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

Cancer Clinical Trial

— PRINCESSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128865
• Other study ID #: CIC1421-18-07
• Status: Recruiting
• Start date: April 13, 2018
• Est. completion date: November 11, 2019

Study information

• Verified date: October 2019
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: Paul Gougis, MD
• Phone: (0)1 42 17 85 33
• Email: paul.gougis[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 11, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique Paris-Est	Paris
France	Centre d'Investigation Clinique Paris-Est	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Paul Gougis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measure of the rate of patients having a consumption of at least 1 phytotherapy, aspecific food (which is a specific ingredient that is eaten daily, like daily consumption of grapefruit juice or green tea) or a dietary supplement and having a likely interaction (justified through a clinically proven cytochrome interaction or direct interaction) with their anticancer treatment. The interaction could be through an inhibition of a major CYP in the metabolism of the chemotherapy. Each potential interaction will be searched in the literature.; Anticancer treatments include chemotherapy, targeted therapies, hormonotherapies, radiotherapy or surgery.	1 day
Secondary	Rate of patients using HFDS		1 day
Secondary	Description of the population using HFDS (age, primory tumor, tumor stage : local or metastasis,		1 day
Secondary	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.		1 day