Clinical trial NCT04128865: PRevention of INteractions Between Phytotherapies and CancEr Treatments by a SmartphonE/Tablet Automated SurvEy
Official title: PRevention of INteractions Between Phytotherapies and CancEr Treatments by a SmartphonE/Tablet Automated SurvEy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: phytotherapy
dietary supplement
food interaction
herb-drug interactions
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of patient is composed of patient treated for different kind of cancer and which are using daily HFDS

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.

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.

Primary outcomes:
measure: Rate of interaction between HFDS (herb food and dietary supplements) and anticancer drugs whith a level of evidence graded as "likely" (clinical evidence) in a cohort of cancer patient using at least 1 HFDS daily.
timeFrame: 1 day
Secondary outcomes:
measure: Rate of patients using HFDS
timeFrame: 1 day
measure: Description of the population using HFDS (age, primory tumor, tumor stage : local or metastasis,
timeFrame: 1 day
measure: Rate of interaction between HFDS and anticancer drugs whith a level of evidence graded as "possible" (clinical evidence) in a cohort of cancer patient using at least 1 HFDS daily.
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique Paris-Est
city: Paris
country: France
facility: Centre d'Investigation Clinique Paris-Est
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Olivier Mir, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: