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NCT Number: NCT03959618

Intravenous Chemotherapy and Plant-based Dietary Supplements

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

About this study

  • Determine the quantitative impact of the use of dietary supplements by patients with breast cancer and treated in a neo-adjuvant and/or adjuvant condition by IV chemotherapy in day hospital.
  • Determine an over-risk of disruption of liver balance in the population of patients taking Desmodium.
  • Gather a critical mass of relevant information with the objective of carrying out the evaluation and analysis of cancer care practices related to the intake of dietary supplements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • breast cancer treated by intra-venous chemotherapy
  • inclusion at the last cycle (cure)
  • all chemotherapy cycles realised at ICO

Exclusion criteria

  • no breast cancer
  • metastatic breast cancer
  • not all chemotherapy cycles realised at ICO
  • patient who has not finished his chemotherapy

Treatment and study plan

dietary supplements questionary

Other

Patient Questionary Patient to be carried out at the last cure

Primary outcomes

  1. evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy

    Time frame: 12 months

    rate of patients taking a dietary supplement

Secondary outcomes

  1. Evaluate the impact of taking Desmodium between the first and last cycle of treatment

    Time frame: 12 months

    % of patients with hepatic cytolysis undergoing chemotherapy between the first and last treatments

  2. Description of dietary supplements taken

    Time frame: 12 months

    Description of different types of dietary supplements

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

Mono-centric, Prospective, Non-Interventional Study of Quantitative and Qualitative Analysis of Dietary Supplement Taken With Chemotherapy Treatments in Patients With Adjuvant Breast Cancer Taken Care of at the Day Hospital

Acronym: CIVCAP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 22, 2019
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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