Evidence mapPaperPMID 40105683Full record

Trial reportActa oncologica (Stockholm, Sweden)2025

Tolerability, safety and feasibility of metformin combined with chemoradiotherapy in patients with locally advanced cervical cancer: A phase II, randomized study.

Kjersti Skipar, Tord Hompland, Kjersti V Lund, Christina S Fjeldbo, Kristina Lindemann, Taran P Hellebust, Heidi Lyng, Kjersti Bruheim

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Acta oncologica (Stockholm, Sweden), 2025. 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. Article
  2. Review
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.

Kjersti SkiparDepartment of Oncology, Telemark Hospital Trust, Skien, Norway; Department of Radiation Biology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway. kjeski@sthf.no.
Tord HomplandDepartment of Radiation Biology, Oslo University Hospital, Oslo, Norway.
Kjersti V LundDepartment of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.
Christina S FjeldboDepartment of Radiation Biology, Oslo University Hospital, Oslo, Norway.
Kristina LindemannDepartment of Surgical Oncology, Section for gynecological oncology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Taran P HellebustDepartment of Medical Physics, Oslo University Hospital, Oslo, Norway.
Heidi LyngDepartment of Radiation Biology, Oslo University Hospital, Oslo, Norway; Department of Physics, University of Oslo, Oslo, Norway.
Kjersti BruheimDepartment of Oncology, Oslo University Hospital, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeLocally advanced cervical cancer is treated with chemoradiotherapy. The treatment-related morbidity is high. Tumor hypoxia has prognostic impact and represents a valid, interventional target. This phase II study investigated efficacy of the antidiabetic drug metformin to modify hypoxia according to established biomarkers. Preliminary results including tolerability, safety and feasibility are reported here. PATIENTS AND

methodsPatients were included in a 1:1 randomized, open-label design, comparing standard chemoradiotherapy ± metformin. Metformin 850 mg twice daily was administered 1 week before and during chemoradiotherapy. Magnetic resonance images (MRI) and tumor biopsies were collected at baseline, after 1 week of metformin treatment, and at brachytherapy for biomarker assessments. Tolerability and safety were determined by treatment completion rates and frequency of adverse events (AEs). Safety was further evaluated by possible increase in MRI-based hypoxia during the first week of metformin. Feasibility was determined by proportion of completed study interventions and imaging and biopsy procedures.

resultsIn total, 18 and 23 patients were allocated to the intervention and control arm, respectively. Eighteen and 15 patients completed metformin treatment for 1 and 5 weeks. Frequency of AEs ≥ grade 3 was not significantly different between study arms. Most AEs were gastrointestinal toxicities. Tumors with increase in hypoxia during the first week were all below the defined safety limit. A total of 98% of scheduled MR series and biopsies were collected with satisfactory quality.

interpretationAddition of metformin to chemoradiotherapy is tolerable and safe. Serial sampling of MRI and tumor biopsies for hypoxia biomarker assessment is feasible.

Indexed as

ChemoradiotherapyHypoglycemic AgentsMetforminUterine Cervical NeoplasmsAdultAgedFeasibility StudiesFemaleHumansMagnetic Resonance ImagingMiddle AgedTumor HypoxiaHypoglycemic AgentsMetformin

Identifiers

PMID40105683
PMCPMC11971942

What Socratic 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 Socratic graph.