Intravenous Chemotherapy and Plant-based Dietary Supplements (CIVCAP)
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|ClinicalTrials.gov Identifier: NCT03959618|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: dietary supplements questionary|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official 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|
|Actual Study Start Date :||April 2, 2019|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||April 2, 2020|
dietary supplements group
dietary supplements questionary
Other: dietary supplements questionary
Patient Questionary Patient to be carried out at the last cure
- evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy [ Time Frame: 12 months ]rate of patients taking a dietary supplement
- 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
- Description of dietary supplements taken [ Time Frame: 12 months ]Description of different types of dietary supplements
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959618
|Contact: Laurence DUMAS, MD||+ 33 2 40 67 97 firstname.lastname@example.org|
|Contact: Laëtitia HIMPE||+33 2 40 67 97 email@example.com|
|Institut de Cancerologie de L'Ouest||Recruiting|
|Saint Herblain, France, 44805|
|Contact: Laurence DUMAS, MD firstname.lastname@example.org|
|Contact: Emmanuelle BOURBOULOUX, MD email@example.com|
|Principal Investigator:||Emmanuelle BOURBOULOUX, MD||ICO|