Terminal phase of Cancer
Conditions
Interventions
ENSURE LIQUID (EL arm) Nutritional support using EL starts when a patient'
s oral intake decreases less than 10% of normal amount of intake. The intake of foods other than EL is permitted during the nutritional support. Div support starts when a patient'
s oral intake decreases less than 125ml/day. The intakes of EL and normal meals are permitted during Div support.
ENSURE LIQUID and Inner Power (EL+ IP arm) Nutritional support using EL starts when a
s oral intake decreases less than 10% of normal amount of intake. The intake of foods other than EL is permitted during the nutritional support. Nutritional support using IP starts when a patient'
s oral intake of EL or normal meals decreases less than 125ml/day. The intakes of EL and normal meals are permitted during nutritional support using IP. Div support starts when a patient'
s oral intake decreases less than 125ml/day. The intakes of EL, IP and normal meals are permitted during Div support.
Inner Power (IP arm) Nutritional support using IP starts when a patient'
s oral intake decreases less than 10% of normal amount of intake. The intake of foods other than IP is permitted during the nutritional support. Div support starts when a patient'
s oral intake decreases less than 125ml/day. The intakes of IP and normal meals are permitted during Div support.
Sponsors
Interfaculty Initiative in Information Studies, The University of Tokyo Department of Palliative Medicine, The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who signed a written informed consent 2) Age 20 or older 3) The cancer notification was given 4) Patients who have the cancer that is incurable neither by operation, radiation therapy nor chemotherapy. 5) Patients who are able to orally intake foods. 6) Patients who are expected to survive more than 2 weeks. 7) ECOG PS between 1 to 3 8) Patients who are in the hospital or able to be hospitalized.
Exclusion criteria
Exclusion criteria: 1) Patients who are diagnosed as solid carcinoma and have dysphagia 2) Patients who have the problem in cognitive functions 3) Patients who have allergies towards the milk constituents and soy beans
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Div free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| The period of nutritional support The period from the start of nutritional support to death The period from the start of Div to death The used amount of EL and IP (caloric intake) The burden of medical expenses Level of consciousness (Glasgow Coma Scale) Health related QOL Digestive symptoms Extraneous factors of ingestion | — |
Countries
Japan
Contacts
Public ContactTempei, MIYAJI
The University of Tokyo Department of Clinical Trial Data Management, Graduate School of Medicine
Outcome results
None listed