Evidence map›Paper›PMID 32503654›Full record

ArticleTrials2020

Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial.

Yan Wang, Ming-Xi Jing, Lei Jiang, Yu-Feng Jia, E Ying, Hui Cao, Xiang-Yu Guo, Tao Sun

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

15 citing papers in PubMed, 19 citations in OpenAlex.

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  15. Microbiota-Host-Irinotecan Axis: A New Insight Toward Irinotecan Chemotherapy.Frontiers in cellular and infection microbiology · 2021
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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 1 institution in 1 country.

Yan WangDepartment of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.
Ming-Xi JingDepartment of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.
Lei JiangDepartment of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.
Yu-Feng JiaDepartment of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.
E YingDepartment of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.
Hui CaoDepartment of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.
Xiang-Yu GuoDepartment of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.
Tao SunDepartment of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China. jianong@126.com.ORCID http://orcid.org/0000-0001-5931-386X
Liaoning Cancer Hospital & Institute · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent studies have indicated that a ketogenic diet can be used as an adjuvant therapy to enhance sensitivity to chemotherapy and radiotherapy in cancer patients. However, there are no sufficient data and no consistent international treatment guidelines supporting a ketogenic diet as an adjuvant therapy for metastatic breast cancer. Therefore, this trial was designed to observe whether irinotecan with a ketogenic diet can promote sensitivity to chemotherapy and remit target lesions in locally recurrent or metastatic Her-2-negative breast cancer patients. METHODS/

designThis trial aims to recruit 518 women with locally recurrent or metastatic breast cancer admitted to the Liaoning Cancer Hospital and Institute (Shenyang, China) in northeast China. All patients will be randomly assigned into the combined intervention group (n = 259) or the control group (n = 259), followed by treatment with irinotecan + ketogenic diet or irinotecan + normal diet, respectively. The primary endpoints are sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness. The endpoints will be evaluated at baseline (before drug administration), during treatment, 4 weeks after treatment completion, and every 3months (beginning 2 months after treatment completion). DISCUSSION: This trial attempts to investigate whether irinotecan treatment with a ketogenic diet for locally recurrent or metastatic breast cancer among women in northeast China can enhance the disease's sensitivity to chemotherapy and reduce target lesions.

trial registrationChinese Clinical Trial Registry, ID: ChiCTR1900024597. Registered on 18 July 2019. Protocol Version: 1.1, 24 February 2017.

Indexed as

ChinaCombined Modality TherapyCost-Benefit AnalysisDiet, KetogenicDisease-Free SurvivalFemaleHumansInduction ChemotherapyIrinotecanNeoplasm MetastasisNeoplasm Recurrence, LocalProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeTriple Negative Breast NeoplasmsIrinotecanBreast cancerClinical trialIrinotecan, Chemotherapy sensitivityKetogenic dietObjective response rateRandomized controlled trial

Identifiers

PMID32503654
PMCPMC7275564
OpenAlexW3032918972

What OpenQuestion holds

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LicenceCC BY
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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.