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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.
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 :
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.
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| 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The population of patient is composed of patient treated for different kind of cancer and which are using daily HFDS
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Gougis, MD | Contact | (0)1 42 17 85 33 | +33 | paul.gougis@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Olivier Mir, MD-PhD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique Paris-Est | Not yet recruiting | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 1 day |
| Centre d'Investigation Clinique Paris-Est | Recruiting | Paris | 75013 | France |
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