Evidence map›Paper›PMID 32406009›Full record

Trial reportIndian journal of gastroenterology : official journal of the Indian Society of Gastroenterology2020

The effect of TJ-28 (Eppikajutsuto) on the prevention of hand-foot syndrome using Capecitabine for colorectal cancer: The Yokohama Clinical Oncology Group Study (YCOG1102).

Kazuteru Watanabe, Atsushi Ishibe, Jun Watanabe, Mitsuyoshi Ota, Shoichi Fujii, Yasushi Ichikawa, Mari S Oba, Itaru Endo

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 23% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Prophylactic strategies for hand-foot syndrome/skin reaction associated with systemic cancer treatment: a meta-analysis of randomized controlled trials.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Editorial commentary on the Indian Journal of Gastroenterology March-April 2020 issue.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2020
    Article
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

8 authors at 2 institutions in 1 country.

Kazuteru WatanabeDepartment of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.
Atsushi IshibeDepartment of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan. a.ishibe1225@gmail.com.
Jun WatanabeDepartment of Gastroenterological Center, Yokohama City University Medical center, Yokohama, Japan.
Mitsuyoshi OtaDepartment of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.
Shoichi FujiiDepartment of Surgery, Koga Hospital, Shizuoka, Japan.
Yasushi IchikawaDepartment of Oncology, Yokohama City University , Yokohama, Japan.
Mari S ObaDepartment of Biostatics, Yokohama City University , Yokohama, Japan.
Itaru EndoDepartment of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.
Yokohama City University · JPKoga Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEppikajututo (TJ-28, a Kampo medicine) is effective against rheumatoid arthritis and eczema. We conducted a randomized comparative trial to assess the efficacy of TJ-28 for preventing hand-foot syndrome (HFS) as a complication of adjuvant chemotherapy using capecitabine.

methodsThe present study was a multi-institutional randomized-controlled trial (UMIN000005899). Colorectal cancer patients scheduled to receive capecitabine chemotherapy as adjuvant therapy were randomly assigned to receive TJ-28 (7500 mg/day) or oral pyridoxine (60 mg/day). Patients were monitored for the development of grade ≥ 2 HFS according to the National Cancer Institute Common Toxicity Criteria until chemotherapy completion.

resultsTwenty-two patients were enrolled in this study. The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group. Grade ≥ 2 HFS developed in 6 (50.0%) of 12 TJ-28 patients and in 4 (40.0%) of 10 pyridoxine patients. Chemotherapy treatment failure was observed in seven patients, mainly due to HFS, liver dysfunction, diarrhea, and neutropenia. Chemotherapy treatment failure due to HFS occurred in none of the TJ-28 group and 2 patients (20.0%) in the pyridoxine group (p = 0.114).

conclusionCapecitabine-associated HFS was not markedly prevented by TJ-28 compared with pyridoxine. However, TJ-28 might support the continuation of chemotherapy with capecitabine. Further studies are warranted to clarify the benefits of TJ-28.

Indexed as

Negative ResultsPhytotherapyAdultAgedAged, 80 and overCapecitabineChemotherapy, AdjuvantColorectal NeoplasmsDrug Therapy, CombinationFemaleHand-Foot SyndromeHumansMaleMiddle AgedPharmaceutical PreparationsPlant ExtractsCapecitabineeppikajutsutoPharmaceutical PreparationsPlant ExtractsPyridoxineCapecitabineColorectal cancerHand-foot syndromeKampo medicine

Identifiers

PMID32406009
OpenAlexW3024831736

What OpenQuestion holds

Textmetadata
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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.