Evidence map›Paper›PMID 35473351›Full record

ArticleJournal of traditional Chinese medicine = Chung i tsa chih ying wen pan2022

An international multicentric phase Ⅲ randomized controlled trial of time-acupoints-space acupuncture for the prevention of chemotherapy-induced fatigue in patients with early stage breast cancer: a study protocol.

Saghachian Mahasti, Barry Caroline, Asselain Bernard, L I Yunfen, Nie Jianyun, Liu Dequan, Chen Dedian, Chen Chunxin, Laura Estevez, L I Wenhui and 3 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
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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

13 authors at 1 institution in 1 country.

Saghachian MahastiInstitute Gustave Roussy, Paris, France.
Barry CarolineResearch Center of Epidemiology and public health, Paris, France.
Asselain BernardInstitute Curie of Paris, Paris, France.
L I YunfenYunnan Cancer Hospital, Third Affiliated Hospital of Kunming Medical University, Kunming, China.
Nie JianyunYunnan Cancer Hospital, Third Affiliated Hospital of Kunming Medical University, Kunming, China.
Liu DequanYunnan Cancer Hospital, Third Affiliated Hospital of Kunming Medical University, Kunming, China.
Chen DedianYunnan Cancer Hospital, Third Affiliated Hospital of Kunming Medical University, Kunming, China.
Chen ChunxinMD Anderson Cancer Hospital, Madrid, Spain.
Laura EstevezMD Anderson Cancer Hospital, Madrid, Spain.
L I WenhuiYunnan Cancer Hospital, Third Affiliated Hospital of Kunming Medical University, Kunming, China.
Jean-Pierre ArmandInstitute Gustave Roussy, Paris, France.
Zhu MianshengARIATAS Association pour la Recherche et l' Information de l' Acupuncture Time-Acupoints-Space, Paris, France.
J U LiyaPreciMed Platform Europe, Paris, France.
Institut Gustave Roussy · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the difference in prevention of chemotherapy-induced fatigue between time-acupoints-space acupuncture (ATAS) administered weekly compared to sham acupuncture and non-acupuncture in patients with early breast cancer receiving adjuvant chemotherapy by epirubicine-cyclophosphamide (EC) followed by paclitaxel, as measured by the multi-dimensional fatigue inventory (MFI) over the previous week and Visual Analogue Scale measuring fatigue (VAS-F), and to evaluate the effects of ATAS on self-reported neuropathy pain, sleep, anxiety and depression.

methodsIn this multicenter clinical trial, we have randomized patients into 3 groups: ATAS, Sham and non-acupuncture with an unequal randomization of 2∶1∶1. A cloud related electronical clinical report form and smartphone platform was established for data entry. Patients with a history of stage Ⅰ-Ⅲ breast cancer scheduled to receive adjuvant chemotherapy. Acupuncture will be delivered once a week during chemotherapy with VAS-F evaluation. In order to qualify and quantify the mechanism of fatigue induced by chemotherapy with or without acupuncture, an evaluation of immune profiling was incorporate in this study.

resultsThe presence and seriousness of chemotherapy-induced fatigue should be considered in therapeutic programs for early breast cancer treatment. Fatigue induced by adjuvant chemotherapy in patients with breast cancer remains a major concern affecting the quality of life significantly. Unfortunately, we do not have effective pharmacological interventions yet. And clinical trials of acupuncture in preventing chemotherapy-induced fatigue in patients with early breast cancer have not been reported.

conclusionThe findings of the trial will allow us to determine the effects of acupuncture treatment approach. We will also be able to confirm whether ATAS is better than sham acupuncture and non-acupuncture treatments.

Indexed as

Acupuncture TherapyAntineoplastic AgentsBreast NeoplasmsAcupuncture PointsClinical Trials, Phase III as TopicFemaleHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicAntineoplastic Agentsbreast neoplasmschemotherapy, adjuvantclinical protocolsfatigueimmunitytime-acupoints-space acupuncture

Identifiers

PMID35473351
PMCPMC9924663
OpenAlexW4224991077

What OpenQuestion holds

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Registered trials

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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.