Pancreatic cancer
Conditions
Interventions
Participants will be randomized in 2 arms:
(Intervention arm)
Between the chemotherapy start date and the day before surgery, participants will take ENORAS Liquid 187.5 mL twice a day and will perform
Sponsors
Hasegawa Kiyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. With resectable pancreatic cancer scheduled for neoadjuvant chemotherapy, gemcitabine and S-1, and pancreatic resection 2. ASA performance status of 1-2 3. Aged between 18 and 85 years old at the time of informed consent is taken 4. Male or female 5. Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation 6. Able to attend all scheduled visits
Exclusion criteria
Exclusion criteria: 1. Having history of hypersensitivity to component of ENORAS Liquid 2. With milk protein allergy 3. With ileus 4. With loss of bowel function 5. With severe liver diseases, renal diseases or cardiac diseases, judged based on grade 3 of CTCAE v5.0- JCOG 6. Having hemodialysis 7. With disorder of glucose metabolism such as severe diabetes mellitus 8. With congenital disorder of amino acid metabolism 9. Women of childbearing potential, pregnant women or breast-feeding women 10. Disable to having prehabilitation due to impaired cardiopulmonary function 11. Judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in serum cholinesterase level before and after neoadjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amount of change in serum cholinesterase level before and after neoadjuvant chemotherapy, and amount and rate of change in serum albumin, prealbumin, transferrin and HbA1c level before and after neoadjuvant chemotherapy 2. Amount and rate of change in muscle volume before and after neoadjuvant chemotherapy 3. Amount and rate of change in physical function: 6 minute walk test, lower limb power, grip strength, one-leg standing time, locomotive syndrome test, and body composition measured by BIA 4. Amount and rate of change in quality of life before and after surgery 5. Frequency of post-operative complications 6. Duration of hospitalization after surgery 7. Cost of medical care 8. Frequency of adverse events 9. Days from surgery to adjuvant chemotherapy 10. 1-year recurrence rate 11. 1-year survival rate 12. Relapse-free survival 13. Overall survival | — |
Contacts
Public ContactYoshikuni Kawaguchi
The University of Tokyo Hospital
Outcome results
None listed