CancerJEUNETCHIMIONCT03840213
Nutrition and Chemotherapy
An observational study of Cancer, run by Institut de Cancérologie de la Loire at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Filling a questionnaire and interviewDescription
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2019to 30 Sep 2020
- 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: 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.
Who may be able to join
- 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:
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Véronique Régnier-Denois, 04.77.91.74.75 ext. +33, veronique.regnier@icloire.fr
Pierre Fournel, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Filling a questionnaire and interviewDescription
- Keywords
- Chemotherapy, nutrition, self-care, care/caregiver relationship, fasting
- Medical subject headings
- Neoplasms, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling a questionnaire and interviewDescriptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing chemotherapy treatment | Patients over 18 years of age, followed at the ICLN day hospital or hospitalized and undergoing chemotherapy treatment Receives: Behavioral: Filling a questionnaire and interviewDescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who voluntarily changed their eating habits
Number of patients who voluntarily changed their eating habits will be reported
Measured: 1 year
Secondary outcomes (4)
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
Measured: 1 year
Number of patients using complementary or alternative medicines
Number of patients using complementary or alternative medicines will be reported
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start20 Feb 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Sep 2020 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Pierre Fournel, MD, Principal investigator, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840213
- Sponsor's protocol ID
- 2019-0101SP
- Other IDs
- 2019-A00093-54
- Acronym
- JEUNETCHIMIO
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Chemotherapy, Representation and Practice in a Cancer Care Centre (JEUNETCHIMIO)
- ClinicalTrials.gov ID
- NCT03840213
- Acronym / sponsor ID
- JEUNETCHIMIO / 2019-0101SP
- Conditions
- Cancer
- Keywords
- Chemotherapy, nutrition, self-care, care/caregiver relationship, fasting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 20 Feb 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 15 Feb 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing chemotherapy treatment | – | Behavioral: Filling a questionnaire and interviewDescriptionPatients over 18 years of age, followed at the ICLN day hospital or hospitalized and undergoing chemotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filling a questionnaire and interviewDescriptionThe 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. | Behavioural | Patients undergoing chemotherapy treatment |
Primary outcome
Number of patients who voluntarily changed their eating habits
Time frame: 1 year
Number of patients who voluntarily changed their eating habits will be reported
4 secondary outcomes
Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment
Time frame: 1 year
Number of patients using complementary or alternative medicines
Time frame: 1 year
Number of patients discussing these different practices with their oncologist
Time frame: 1 year
Number of patients discussing these different practices with other caregivers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
RecruitingPhase 3
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
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.
Pierre Fournel, MD principal investigator
Institut de Cancérologie Lucien Neuwirth
1 site 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 Institut de Cancérologie de la Loire at 1 site 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 5 inclusion and 3 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Pierre Fournel, MD (04 77 91 70 00 ext. +33, pierre.fournel@icloire.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who voluntarily changed their eating habits (time frame: 1 year). 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 15 Feb 2019.