Cancer, Immunotherapy, Nutrition Disorders, Survival, Prosthesis
Conditions
Brief summary
This study investigates nutritional status and outcomes of immuntherapy in cancer patients.
Detailed description
Studies have shown that more than half of the patients with cancer are also malnourished at diagnosis. This increases patients' risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates.
Interventions
DRUGMegestrol Acetate and olanzapine
megestrol acetate, 160 mg, oral everyday; olanzapine 2.5 mg, oral everyday
DRUGStarch powder 50 mg
Starch powder 50 mg, oral, everyday
Sponsors
Qingdao Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Malnourished patients with megestrol acetate 160mg oral, olanzapine 2.5mg oral, everyday during the immunotherapy course or intolerable.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of cancer, malnutrition Age \>18 years Performance status ECOG of 0 or 2. Life expectancy ≥ 6 months. At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1) Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment Postmenopausal or evidence of non-childbearing status for women of childbearing potential Patient is willing and able to comply with the protocol for the duration of the study. For all oral medications patients must be able to comfortably swallow capsules;
Exclusion criteria
* Patients unable to swallow orally administered medication and patients with Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs History of allogenic organ, bone marrow or double umbilical cord blood transplantation. Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 12 months | overall response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 12 months | profression-free survival |
Countries
China
Contacts
Primary ContactKeke Nie, MD
Outcome results
None listed