Evidence map›Paper›PMID 26102212›Full record

ArticleNutrients2015

Pharmacokinetics and Toxicity of Sodium Selenite in the Treatment of Patients with Carcinoma in a Phase I Clinical Trial: The SECAR Study.

Ola Brodin, Staffan Eksborg, Marita Wallenberg, Charlotte Asker-Hagelberg, Erik H Larsen, Dag Mohlkert, Clara Lenneby-Helleday, Hans Jacobsson, Stig Linder, Sougat Misra and 1 more

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Nutrients, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 2 pooled it
9.8field-weighted citation impact, top 1% 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

61 citing papers in PubMed, 2 syntheses or guidelines pooled it, 113 citations in OpenAlex.

  1. Pooled it
  2. Selenium for preventing cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Selenium-Containing Compounds in Breast Cancer Therapy.Biological trace element research · 2026
    Review
  8. Selenium-Based Nanoplatforms: An Emerging Theranostic Paradigm for Gynecological Cancers.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review

1 more citing papers are in PubMed but not listed here.

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

11 authors at 3 institutions in 2 countries.

Ola BrodinDepartment of Oncology, Karolinska Institutet, Karolinska University Hospital Södersjukhuset, SE-118 83 Stockholm, Sweden. ola.brodin@karolinska.se.
Staffan EksborgDepartment of Women's and Children's Health, Karolinska Institutet, Karolinska University Hospital Solna, SE-171 76 Stockholm, Sweden. staffan.eksborg@karolinska.se.
Marita WallenbergDepartment of Laboratory Medicine, Division of Pathology F46, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden. marita.wallenberg@ki.se.
Charlotte Asker-HagelbergMedical Products Agency, P.O. Box 26, SE-751 03 Uppsala, Sweden. charlotte.asker-hagelberg@mpa.se.
Erik H LarsenNational Food Institute, Technical University of Denmark, DK-2860 Søborg, Denmark. ehlar@food.dtu.dk.
Dag MohlkertDepartment of Radiology, Karolinska University Hospital Södersjukhuset, SE-171 76 Stockholm, Sweden. dag.mohlkert@sodersjukhuset.se.
Clara Lenneby-HelledayDepartment of Oncology, Karolinska Institutet, Karolinska University Hospital Södersjukhuset, SE-118 83 Stockholm, Sweden. clara.lenneby-helleday@karolinska.se.
Hans JacobssonDepartment of Radiology, Karolinska University Hospital, Solna, SE-171 76 Stockholm, Sweden. hans.jacobsson@karolinska.se.
Stig LinderDepartment of Oncology-Pathology, Karolinska Institutet, Stockholm SE-171 76, Sweden. Stig.Linder@ki.se.
Sougat MisraDepartment of Laboratory Medicine, Division of Pathology F46, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden. sougat.misra@ki.se.
Mikael BjörnstedtDepartment of Laboratory Medicine, Division of Pathology F46, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden. mikael.bjornstedt@ki.se.
Karolinska University Hospital · SEKarolinska Institutet · SETechnical University of Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSodium selenite at high dose exerts antitumor effects and increases efficacy of cytostatic drugs in multiple preclinical malignancy models. We assessed the safety and efficacy of intravenous administered sodium selenite in cancer patients' refractory to cytostatic drugs in a phase I trial. Patients received first line of chemotherapy following selenite treatment to investigate altered sensitivity to these drugs and preliminary assessment of any clinical benefits. MATERIALS AND

methodsThirty-four patients with different therapy resistant tumors received iv sodium selenite daily for consecutive five days either for two weeks or four weeks. Each cohort consisted of at least three patients who received the same daily dose of selenite throughout the whole treatment. If 0/3 patients had dose-limiting toxicities (DLTs), the study proceeded to the next dose-level. If 2/3 had DLT, the dose was considered too high and if 1/3 had DLT, three more patients were included. Dose-escalation continued until the maximum tolerated dose (MTD) was reached. MTD was defined as the highest dose-level on which 0/3 or 1/6 patients experienced DLT. The primary endpoint was safety, dose-limiting toxic effects and the MTD of sodium selenite. The secondary endpoint was primary response evaluation. RESULTS AND

conclusionMTD was defined as 10.2 mg/m(2), with a calculated median plasma half-life of 18.25 h. The maximum plasma concentration of selenium from a single dose of selenite increased in a nonlinear pattern. The most common adverse events were fatigue, nausea, and cramps in fingers and legs. DLTs were acute, of short duration and reversible. Biomarkers for organ functions indicated no major systemic toxicity. In conclusion, sodium selenite is safe and tolerable when administered up to 10.2 mg/m(2) under current protocol. Further development of the study is underway to determine if prolonged infusions might be a more effective treatment strategy.

Indexed as

Administration, IntravenousAdultAgedAntineoplastic AgentsBiomarkersDose-Response Relationship, DrugDrug Administration ScheduleEndpoint DeterminationFatigueFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNauseaNeoplasmsAntineoplastic AgentsBiomarkersSodium Selenitecarcinomamaximum tolerated dosepharmacokineticssodium selenite

Identifiers

PMID26102212
PMCPMC4488827
OpenAlexW1599108883

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.