Intravenous Chemotherapy and Plant-based Dietary Supplements

NCT ID: NCT03959618

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2020-05-13

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

dietary supplements group

dietary supplements questionary

dietary supplements questionary

Intervention Type: OTHER

Patient Questionary Patient to be carried out at the last cure

Interventions

dietary supplements questionary

Patient Questionary Patient to be carried out at the last cure

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle BOURBOULOUX, MD

Role: PRINCIPAL_INVESTIGATOR

ICO

Locations

Institut de Cancerologie de L'Ouest

Saint-Herblain, , France

Countries

France

Other Identifiers

2018-A02460-55

Identifier Type: REGISTRY

Identifier Source: secondary_id

ICO-N-2018-12

Identifier Type: -

Identifier Source: org_study_id