Intravenous Chemotherapy and Plant-based Dietary Supplements (CIVCAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: dietary supplements questionary

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Saint Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of the ICO René Gauducheau taken care at day hospital for IV chemotherapy treatment of breast cancer in neoadjuvant and/or adjuvant situation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dietary supplements group; dietary supplements questionary	Other: dietary supplements questionary; Patient Questionary Patient to be carried out at the last cure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy	rate of patients taking a dietary supplement	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Description of dietary supplements taken	Description of different types of dietary supplements	12 months

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: Emmanuelle BOURBOULOUX, MD, ICO

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): May 13, 2020
• Study Completion (Actual): May 13, 2020

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; chemotherapy; dietary supplements; Desmodium
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ICO-N-2018-12; 2018-A02460-55 (Registry Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No