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NCT03959618: CIVCAP

Intravenous Chemotherapy and Plant-based Dietary Supplements

Completed Last updated 21 May 2021
What this trial tests

trial testing dietary supplements questionary in Breast Cancer in 200 participants. Completed in 13 May 2020.

Timeline
2 April 2019
Primary endpoint
13 May 2020
13 May 2020

Quick facts

Lead sponsorInstitut Cancerologie de l'Ouest
StatusCompleted
Study typeOBSERVATIONAL
Enrollment200
Start date2 April 2019
Primary completion13 May 2020
Estimated completion13 May 2020
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Institut Cancerologie de l'Ouest — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

More and more patients report taking dietary supplements based on herbal medicine, aromatherapy, vitamintherapy,... in the course of their detoxifying anticancer chemotherapy, to stimulate the immune defenses, to relieve and/or decrease the side effects of chemo or even to act against cancer. At European level, there are between 15 and 73% of patients treated for cancer taking a dietary supplement (in particular phytotherapy) or a great heterogeneity according to the studies. However, there is still little evidence of the efficacy of these dietary supplements. A large proportion of patients do not seem to inform their doctor about the use of dietary supplements. Patients using dietary supplements most often ignore the mode of action of these products and generally say they are not informed. In 2015, at the West Cancerology Institute (ICO), 5 patient files were analyzed taking this type of treatment in addition to chemotherapy; in 2016, 24 files; 2017, 61 patient records and this continues to progress. At the same time, a product appears very frequently associated with cancer chemotherapy: Desmodium Adscendens, an African plant with in vitro properties of liver protector. The Desmodium contains triterpene saponins, alkaloids, flavonoids, polyphenols, and tryptamine derivatives. Morevover, several situations of patients undergoing chemotherapy and taking long-term Desmodium, with hepatic cytolyses were experienced, not explained by the usual treatments (case described in the literature). Therefore, this study will evaluate these new therapeutic modalities that are included in the intake of chemotherapy in order to better know them to improve the therapeutic taking of patients and to focus on the impact of Desmodium in association with chemotherapy.

Publications & conference data

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

  1. Dietary factors and their influence on immunotherapy strategies in oncology: a comprehensive review.
    Golonko A, Pienkowski T, Swislocka R, Orzechowska S, et al · · 2024 · cited 39× · PMID 38594256 · DOI 10.1038/s41419-024-06641-6
  2. Advances in Diet and Physical Activity in Breast Cancer Prevention and Treatment.
    Khalifa A, Guijarro A, Nencioni A. · · 2024 · cited 17× · PMID 39064705 · DOI 10.3390/nu16142262
  3. Flavonoid-Based Combination Therapies and Nano-Formulations: An Emerging Frontier in Breast Cancer Treatment.
    Uniyal P, Akhtar A, Rawat R. · · 2025 · cited 2× · PMID 41155601 · DOI 10.3390/ph18101486

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Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03959618.

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