Nutrition and Chemotherapy (JEUNETCHIMIO)

Nutrition and Chemotherapy, Representation and Practice in a Cancer Care Centre (JEUNETCHIMIO)

Patients treated for cancer nowadays have many means of information and tend to become more and more involved in their health. The interest of a therapeutic fast with detoxifying or even curative properties, with a specific indication for cancer patients treated by chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on the scope of this information in cancer patients or on the attitudes of oncologists towards this practice and possible positioning requests from patients.

We hypothesize that the choice of this practice and its modalities are rarely discussed with oncologists, although it may have deleterious repercussions on the patient's health.

We propose a research based on the principles of sociological intervention. Its objectives are a first review of the issue and the establishment of a joint working group, including patients, carers and researchers, which will propose solutions to improve the patient/carer dialogue on this issue.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Filling a questionnaire and interviewDescription

Detailed Description

Patients treated for cancer nowadays have many means of information and tend to become more and more involved in their health. The interest of a therapeutic fast with detoxifying or even curative properties, with a specific indication for cancer patients treated by chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on the scope of this information in cancer patients or on the attitudes of oncologists towards this practice and possible positioning requests from patients.

We hypothesize that the choice of this practice and its modalities are rarely discussed with oncologists, although it may have deleterious repercussions on the patient's health.

We propose a research based on the principles of sociological intervention. Its objectives are a first review of the issue and the establishment of a joint working group, including patients, carers and researchers, which will propose solutions to improve the patient/carer dialogue on this issue.

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

Contacts and Locations

• Study Contact: Name: Pierre Fournel, MD; Phone Number: +33 04 77 91 70 00; Email: pierre.fournel@icloire.fr
• Study Contact Backup: Name: Véronique Régnier-Denois; Phone Number: +33 04 77 91 74 75; Email: veronique.regnier@icloire.fr

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • Institut de Cancérologie Lucien Neuwirth
    • Principal Investigator: Pierre Fournel, MD
    • Sub-Investigator: Jean-Philippe Jacquin, MD
    • Sub-Investigator: Thierry Muron, MD
    • Sub-Investigator: Romain Rivoirard, MD
    • Sub-Investigator: Léa Saban-Roche, MD
    • Contact: Véronique Régnier-Denois; Phone Number: +33 04.77.91.74.75; Email: veronique.regnier@icloire.fr
    • Sub-Investigator: Olivier Collard, MD

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

Patients who intend to practice, or who practice a form of fasting during their chemotherapy treatment will be proposed to participate to a qualitative study to collect more information about their fasting.

Description

Inclusion Criteria:

• Major patients, follow-up on Institut de Cancerology Lucien Neuwirth day service chemotherapy treatment
• Patient affiliated or entitled to a social security scheme
• Patient who received informed information about the study
• Patient able to read French

Patients participating in the qualitative study:

Exclusion Criteria:

• Refusal to participate, protected adult person, under guardianship or curatorship
• Person unable to understand the conduct of the study
• Person with a documented history of cognitive or psychiatric disorders

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing chemotherapy treatment; Patients over 18 years of age, followed at the ICLN day hospital or hospitalized and undergoing chemotherapy treatment	Behavioral: Filling a questionnaire and interviewDescription; The questionnaire focuses on the dietary practices of patients treated with chemotherapy. It consists of 35 questions, completing an average of 20 minutes. Interviews will be conducted with patients who have changed their diet since the beginning of their treatment in order to further develop the results of the quantitative survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who voluntarily changed their eating habits	Number of patients who voluntarily changed their eating habits will be reported	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment	Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment will be reported	1 year
Number of patients using complementary or alternative medicines	Number of patients using complementary or alternative medicines will be reported	1 year
Number of patients discussing these different practices with their oncologist	Number of patients discussing these different practices with their oncologist will be reported	1 year
Number of patients discussing these different practices with other caregivers	Number of patients discussing these different practices with other caregivers will be reported	1 year

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de la Loire
• Collaborators: Ligue contre le cancer, France
• Investigators: Principal Investigator: Pierre Fournel, MD, Institut de Cancérologie Lucien Neuwirth

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: nutrition; Chemotherapy; fasting; self-care; care/caregiver relationship
• Other Study ID Numbers: 2019-0101SP; 2019-A00093-54 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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