Evidence map›Paper›PMID 38806870›Full record

Trial reportJournal of cancer research and clinical oncology2024

A prospective randomized controlled clinical trial investigating the efficacy of low-dose olanzapine in preventing nausea and vomiting associated with oxaliplatin-based and irinotecan-based chemotherapy.

Jing Shen, Juan Zhao, Gaowa Jin, Hui Li, Ying Jiang, Yungaowa Wu, Jiali Gao, Feng Chen, Jiaxuan Li, Wenjuan Wang and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06850454 (A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06850454 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy

TypeinterventionalSponsorMahidol UniversityRan2025 to 2026Enrolled140ConditionsChemotherapy Induced Nausea and VomitingArmsolanzapine, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jing Shen *Ordos Clinical College, Baotou Medical College, Ordos, 017000, China.
Juan Zhao *Department of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Dongsheng District, Ordos, 017000, China.
Gaowa JinDepartment of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Dongsheng District, Ordos, 017000, China.
Hui LiDepartment of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Dongsheng District, Ordos, 017000, China.
Ying JiangDepartment of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Dongsheng District, Ordos, 017000, China.
Yungaowa WuDepartment of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Dongsheng District, Ordos, 017000, China.
Jiali GaoDepartment of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Dongsheng District, Ordos, 017000, China.
Feng ChenDepartment of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Dongsheng District, Ordos, 017000, China.
Jiaxuan LiOrdos Clinical College, Inner Mongolia Medical University, Ordos, 017000, China.
Wenjuan WangDepartment of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Dongsheng District, Ordos, 017000, China. wenjuan_wang_wwj@126.com.
Quanfu LiDepartment of Medical Oncology, Ordos Central Hospital, 23th Yijinhuoluo Western Road, Dongsheng District, Ordos, 017000, China. li_qfedu@163.com.

Funding

Inner Mongolia Autonomous Region Talent Development Fund 202265Inner Mongolia natural science foundation 2021MS08133National Clinical Key Specialty Construction Project 2023305
6 · The paper itself

Abstract

objectiveThe aim of this study is to assess the clinical efficacy of a 5 mg dosage of olanzapine in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) among female patients diagnosed with gastrointestinal tract tumors.

methodsPatients undergoing the oxaliplatin/irinotecan chemotherapy regimen were enrolled in this prospective controlled study. The olanzapine group received a 5 mg dosage of olanzapine along with palonosetron and dexamethasone, while the control group received a standard two-combination regimen consisting of dexamethasone and palonosetron. The primary endpoints included the total protection (TP) rates for the entire age group and the subgroup aged 60 years and above. Secondary endpoints encompassed the total protection rates during the acute and delayed phases within the two age brackets, as well as the total control (TC) rates and complete remission (CR) rates across all three phases (total, acute, and delayed). Additionally, the study involved the assessment of quality of life and the collection of adverse events associated with the interventions.

results1) Regarding the primary endpoint, the total phase TP rates within both the entire age group and the age group exceeding 60 years demonstrated superiority in the olanzapine group when compared to the control group (66.7% vs 37.25%, P = 0.003; 68.8% vs 44.4%, P = 0.044). 2) In terms of secondary endpoints, the olanzapine group exhibited superior acute phase TP rates in both age brackets when compared to the control group (P < 0.05). The olanzapine group also demonstrated higher delayed-phase TP rates, TC rates across all three phases, and CR rates within the two age brackets, although the differences were not statistically significant (P > 0.05). Furthermore, the quality of life in the olanzapine group surpassed that of the control group for both age brackets (P < 0.05), characterized by enhanced appetite and a higher incidence of drowsiness in the patients treated with olanzapine when compared to those in the control group (P < 0.05).

conclusionOlanzapine can enhance CINV induced by MEC regimen in female patients across all age groups, including the elderly, and therefore improve the quality of life for these patients. CLINICAL

trial registrationhttps://www.chictr.org.cn/index.html , identifier: ChiCTR20000368269, 25/08/2020.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsIrinotecanNauseaOlanzapineOxaliplatinVomitingAdultAgedAntiemeticsDexamethasoneFemaleGastrointestinal NeoplasmsHumansMiddle AgedPalonosetronProspective StudiesAntiemeticsDexamethasoneIrinotecanOlanzapineOxaliplatinPalonosetronCINVEntire age bracketFemaleLow-dose olanzapineModerately emetogenic chemotherapy

Identifiers

PMID38806870
PMCPMC11133208

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.