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NCT04275713: METOXY-LACC

Altered Tumor Oxygenation by Metformin, a Potential Step in Overcoming Radiotherapy Resistance in LACC

Completed Phase 2 Last updated 20 January 2025
What this trial tests

Phase 2 trial testing Metformin in Cervical Cancer in 41 participants. Completed in 8 November 2024.

Timeline
22 May 2020
Primary endpoint
11 June 2024
8 November 2024

Quick facts

Lead sponsorOslo University Hospital
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment41
Start date22 May 2020
Primary completion11 June 2024
Estimated completion8 November 2024
Sites1 location across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Oslo University Hospital

Who can join

18 and older, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Poor tumor oxygenation (hypoxia) is an established negative prognostic and predictive factor in locally advanced cervical cancer (LACC). Hypoxia-modifying measures implemented in the clinic are lacking. Metformin is a well-known, well-tolerated and low-cost drug used for decades in the treatment of type 2- diabetes. Recent studies suggest an improved tumor oxygenation by metformin potentially improving radiotherapy response and patient outcome. This study is a randomized, phase II, open label study in patients with LACC where patients are randomized to standard cisplatin-based chemoradiotherapy +/- Metformin. Metformin will be started one week prior to the start of chemoradiotherapy, and will be continued throughout the entire radiation treatment. Tumor oxygenation will be evaluated by gene signatures and MRI- parameters.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tumor Hypoxia Regulates Immune Escape/Invasion: Influence on Angiogenesis and Potential Impact of Hypoxic Biomarkers on Cancer Therapies.
    Abou Khouzam R, Brodaczewska K, Filipiak A, Zeinelabdin NA, et al · · 2020 · cited 135× · PMID 33552076 · DOI 10.3389/fimmu.2020.613114
  2. Tumor hypoxia: From basic knowledge to therapeutic implications.
    Liao C, Liu X, Zhang C, Zhang Q. · · 2023 · cited 123× · PMID 36603793 · DOI 10.1016/j.semcancer.2022.12.011
  3. Interfering with Tumor Hypoxia for Radiotherapy Optimization.
    Telarovic I, Wenger RH, Pruschy M. · · 2021 · cited 119× · PMID 34154610 · DOI 10.1186/s13046-021-02000-x
  4. Metabolic requirements of pulmonary fibrosis: role of fibroblast metabolism.
    Hamanaka RB, Mutlu GM. · · 2021 · cited 69× · PMID 33393204 · DOI 10.1111/febs.15693
  5. Perspectives on Hypoxia Signaling in Tumor Stroma.
    Zhang Y, Coleman M, Brekken RA. · · 2021 · cited 28× · PMID 34202979 · DOI 10.3390/cancers13123070
  6. Molecular and Cellular Mechanisms of Metformin in Cervical Cancer.
    Chen YH, Wang PH, Chen PN, Yang SF, et al · · 2021 · cited 26× · PMID 34067321 · DOI 10.3390/cancers13112545
  7. Mitochondrial Metabolism: A New Dimension of Personalized Oncology.
    Behnam B, Taghizadeh-Hesary F. · · 2023 · cited 25× · PMID 37627086 · DOI 10.3390/cancers15164058
  8. Combining imaging- and gene-based hypoxia biomarkers in cervical cancer improves prediction of chemoradiotherapy failure independent of intratumour heterogeneity.
    Fjeldbo CS, Hompland T, Hillestad T, Aarnes EK, et al · · 2020 · cited 22× · PMID 32580139 · DOI 10.1016/j.ebiom.2020.102841

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

Other recruiting trials for Cervical Cancer

Currently open trials in the same condition.

Other Oslo University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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