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

NCT04128865 | Unknown

• 1 other identifier: CIC1421-18-07
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

phytotherapy; dietary supplement; food interaction; herb-drug interactions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paul Gougis: lead

Study Sites (2)

Centre d'Investigation Clinique Paris-Est

Paris, 75013, France

NOT YET RECRUITING

Centre d'Investigation Clinique Paris-Est

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Olivier Mir, MD-PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Gougis, MD

CONTACT

(0)1 42 17 85 33; paul.gougis@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: October 16, 2019
• Study Start: April 13, 2018
• Primary Completion: November 10, 2019
• Study Completion: November 11, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

FR (2)