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CompletedNCT03959618CIVCAPUpdated May 21, 2021

Intravenous Chemotherapy and Plant-based Dietary Supplements

An observational study in Breast Cancer, sponsored by Institut Cancerologie de l'Ouest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-21.

Sponsored by Institut Cancerologie de l'Ouest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Breast Cancer

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Keywords

  • dietary supplements
  • Desmodium
  • chemotherapy
  • breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 200 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Institut Cancerologie de l'Ouest is the lead sponsor of 105 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • dietary supplements group

    dietary supplements questionary

    Other: dietary supplements questionary

Interventions

  • Otherdietary supplements questionary

    Patient Questionary Patient to be carried out at the last cure

06

What researchers measure

Primary outcomes

  1. evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy

    rate of patients taking a dietary supplement

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 12 months

  2. Description of dietary supplements taken

    Description of different types of dietary supplements

    Time frame: 12 months

07

Study locations

1 site
  • Institut de Cancerologie de L'Ouest
    Saint Herblain, 44805, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03959618
Lead sponsor
Institut Cancerologie de l'Ouest
Responsible party
Sponsor
First posted
May 22, 2019
Start date
Apr 2, 2019
Primary completion
May 13, 2020
Completion
May 13, 2020
Last update
May 21, 2021

Study contacts

Emmanuelle BOURBOULOUX, MD
principal investigator · ICO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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