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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Paul Gougis, MD; Phone Number: +33 (0)1 42 17 85 33; Email: paul.gougis@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Not yet recruiting
    • Centre d'Investigation Clinique Paris-Est
    • Contact: Paul Gougis, MD; Phone Number: +33 (0)142178533; Email: paul.gougis@aphp.fr
  • Paris, France, 75013
    • Recruiting
    • Centre d'Investigation Clinique Paris-Est
    • Contact: Paul Gougis, MD; Phone Number: +33 (0)1 42 17 85 33; Email: paul.gougis@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Rate of patients using HFDS	1 day
Description of the population using HFDS (age, primory tumor, tumor stage : local or metastasis,	1 day
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

Collaborators and Investigators

• Sponsor: Paul Gougis
• Investigators: Principal Investigator: Olivier Mir, MD-PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2018
• Primary Completion (Anticipated): November 10, 2019
• Study Completion (Anticipated): November 11, 2019

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: phytotherapy; dietary supplement; food interaction; herb-drug interactions
• Other Study ID Numbers: CIC1421-18-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No