PRevention of INteractions Between Phytotherapies and CancEr Treatments by a SmartphonE/Tablet Automated SurvEy

NCT ID: NCT04128865

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-13
• Study Completion Date: 2019-11-11

Brief Summary

The use of phytotherapies or specific food or dietary supplement (HFDS) is common among cancer patients. They can also be responsible of clinically relevant interaction with anti-cancer treatments. This study aims at assessing the proportion patients using HFDS which are likely to have an interaction with their anticancer treatments. The data is collected through a smartphone/tablet application. The aim of the study is to demonstrate that clinically significant herb-drug interaction with anticancer treatment could be avoid using these devices.

Detailed Description

The use of herbal treatment, also called phytotherapies, or dietary supplements or specific food (herbs, food or dietary supplements HFDS) is very common and have been evaluated between 30 and 70%, depending on the population and the studies.However, few studies have been made to evaluate the risk of interaction with oncology treatment in real life. Some interaction are very well known by both patients and clinicians, like the inhibition of the cytochrome 3A4 by grapefruit or the induction of the CYP3A4 by Saint John's Wort. However, many other interactions have been demonstrated, like the inhibition of the CYP3A4 by goldenseal extracts (among many others) although this is frequently used phytotherapy, both over the counter or "prescribed" by herb specialists.

This study aims at demonstrating that a smartphone or tablet application could be used to prevent significant interaction between phytotherapy or food or dietary supplements with anticancer treatments.

The application is used to collect data prospectively that will be analysed for interaction retrospectively. The interactions between phytotherapy have been classified in 4 categories :

• likely (clinically relevant data in the literature between the herb and the anticancer treatment either directly or through documented CYP interaction)
• possible (animal model or in vitro data in favor of an interaction)
• unlikely (clinical data or animal model or in vitro data in favor of no interaction)
• unknown (no data available or data from that could not allow a conclusion due to its poor quality or an ambiguous conclusion) The investigators aim at measuring the proportion of "likely" herb-drug interaction (or dietary supplement or food) in a population of patients followed and treated for a cancer, either local or metastatic.

The investigators also aim at characterizing the population, quantifying the proportion of patients taking HFDS and, to measure the proportion of "possible" herb-drug interaction.

Conditions

Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Men or women over 18 years old
• Subject currently receiving a treatment for cancer or who has a planned treatment (radiotherapy, surgery, chemotherapy, hormonotherapy, targeted therapy or other procedure)

Exclusion Criteria

• The subject is not able to read
• The subject is not using any herb, food or dietary supplement with a daily consumption.
• The subject refuses to be part of the study
• The subject does not know the name of the anticancer therapy that he receives.
• The subject does not know if he uses either phytotherapy, specific food consumed daily or dietary supplements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paul Gougis

OTHER

Sponsor Role: lead

Responsible Party

Paul Gougis

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Olivier Mir, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Centre d'Investigation Clinique Paris-Est

Paris, , France

Site Status: NOT_YET_RECRUITING

Centre d'Investigation Clinique Paris-Est

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Paul Gougis, MD

Role: CONTACT

paul.gougis@aphp.fr

(0)1 42 17 85 33 ext. +33

Facility Contacts

Paul Gougis, MD

Role: primary

paul.gougis@aphp.fr

(0)142178533 ext. +33

Paul Gougis, MD

Role: primary

paul.gougis@aphp.fr

(0)1 42 17 85 33 ext. +33

Other Identifiers

CIC1421-18-07

Identifier Type: -

Identifier Source: org_study_id