Evidence mapPaperPMID 39469996Full record

ArticleIntegrative cancer therapies

Safety of the Herbal Medicine SH003 in Patients With Solid Cancer: A Multi-Center, Single-Arm, Open-Label, Dose-Escalation Phase I Study.

Chunhoo Cheon, Hyun Woo Lee, Sun Jin Sym, Seong-Gyu Ko

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Integrative cancer therapies. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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

5 citing papers in PubMed.

  1. Review
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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

4 authors.

Chunhoo CheonKyung Hee University, Dongdaemun-gu, Seoul, Republic of Korea.ORCID 0000-0002-7078-0079
Hyun Woo LeeAjou University Hospital, Suwon-si, Gyeonggi-do, Republic of Korea.
Sun Jin SymGachon University Gil Medical Center, Namdong-gu, Incheon, Republic of Korea.
Seong-Gyu KoKyung Hee University, Dongdaemun-gu, Seoul, Republic of Korea.ORCID 0000-0002-2345-430X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSH003, a novel herbal medicine comprising Huang-Qi, Dang-Gui, and Gua-Lou-Gen, has historical roots in traditional medicine with reported anticancer properties. The need to explore safe and effective treatments in oncology underlines the importance of this study.

methodsThis phase I trial, conducted at Ajou University Hospital and Gachon University Gil Medical Center in Korea, adopted a single-arm, open-label, dose-escalation design. It aimed to evaluate the safety of escalated doses of SH003 in patients with various solid cancers, focusing on determining its maximum tolerated dose. Participants with confirmed solid cancers, unresponsive to standard treatments, were enrolled. The dosage of SH003 was escalated from 4800 to 9600 mg per day, using a 3 + 3 design. Safety was assessed based on the Common Terminology Criteria for Adverse Events ver. 5.0.

resultsThe study established that the maximum tolerated dose of SH003 is 9600 mg/day. Most adverse events were mild, primarily including dizziness and nausea, indicating the tolerability of SH003 at this dosage.

conclusionsSH003 demonstrates safety and promises as an anticancer treatment at doses up to 9600 mg/day. This research supports further investigation into its efficacy for cancer therapy, emphasizing the significance of natural products in oncology, particularly concerning patient safety and tolerance.

Indexed as

Drugs, Chinese HerbalMaximum Tolerated DoseNeoplasmsAdultAgedAngelicaAstragalus PlantDose-Response Relationship, DrugFemaleHerbal MedicineHumansMaleMiddle AgedPlant ExtractsRepublic of KoreaTrichosanthesDrugs, Chinese HerbalPlant ExtractsSH003 extractcancerherbal medicinemaximum tolerated dosenatural productphase I trialsafetySH003

Identifiers

PMID39469996
PMCPMC11528795

What Socratic 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 Socratic graph.