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Intravenous Chemotherapy and Plant-based Dietary Supplements (CIVCAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03959618
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : January 23, 2020
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

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.

Condition or disease Intervention/treatment
Breast Cancer 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : September 2, 2020
Estimated Study Completion Date : September 2, 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy [ Time Frame: 12 months ]
    rate of patients taking a dietary supplement

Secondary Outcome Measures :
  1. Evaluate the impact of taking Desmodium between the first and last cycle of treatment [ Time Frame: 12 months ]
    % of patients with hepatic cytolysis undergoing chemotherapy between the first and last treatments

  2. Description of dietary supplements taken [ Time Frame: 12 months ]
    Description of different types of dietary supplements

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03959618

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Contact: Laurence DUMAS, MD + 33 2 40 67 97 47
Contact: Laëtitia HIMPE +33 2 40 67 97 47

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Institut de Cancerologie de L'Ouest Recruiting
Saint Herblain, France, 44805
Contact: Laurence DUMAS, MD   
Contact: Emmanuelle BOURBOULOUX, MD   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
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Principal Investigator: Emmanuelle BOURBOULOUX, MD ICO
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Responsible Party: Institut Cancerologie de l'Ouest Identifier: NCT03959618    
Other Study ID Numbers: ICO-N-2018-12
2018-A02460-55 ( Registry Identifier: ID RCB )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
dietary supplements
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases