Intravenous Chemotherapy and Plant-based Dietary Supplements

NCT03959618 | Completed

• 2 other identifiers: ICO-N-2018-122018-A02460-55
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

dietary supplements; Desmodium; chemotherapy; breast cancer

Outcome Measures

Primary Outcomes (1)

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

  rate of patients taking a dietary supplement

  12 months

Secondary Outcomes (2)

• Evaluate the impact of taking Desmodium between the first and last cycle of treatment

  12 months

• Description of dietary supplements taken

  12 months

Study Arms (1)

dietary supplements group

dietary supplements questionary

Other: dietary supplements questionary

Interventions

dietary supplements questionary OTHER

Patient Questionary Patient to be carried out at the last cure

dietary supplements group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• breast cancer treated by intra-venous chemotherapy
• all chemotherapy cycles realised at ICO

You may not qualify if:

• no breast cancer
• metastatic breast cancer
• not all chemotherapy cycles realised at ICO
• patient who has not finished his chemotherapy

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Emmanuelle BOURBOULOUX, MD

  ICO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 22, 2019
• Study Start: April 2, 2019
• Primary Completion: May 13, 2020
• Study Completion: May 13, 2020
• Last Updated: May 21, 2021

Record last verified: 2021-05

Locations

FR (1)