Evidence map›Paper›PMID 24121454›Full record

Trial reportCancer chemotherapy and pharmacology2013

Goshajinkigan oxaliplatin neurotoxicity evaluation (GONE): a phase 2, multicenter, randomized, double‑blind, placebo‑controlled trial of goshajinkigan to prevent oxaliplatin‑induced neuropathy.

Toru Kono, Taishi Hata, Satoshi Morita, Yoshinori Munemoto, Takanori Matsui, Hiroshi Kojima, Hiroyoshi Takemoto, Mutsumi Fukunaga, Naoki Nagata, Mitsuo Shimada and 2 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 10 pooled it
4.5field-weighted citation impact, top 4% of its field
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

65 citing papers in PubMed, 10 syntheses or guidelines pooled it, 106 citations in OpenAlex.

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  6. Goshajinkigan for prevention of chemotherapy-induced peripheral neuropathy: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
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5 more citing papers are in PubMed but not listed here.

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

12 authors at 9 institutions in 1 country.

Toru Kono
Taishi Hata
Satoshi Morita
Yoshinori Munemoto
Takanori Matsui
Hiroshi Kojima
Hiroyoshi Takemoto
Mutsumi Fukunaga
Naoki Nagata
Mitsuo Shimada
Junichi Sakamoto
Hideyuki Mishima
Aichi Cancer Center · JPSakai Municipal Hospital · JPAichi Medical University · JPFukui-ken Saiseikai Hospital · JPOsaka University · JPSapporo Higashi Tokushukai Hospital · JPTokai Central Hospital · JPTokushima University · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOxaliplatin-induced peripheral neurotoxicity (OPN) is frequent and potentially severe, but successful treatment of this condition is still an unmet clinical need. We aimed to determine whether treatment with goshajinkigan (TJ-107), a traditional Japanese medicine, is better than placebo in preventing OPN in patients with advanced or recurrent colorectal cancer patients treated with standard FOLFOX regimens.

methodsIn this phase 2, randomized, double-blind, placebo-controlled study, patients undergoing oxaliplatin-based chemotherapy were randomized to receive either oral TJ-107 (7.5 g) or matching placebo daily. The severity of OPN was assessed according to the Common Toxicity Criteria for Adverse Events at baseline, every 2 weeks until the 8th cycle, and every 4 weeks thereafter until the 26th week. The primary endpoint was the incidence of grade 2 or greater OPN until the 8th cycle of chemotherapy.

resultsAnalyses were done by intention to treat. Eighty-nine patients were randomly assigned to receive either TJ-107 (n = 44) or placebo (n = 45) between May 2009 and March 2010. The incidence of grade 2 or greater OPN until the 8th cycle was 39 and 51 % in the TJ-107 and placebo groups, respectively (relative risk (RR), 0.76; 95 % CI, 0.47–1.21). The incidence of grade 3 OPN was 7 % (TJ-107) vs. 13 % (placebo) (0.51, 0.14–1.92). No concerns regarding toxicity emerged with TJ-107 treatment.

conclusionsTJ-107 appears to have an acceptable safety margin and a promising effect in delaying the onset of grade 2 or greater OPN without impairing FOLFOX efficacy.

Indexed as

Administration, OralAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDouble-Blind MethodDrugs, Chinese HerbalFemaleFluorouracilHumansIncidenceLeucovorinMaleMiddle AgedNeoplasm Recurrence, LocalDrugs, Chinese HerbalFluorouracilgosha-jinki-ganLeucovorinOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID24121454
PMCPMC3834178
OpenAlexW2095545130

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.