Nutrition Impact on Immunotherapy of Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQingdao Central Hospital
About this trial
This study investigates nutritional status and outcomes of immuntherapy in cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Megestrol Acetate and olanzapine
Drugmegestrol acetate, 160 mg, oral everyday; olanzapine 2.5 mg, oral everyday
Starch powder 50 mg
DrugStarch powder 50 mg, oral, everyday
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: megestrol acetate-olanzapineExperimental treatment 1 intervention
Group B: controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
ORR
overall response rate
Time frame
12 monthsSecondary outcomes
1
PFS
profression-free survival
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov