R000025091 |
Scientific Title | A prospective observational study about fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy |
Date of disclosure of the study information | 2016/04/04 |
Last modified on | 2017/10/04 12:58:30 |
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
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
Japan |
Patients with unresectable pancreatic cancer
Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Malignancy
NO
We evaluate fatigue in patients with unresectable pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy using several scores.
Safety,Efficacy
Evaluation of fatigue using FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) score untill eight weeks after stating chemotherapy.
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.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
10
1st name | |
Middle name | |
Last name | Hiroki Yamaue |
Wakayama Medical University
Second Department of Surgery
811-1, Kimiidera, Wakayama
073-447-2300
yamaue-h@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Ken-ichi Okada |
Wakayama Medical University
Second Department of Surgery
811-1, Kimiidera, Wakayama
073-441-0613
okada@wakayama-med.ac.jp
Wakayama Medical University
none
Other
NO
2016 | Year | 04 | Month | 04 | Day |
Unpublished
Completed
2016 | Year | 04 | Month | 03 | Day |
2016 | Year | 04 | Month | 04 | Day |
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
2016 | Year | 04 | Month | 03 | Day |
2017 | Year | 10 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025091
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