Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Disease Progression

Disease Attributes

Antiemetics

Central Nervous System Depressants

Psychotropic Drugs

Gastrointestinal Agents

All Drugs and Chemicals

Olanzapine

Antipsychotic Agents

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

Patients receive olanzapine 2.5mg PO until disease progression. Intervention: Patients received olanzapine and nutritional advice and standard antitumor treatment.

No Intervention: Patients received nutritional advice and standard anti-tumor treatment.

Oral olanzapine 2.5 mg once daily at bedtime until disease progression

Olanzapine 2.5 MG

Clinicians choose the appropriate standard antitumor drug therapy based on the patient's specific situation

Standard anti-tumor treatment

All patients enrolled in the study were required to undergo a nutritional assessment and were provided with nutritional advice based on their condition

Nutritional advice

Qiuxia Dong, Dr

This study aims to assess the impact of adding olanzapine to nutritional advice and standard anti-tumor therapy on the survival and safety of patients with locally advanced, unresectable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer, and lung cancer. Researchers seek to determine whether olanzapine can improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in advanced cancer patients who received standard anti-tumor therapy, and investigate the relationship between olanzapine-induced weight changes and patient survival.

This study is a prospective, randomized, multicenter, open-label clinical trial to evaluate the effect of olanzapine on survival in patients with locally advanced, unresectable, or metastatic gastric, esophageal, hepato-pancreaticobiliary, and lung cancer. Patients who meet the inclusion and exclusion criteria will be formally enrolled after screening and signing an informed consent form. Eligible patients will be dynamically randomized in a 1:1 ratio to either the Olanzapine + Nutritional advice + Standard anti-tumor treatment group (ONS group) or the Nutritional advice + Standard anti-tumor treatment group (NS group). The ONS group will receive olanzapine treatment orally until disease progression. Survival outcomes, including median PFS, OS, and ORR, will be monitored during treatment through follow-up assessments.

In addition, baseline and post-treatment weight data will be collected to assess the incidence of weight loss and changes in body mass index (BMI) among patients. Researchers will collect survey questionnaires and conduct blood analyses to evaluate improvements in other symptoms associated with olanzapine and changes in quality of life and inflammatory markers. Primary and secondary study outcomes and adverse events will be assessed.

Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer

Survival With the Addition of Olanzapine to Anticancer Therapy in Patients With Locally Advanced, Unresectable or Metastatic Gastric, Esophageal, Hepatopancreaticobiliary and Lung Cancer: a Randomized Clinical Trial

PFS was defined as the time between the start of treatment in this study and the onset of (any aspect of) tumor progression or death (from any cause). Assessment through the RECICT 1.1 version of solid tumors

OS was defined as the time from the start of randomization to death due to any cause. Assessment through the RECICT 1.1 version of solid tumors

ORR was defined as the proportion of patients with advanced disease who achieved complete or partial remission after treatment. Assessment through the RECICT 1.1 version of solid tumors

Patients will receive weight measurements every 2 cycles. Over a 2-year period, the incidence of ≥3% weight loss until progression between the two groups will be assessed based on patients' baseline and post-treatment measurements to determine the efficacy of the drug.

The BMI will be calculated by dividing weight in Kg with the square of the body height (in m2), and is expressed in units of kg/m2. Weight will be recorded by a high quality calibrated digital scale. Participants would be instructed to keep light cloths according to their comfort and no foot-ware. Weight will be expressed in kilograms (Kg) and same machine will be used during each recoding, preferably during the same hour of the day. Height will be measured using a stadiometer, in centimeters (cm) using the metric system. Comparison of BMI (BMI \<20 kg/m2; BMI 20-25 kg/m2; BMI \>25 kg/m2) between the two groups

Patients will be asked to fill the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia/Cachexia Subscale (A/CS) questionnaire (investigator assisted) for the other symptoms both validated with a set cut-off values before start of chemotherapy treatment and after every 2 weeks. These instruments will be presented to the patients on paper and assistance will be offered if required. Both instruments will be filled out based on the patient's experience regarding their appetite during the last 7 days. The 12 items of the FAACT-A/CS are scored on a five-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much). The scores of negatively worded items should be reversed. The sum score ranges from 0 to 48, whereby a lower score indicates less appetite. For scoring the FAACT-A/CS, the FACIT manual will be applied. The cut-off values of ≤37 on the FAACT-A/CS had the highest predictive values.

Assessment through the EuroQol Five Dimensions Questionnaire (EQ-5D). EQ-5D is a standardized instrument used for assessing an individual's health-related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels that describe the person's level of functioning or well-being in that specific area. Additionally, EQ-5D includes a visual analog scale where individuals rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health)

Comparing the difference in Changes in inflammatory factor neutrophil-to-lymphocyte ratio

Comparing the difference in Changes in inflammatory factor

Comparing the difference in Changes in inflammatory factor , through the examination of blood profiles

The proportion of side effects related to olanzapine treatment in patients evaluated by Common Terminology Criteria for adverse events Version 5.0

Spots Global Cancer Trial Database for nutritional advice