Clinical trial NCT03959618: Intravenous Chemotherapy and Plant-based Dietary Supplements
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: dietary supplements
Desmodium
chemotherapy
breast cancer
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate the impact of taking Desmodium between the first and last cycle of treatment
timeFrame: 12 months
measure: Description of dietary supplements taken
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Herblain
country: France
facility: Institut de Cancerologie de L'Ouest
Study officials:
affiliation: ICO
name: Emmanuelle BOURBOULOUX, MD
role: PRINCIPAL_INVESTIGATOR
References: