Evidence map›Paper›PMID 39626189›Full record

Trial reportPancreas2025

Phase II Randomized Controlled Trial to Evaluate the Supportive Effect of Koujin (TJ-3020) Powder in Gemcitabine and Nab-Paclitaxel-Treated Unresectable or Recurrent Pancreatic Cancer.

Tomohisa Otsu, Hideki Takami, Suguru Yamada, Masahiro Nakatochi, Keizo Fujita, Mitsuru Tashiro, Masamichi Hayashi, Nobuhiko Nakagawa, Keisuke Kurimoto, Haruyoshi Tanaka and 3 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Pancreas, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Herbal and pharmacological treatments in cancer-related fatigue.Translational gastroenterology and hepatology · 2026
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Tomohisa OtsuDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine.
Hideki TakamiDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine.ORCID 0009-0004-3294-0168
Suguru YamadaDepartment of Surgery, Nagoya Central Hospital.
Masahiro Nakatochi
Keizo FujitaDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine.
Mitsuru TashiroDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine.
Masamichi HayashiDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine.
Nobuhiko NakagawaDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine.
Keisuke KurimotoDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine.
Haruyoshi TanakaDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine.
Fumie KinoshitaDepartment of Advanced Medicine, Nagoya University Hospital.
Yachiyo KuwatsukaDepartment of Advanced Medicine, Nagoya University Hospital.
Yasuhiro KoderaDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesGemcitabine and nab-paclitaxel combination therapy (GnP) is a standard treatment for unresectable or recurrent pancreatic cancer. However, fatigue and malaise are frequent adverse effects. Recently, Kampo medicine containing ginsenoside has been reported to relieve cancer-related fatigue. Therefore, in this randomized trial, we used red ginseng powder (Koujin, TJ-3020), which contains ginsenoside, to evaluate its effect on unresectable or recurrent pancreatic cancer treatment. MATERIALS AND

methodsFrom December 2017 to December 2020, we enrolled 40 pancreatic cancer patients. The patients underwent 2 cycles of GnP for unresectable cancer or postoperative recurrence. The patients were randomized into group A (red ginseng powder administration) or group B (no red ginseng). In group A, 0.67 g of red ginseng powder was taken orally 3 times a day before each meal for 56 days of the planned chemotherapy period. The Cancer Fatigue Scale evaluated physical, mental, cognitive, and comprehensive fatigue over time.

resultsThe patients' backgrounds, including age, sex, pancreatic cancer status, and relative dose intensity of the GnP chemotherapy, did not differ between groups A and B. Cases with abnormal CA19-9 were frequently assigned to group A. None of the Cancer Fatigue Scale fatigue scores differed significantly between the groups. Mental fatigue score was significantly higher in patients aged ≥70 years (odds ratio: 4.57; P  = 0.033), and recurrent pancreatic cancer status tended to influence all fatigue scores. However, no other critical factor significantly affected each score.

conclusionsIn this phase II randomized trial, oral administration of red ginseng powder at 2.0 g per day did not reduce pancreatic cancer patients' fatigue or malaise induced by GnP combination chemotherapy.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoplasm Recurrence, LocalPanaxPancreatic NeoplasmsAgedAlbuminsDeoxycytidineFatigueFemaleGemcitabineHumansMaleMiddle AgedPaclitaxelPowdersTreatment Outcome130-nm albumin-bound paclitaxelAlbuminsDeoxycytidineGemcitabinePaclitaxelPowderscancer-related fatigueginsengKampopancreatic cancer

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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.