Evidence map›Paper›PMID 34910380›Full record

Trial reportCancer reports (Hoboken, N.J.)2022

Validation of the prophylactic efficacy of urea-based creams on sorafenib-induced hand-foot skin reaction in patients with advanced hepatocellular carcinoma: A randomised experiment study.

Ru-Yu Lien, Heng-Hsin Tung, Shang-Laing Wu, Sophia H Hu, Ling-Chun Lu, Shu-Fen Lu

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer reports (Hoboken, N.J.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04568330 (Re-validating Prophylactic Efficacy of Urea-based Cream on Sorafenib-induced Hand-foot Skin Reaction in Patients With Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% 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.

NCT04568330 nacompletednot on this map

Re-validating Prophylactic Efficacy of Urea-based Cream on Sorafenib-induced Hand-foot Skin Reaction in Patients With Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorTaipei Veterans General Hospital, TaiwanRan2014 to 2015Enrolled129ConditionsHepatocellular CarcinomaArmsbest support care, moisture cream, 10% urea-based cream
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Efficacy of hydrocolloid dressing for hand-foot skin reaction: J-SUPPORT 1701 APRON trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
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

6 authors at 4 institutions in 2 countries.

Ru-Yu LienDepartment of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.
Heng-Hsin TungDepartment of Nursing, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Shang-Laing WuBiostatistical Consultant, School of Medicine, Griffith University, Gold Coast, Australia.
Sophia H HuDepartment of Nursing, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Ling-Chun LuSecond Degree of Science in Nursing, College of Medicine, National Taiwan University, Taipei, Taiwan.ORCID 0000-0003-3785-3659
Shu-Fen LuDepartment of Nursing, National Yang Ming Chiao Tung University, Taipei, Taiwan.
National Yang Ming Chiao Tung University · TWGriffith University · AUNational Taiwan University · TWTaipei Veterans General Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHand-foot skin reaction may influence the effectiveness of patients' treatment, patient quality of life, and the economics of health care. An effective prophylactic dermatological cream for preventing sorafenib-induced hand-foot skin reaction (HFSR) is yet to be identified.

aimThe aim of this study is validated the prophylactic efficacy of urea-based creams on sorafenib-induced hand-foot skin reaction in patients with advanced hepatocellular carcinoma.

methodsThis was a randomised double-blind experimental study. A total of 129 patients with advanced HCC were randomly assigned to three groups. The comparison group received best supportive care (BSC), group A received BSC plus a moisturising cream, and group B received BSC plus a 10% urea-based cream. Incidence of HFSR and cutaneous wetness were assessed 3 days before starting sorafenib and each week after starting sorafenib for 8 weeks.

resultsNo significant difference was observed in the incidence density of sorafenib-induced HFSK (comparison group/A group, p > .05; comparison group/B group, p > .05). Group B reported significantly better cutaneous wetness of hands in the seventh week after starting sorafenib (p < .05) and of feet during the first 6 weeks (p < .05-.001).

conclusionThis study found a nut size amount of a 10% urea-based cream applied twice a day can maintain patients' cutaneous wetness in the first 6 weeks after starting sorafenib than moisturising-alone cream. But it cannot reduce the occurrence of HFSR. Thus, the result supports nut-size dose of the 10% urea-based cream three times a day may be an appropriate dose to prevent HFSR. Clinical Trail Registration Number: NCT04568330.

Indexed as

Antineoplastic AgentsCarcinoma, HepatocellularHand-Foot SyndromeLiver NeoplasmsHumansNiacinamidePhenylurea CompoundsQuality of LifeSorafenibUreaAntineoplastic AgentsNiacinamidePhenylurea CompoundsSorafenibUreahead-foot skin reactionhepatocellular carcinomaside effect of Sorafenibsymptom management

Identifiers

PMID34910380
PMCPMC9327657
OpenAlexW4200564012

What OpenQuestion holds

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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.