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Trial Title:
Nutrition Impact on Immunotherapy of Cancer
NCT ID:
NCT06500234
Condition:
Nutrition Disorders
Immunotherapy
Cancer
Survival, Prosthesis
Conditions: Official terms:
Nutrition Disorders
Prosthesis Failure
Megestrol
Megestrol Acetate
Olanzapine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Malnourished patients with megestrol acetate 160mg oral, olanzapine 2.5mg oral, everyday
during the immunotherapy course or intolerable.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Megestrol Acetate and olanzapine
Description:
megestrol acetate, 160 mg, oral everyday; olanzapine 2.5 mg, oral everyday
Arm group label:
megestrol acetate-olanzapine
Intervention type:
Drug
Intervention name:
Starch powder 50 mg
Description:
Starch powder 50 mg, oral, everyday
Arm group label:
control
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qingdao Central Hospital
Address:
City:
Qingdao
Zip:
266042
Country:
China
Status:
Recruiting
Contact:
Last name:
KEKE NIE, MD
Phone:
68665078
Email:
NIEKEKEQD@163.COM
Investigator:
Last name:
Keke Nie, MD
Email:
Principal Investigator
Start date:
June 1, 2024
Completion date:
May 31, 2027
Lead sponsor:
Agency:
Qingdao Central Hospital
Agency class:
Other
Source:
Qingdao Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500234
