CancerPRINCESSENCT04128865
PRevention of INteractions Between Phytotherapies and CancEr Treatments by a SmartphonE/Tablet Automated SurvEy
An observational study of Cancer, run by Paul Gougis at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Apr 2018to 11 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of patient is composed of patient treated for different kind of cancer and which are using daily HFDS
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
Centre d'Investigation Clinique Paris-Est
Paris, 75013
Paul Gougis, MD, (0)142178533 ext. +33, paul.gougis@aphp.fr
- Recruiting
Centre d'Investigation Clinique Paris-Est
Paris, 75013
Paul Gougis, MD, (0)1 42 17 85 33 ext. +33, paul.gougis@aphp.fr
About this study
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.
Read the 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
- Keywords
- phytotherapy, dietary supplement, food interaction, herb-drug interactions
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
Rate of patients using HFDS
Measured: 1 day
Description of the population using HFDS (age, primory tumor, tumor stage : local or metastasis,
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start13 Apr 2018
- Primary completion10 Nov 2019 (estimated)
- Study completion11 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Gougis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Gougis, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Olivier Mir, MD-PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128865
- Sponsor's protocol ID
- CIC1421-18-07
- Acronym
- PRINCESSE
- Status last verified
- Oct 2019
- First submitted
- 10 Apr 2018
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRevention of INteractions Between Phytotherapies and CancEr Treatments by a SmartphonE/Tablet Automated SurvEy
- ClinicalTrials.gov ID
- NCT04128865
- Acronym / sponsor ID
- PRINCESSE / CIC1421-18-07
- Conditions
- Cancer
- Keywords
- phytotherapy, dietary supplement, food interaction, herb-drug interactions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Paul GougisUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 10 Nov 2019 (estimated)
- Study completion
- 11 Nov 2019 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of patient is composed of patient treated for different kind of cancer and which are using daily HFDS
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 1 day
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.
3 secondary outcomes
Rate of patients using HFDS
Time frame: 1 day
Description of the population using HFDS (age, primory tumor, tumor stage : local or metastasis,
Time frame: 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.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Mir, MD-PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Paul Gougis at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Gougis, MD ((0)1 42 17 85 33 ext. +33, paul.gougis@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.