Evidence map›Paper›PMID 37752516›Full record

Trial reportBMC complementary medicine and therapies2023

The effects of synbiotics supplementation on reducing chemotherapy-induced side effects in women with breast cancer: a randomized placebo-controlled double-blind clinical trial.

Yasaman Khazaei, Ali Basi, Maria Luz Fernandez, Hossein Foudazi, Rafat Bagherzadeh, Farzad Shidfar

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

Trial report in BMC complementary medicine and therapies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06560385 (A Pilot, Double-blind, Randomised, Placebo-controlled Trial on the Efficacy of a Synbiotic Formula), which is not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
9.3field-weighted citation impact, top 2% 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.

NCT06560385 narecruitingnot on this mapstarted 2024, after this paper: background citation

A Pilot, Double-blind, Randomised, Placebo-controlled Trial on the Efficacy of a Synbiotic Formula (BLHK03) in Alleviating Chemotherapy-induced Alopecia (CIA) in Breast Cancer Patients

TypeinterventionalSponsorGenieBiome LimitedRan2024 to 2026Enrolled40ConditionsBreast Cancer, Hair LossArmsBLHK03, Active placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 36 citations in OpenAlex.

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  4. The association between the gut microbiome and fatigue in individuals living with cancer: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Pooled it
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  12. ISME communications · 2026
    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

6 authors at 2 institutions in 2 countries.

Yasaman KhazaeiDepartment of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, 1449614535, Iran.
Ali BasiDepartment of Hematology Oncology, Iran University of Medical Sciences, Tehran, Iran.
Maria Luz FernandezDepartment of Nutritional Sciences, University of Connecticut, Storrs, CT, USA.
Hossein FoudaziDepartment of Radiation and Oncology, Shahid Fayaz-Bakhsh Hospital, Tehran, Iran.
Rafat BagherzadehEnglish Department, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.
Farzad ShidfarDepartment of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, 1449614535, Iran. shidfar.f@iums.ac.ir.
Iran University of Medical Sciences · IRUniversity of Connecticut · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prevalence of breast cancer and its mortality rate are increasing rapidly among women worldwide. On other hand, the courses of chemotherapy as the main treatment for these patients are too much exhaustive and annoying. This study was designed to evaluate the use of synbiotics (probiotics + prebiotics) supplementation as a safe and inexpensive adjuvant treatment in reducing common chemotherapy side effects in women with breast cancer.

methodsThe current study was conducted on 67 women with definitive diagnosis of breast cancer who were hospitalized to receive one-day chemotherapy sessions, and met the inclusion criteria. The patients were randomly allocated to the intervention or control group to receive synbiotics or placebo, respectively. They received oral consumption of synbiotics supplements twice a day for 8 weeks. The primary outcome was the changes in severity or experience of chemotherapy complication, analyzed by intention to treat (ITT). The instruments included 7 validated questionnaires which were used to assess chemotherapy complications in the initiation, 4 weeks and 8 weeks after intervention. Dietary intake was measured by 24-h dietary recall at the beginning, week 4 and week 8. Data were analyzed by SPSS software version 24. P-value < 0.05 was considered as statistically significant.

results67 breast cancer patients participated in the study. 8 weeks after intervention and adjusting the confounders, the severity of chemotherapy complications including unnormal defecation (P = 0.005) and fatigue (P < 0/001) decreased significantly in the synbiotics group compared to the placebo group. Furthermore, nausea/vomiting (P = 0.015), and anorexia (P < 0.001) were decreased at the end of the study compared to the first visit, but it was not statistically significant compared to the placebo group.

conclusionsSynbiotics supplementation during chemotherapy can potentially reduce the severity of fatigue and abnormal defecation. It can help reduce anorexia and nausea/vomiting.

trial registrationThis study was registered in the Iranian Registry of Clinical Trials (IRCT) (registered code: IRCT20091114002709N56) (date of registration: 5/5/2021). Direct link to the trial page: https://www.irct.ir/trial/54559 .

Indexed as

Antineoplastic AgentsBreast NeoplasmsSynbioticsAnorexiaFemaleHumansIranAntineoplastic AgentsBreast CancerChemotherapy-induced side EffectsSynbiotcs

Identifiers

PMID37752516
PMCPMC10521476
OpenAlexW4387054014

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.