Evidence map›Paper›PMID 39969577›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2025

A group sequential response-adaptive randomized double-blinded clinical trial to evaluate the safety and efficacy of add-on olanzapine plus pregabalin for the prevention of chemotherapy-induced nausea and vomiting.

Mathan Kumar Ramasubbu, Debasish Hota, Saroj Kumar Das Majumdar, Dillip Kumar Parida, Priyanka Mukherjee, Anand Srinivasan

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Olanzapine (10 mg vs 5 mg vs 2.5 mg) for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) - a systematic review and network meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
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

6 authors.

Mathan Kumar RamasubbuDepartment of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
Debasish HotaDepartment of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
Saroj Kumar Das MajumdarDepartment of Radiation Oncology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
Dillip Kumar ParidaDepartment of Radiation Oncology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
Priyanka MukherjeeDepartment of Radiation Oncology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
Anand SrinivasanDepartment of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India. anandsrinivasan@aiimsbhubaneswar.edu.in.

Funding

Indian Council of Medical Research No. 3/2/June- 2021/Pg-Thesis-HRD (01)
6 · The paper itself

Abstract

purposeEven with antiemetic prophylaxis, patients undergoing cancer chemotherapy often still experience chemotherapy-induced nausea and vomiting (CINV). Neurokinin-1 (NK-1) receptor antagonists will prevent CINV effectively but are not affordable for patients of low socioeconomic status.

methodsIn this group sequential, response adaptive randomized double-blinded clinical trial, patients of low socioeconomic who cannot afford NK-1 receptor antagonists, planned for highly emetogenic chemotherapy (HEC) agents received olanzapine 5 mg plus pregabalin 75 mg or placebo orally for five days add-on to standard antiemetic therapy (injection ondansetron 8 mg + injection dexamethasone 12 mg on day one followed by oral dexamethasone 8 mg on days 2 to 4). The primary outcome was the difference in the proportion of patients with "overall no nausea" between groups. Following the interim analysis, the allocation ratio was modified, resulting in more patients being assigned to the well-performing arm.

resultsInitially, 30 patients were equally randomized into two groups. As the experimental group performed well in the interim analysis, the allocation ratio was changed to 2:1 for the subsequent period. Finally, the experimental group (n = 36) performed better in terms of "overall no nausea" than the control group(n = 18) (41.6% vs. 5.5%, p = 0.008). Sedation and dizziness were significantly greater in the experimental group compared to the standard-of-care group.

conclusionOlanzapine 5 mg plus pregabalin 75 mg add-on to a combination of dexamethasone and ondansetron will significantly prevent the incidence of CINV compared to a combination of dexamethasone and ondansetron alone. However, the combination is associated with sedation and dizziness as adverse events.

trial registrationClinical trial registry-India (CTRI/2021/08/035451). Registration Date: 05/08/2021.

Indexed as

AntiemeticsAntineoplastic AgentsNauseaOlanzapinePregabalinVomitingAdultAgedDexamethasoneDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedNeoplasmsAntiemeticsAntineoplastic AgentsDexamethasoneOlanzapineOndansetronPregabalinCINVGroup-sequential designOlanzapinePregabalinResponse adaptive randomizationSubstance P

Identifiers

PMID39969577

What OpenQuestion holds

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Registered trials

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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.