Intravenous Chemotherapy and Plant-based Dietary Supplements

Breast Cancer Clinical Trial

— CIVCAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959618
• Other study ID #: ICO-N-2018-12
• Secondary ID: 2018-A02460-55
• Status: Completed
• Start date: April 2, 2019
• Est. completion date: May 13, 2020

Study information

• Verified date: May 2021
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 13, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• dietary supplements questionary
Patient Questionary Patient to be carried out at the last cure

Locations

Country	Name	City	State
France	Institut de Cancerologie de L'Ouest	Saint Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy	rate of patients taking a dietary supplement	12 months
Secondary	Evaluate the impact of taking Desmodium between the first and last cycle of treatment	% of patients with hepatic cytolysis undergoing chemotherapy between the first and last treatments	12 months
Secondary	Description of dietary supplements taken	Description of different types of dietary supplements	12 months