Evidence map›Paper›PMID 35297709›Full record

Trial reportIntegrative cancer therapies

Efficacy of Prophylactic Traditional Chinese Medicine on Skin Toxicity of Afatinib in

Chia-Ling Li, Te-Chun Hsia, Su-Tso Yang, Kun-San Clifford Chao, Chih-Yen Tu, Hung-Jen Chen, Chia-Hsiang Li

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

Trial report in Integrative cancer therapies. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05204758 (Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 29% 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.

NCT05204758 phase3completednot on this map

Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect

TypeinterventionalSponsorChina Medical University HospitalRan2016 to 2021Enrolled30ConditionsAdvanced Lung AdenocarcinomaArmsTCM Formula, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. 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

7 authors at 1 institution in 1 country.

Chia-Ling LiGraduate Institute of Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan.
Te-Chun HsiaDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Su-Tso YangSchool of Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan.ORCID 0000-0002-7977-1275
Kun-San Clifford ChaoCancer Center, China Medical University Hospital, Taichung, Taiwan.
Chih-Yen TuDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Hung-Jen ChenDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.ORCID 0000-0001-6000-9021
Chia-Hsiang LiDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
China Medical University · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy of prophylactic traditional Chinese medicine (TCM) on skin toxicities in patients with advanced lung adenocarcinoma treated with first-line epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) in a randomized-controlled trial (RCT). MATERIALS AND

methodsThis pilot study was a prospective, single-center, double-blinded RCT. The study enrolled patients with a new diagnosis of locally advanced and metastatic lung adenocarcinoma harboring

resultsThere were 36 patients with newly diagnosed lung adenocarcinoma during the study period. After the exclusion of 6 patients, the remaining 30 patients were assigned to the TCM (n = 14) and placebo (n = 16) groups comprising the intention-to-treat population. The time to first skin toxicity was 22.3 days in the TCM group and 17.6 days in the placebo group (P = .510) in the per-protocol population. The analysis of the present pilot study results determined that the difference in time to first skin toxicity between the 2 groups would reach statistical significance with a sample size of 237 based on a power of 0.8. There were significant differences in certain subscales of quality of life between the TCM and placebo groups; however, there was no significant difference in progression-free survival or overall survival between the 2 groups.

conclusionsIntegrative TCM may prolong the time to first skin toxicity in patients with advanced lung adenocarcinoma treated with first-line afatinib. Prophylactic TCM could delay skin toxicity of any grade and reduce the incidence of grade 3 skin toxicity. Future large-scale RCTs are warranted to validate these findings.

trial registrationClinicalTrials.gov, NCT05204758. Registered on 24 Jan 2022.

Indexed as

Adenocarcinoma of LungCarcinoma, Non-Small-Cell LungLung NeoplasmsAfatinibErbB ReceptorsHumansMedicine, Chinese TraditionalMutationPilot ProjectsProtein Kinase InhibitorsAfatinibEGFR protein, humanErbB ReceptorsProtein Kinase Inhibitorsadvanced lung adenocarcinomaEGFR-TKIprophylaxisquality of lifeskin toxicitytraditional Chinese medicine

Identifiers

PMID35297709
PMCPMC8943309
OpenAlexW4220980532

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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.