Evidence map›Paper›PMID 41282614›Full record

Trial reportFrontiers in pharmacology2025

Prophylactic effect of the traditional Chinese medicine formula

Shuang Yu, Xinrui Hu, Yaqin Tan, Caixia Wang, Zhenyu Shao, Ying Xiao, Hailong Liu, Jing Lv, Sheng Li, Xuan Jiang and 2 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05289726 (Randomized Controlled Clinical Trials to Evaluate the Preventive Effect of Traditional Chinese Medicine TDX105 on Anti-tumor Target Therapy Regorafenib Induced Dermatologic Toxicities), which is not on this map. Not yet cited in PubMed.

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

NCT05289726 phase2unknown statusnot on this map

Randomized Controlled Clinical Trials to Evaluate the Preventive Effect of Traditional Chinese Medicine TDX105 on Anti-tumor Target Therapy Regorafenib Induced Dermatologic Toxicities

TypeinterventionalSponsorCancer Institute and Hospital, Chinese Academy of Medical SciencesRan2022 to 2023Enrolled152ConditionsHand and Foot Skin Reaction, Colorectal Cancer Stage IVArmsTraditional chinese medicine TDX105, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Shuang Yu *National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Xinrui Hu *National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yaqin TanBaotou Cancer Hospital, Baotou, Inner Mongolia, China.
Caixia WangShandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China.
Zhenyu ShaoQilu Hospital of Shandong University, Jinan, Shandong, China.
Ying XiaoThe First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Hailong LiuChenzhou No. 1 People's Hospital, Chenzhou, Hunan, China.
Jing LvThe Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
Sheng LiDepartment of Medical Oncology, The Affiliated Cancer Hospital of Nanjing Medical University and Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research, Nanjing, Jiangsu, China.
Xuan JiangThe Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Lingzhi ZengJiu Jiang No. 1 People's Hospital, Jiujiang, Jiangxi, China.
Aiping TianNational Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Hand-foot skin reaction (HFSR) is the most common side effect of the antineoplastic drug Regorafenib. It severely affects patients' quality of life, and no clear treatment is currently available for the condition. In preliminary clinical studies, the traditional Chinese medicine compound Danxiong Granules (TDX105) has shown significant therapeutic benefit for HFSR. This study aimed to evaluate the prophylactic effect of TDX105 for HFSR. Methods: A total of 137 colorectal cancer patients scheduled for Regorafenib treatment were randomly assigned in a 2:1 ratio to a treatment group (n = 91) and a control group (n = 46), which received basic treatment (topical urea ointment) plus TDX105 or placebo, respectively, for 8 weeks. Follow-up was conducted until tumor regression or Regorafenib discontinuation. The primary study endpoint was the incidence of HFSR within 8 weeks. Results: The total incidence of HFSR was markedly lower in the treatment group than in the control group (76.1% vs. 53.8%), particularly for grade 3 HFSR (7.7% vs. 19.6%, Conclusion: TDX105 significantly reduced the incidence and severity of Regorafenib-induced HFSR. This finding lends support to the use of TDX105 for prevention of HFSR. Clinical trial registration: NCT05289726.

Indexed as

hand-foot skin reactionrandomized controlled clinical trialregorafenibTDX105traditional Chinese medicine formula

Identifiers

PMID41282614
PMCPMC12631313

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Registered trials

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.