Breast CancerCIVCAPNCT03959618
Intravenous Chemotherapy and Plant-based Dietary Supplements
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
More and more patients report taking dietary supplements based on herbal medicine, aromatherapy, vitamintherapy,... in the course of their detoxifying anticancer chemotherapy, to stimulate the immune defenses, to relieve and/or decrease the side effects of chemo or even to act against cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- dietary supplements questionary
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2019to 13 May 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 of the ICO René Gauducheau taken care at day hospital for IV chemotherapy treatment of breast cancer in neoadjuvant and/or adjuvant situation.
Who may be able to join
- breast cancer treated by intra-venous chemotherapy
- all chemotherapy cycles realised at ICO
Who cannot join
- no breast cancer
- metastatic breast cancer
- not all chemotherapy cycles realised at ICO
- patient who has not finished his chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mono-centric, Prospective, Non-Interventional Study of Quantitative and Qualitative Analysis of Dietary Supplement Taken With Chemotherapy Treatments in Patients With Adjuvant Breast Cancer Taken Care of at the Day Hospital
More and more patients report taking dietary supplements based on herbal medicine, aromatherapy, vitamintherapy,... in the course of their detoxifying anticancer chemotherapy, to stimulate the immune defenses, to relieve and/or decrease the side effects of chemo or even to act against cancer. At European level, there are between 15 and 73% of patients treated for cancer taking a dietary supplement (in particular phytotherapy) or a great heterogeneity according to the studies. However, there is still little evidence of the efficacy of these dietary supplements. A large proportion of patients do not seem to inform their doctor about the use of dietary supplements. Patients using dietary supplements most often ignore the mode of action of these products and generally say they are not informed.
In 2015, at the West Cancerology Institute (ICO), 5 patient files were analyzed taking this type of treatment in addition to chemotherapy; in 2016, 24 files; 2017, 61 patient records and this continues to progress.
Read more
At the same time, a product appears very frequently associated with cancer chemotherapy: Desmodium Adscendens, an African plant with in vitro properties of liver protector. The Desmodium contains triterpene saponins, alkaloids, flavonoids, polyphenols, and tryptamine derivatives.
Morevover, several situations of patients undergoing chemotherapy and taking long-term Desmodium, with hepatic cytolyses were experienced, not explained by the usual treatments (case described in the literature).
Therefore, this study will evaluate these new therapeutic modalities that are included in the intake of chemotherapy in order to better know them to improve the therapeutic taking of patients and to focus on the impact of Desmodium in association with chemotherapy.
Read the detailed description
- Determine the quantitative impact of the use of dietary supplements by patients with breast cancer and treated in a neo-adjuvant and/or adjuvant condition by IV chemotherapy in day hospital.
- Determine an over-risk of disruption of liver balance in the population of patients taking Desmodium.
- Gather a critical mass of relevant information with the objective of carrying out the evaluation and analysis of cancer care practices related to the intake of dietary supplements.
- Conditions
- Breast Cancer
- Being tested
- dietary supplements questionary
- Keywords
- dietary supplements, Desmodium, chemotherapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplements questionaryOther
Patient Questionary Patient to be carried out at the last cure
| Study group | Role | What they receive |
|---|---|---|
| dietary supplements group | dietary supplements questionary Receives: Other: dietary supplements questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy
rate of patients taking a dietary supplement
Measured: 12 months
Secondary outcomes (2)
Evaluate the impact of taking Desmodium between the first and last cycle of treatment
% of patients with hepatic cytolysis undergoing chemotherapy between the first and last treatments
Measured: 12 months
Description of dietary supplements taken
Description of different types of dietary supplements
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start2 Apr 2019
- Primary completion13 May 2020
- Study completion13 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle BOURBOULOUX, MD, Principal investigator, ICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959618
- Sponsor's protocol ID
- ICO-N-2018-12
- Other IDs
- 2018-A02460-55
- Acronym
- CIVCAP
- Status last verified
- May 2021
- First submitted
- 15 May 2019
- Last updated
- 21 May 2021
- 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 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mono-centric, Prospective, Non-Interventional Study of Quantitative and Qualitative Analysis of Dietary Supplement Taken With Chemotherapy Treatments in Patients With Adjuvant Breast Cancer Taken Care of at the Day Hospital
- ClinicalTrials.gov ID
- NCT03959618
- Acronym / sponsor ID
- CIVCAP / ICO-N-2018-12
- Conditions
- Breast Cancer
- Keywords
- dietary supplements, Desmodium, chemotherapy, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 22 May 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.
More and more patients report taking dietary supplements based on herbal medicine, aromatherapy, vitamintherapy,... in the course of their detoxifying anticancer chemotherapy, to stimulate the immune defenses, to relieve and/or decrease the side effects of chemo or even to act against cancer. At European level, there are between 15 and 73% of patients treated for cancer taking a dietary supplement (in particular phytotherapy) or a great heterogeneity according to the studies. However, there is still little evidence of the efficacy of these dietary supplements. A large proportion of patients do not seem to inform their doctor about the use of dietary supplements. Patients using dietary supplements most often ignore the mode of action of these products and generally say they are not informed.
In 2015, at the West Cancerology Institute (ICO), 5 patient files were analyzed taking this type of treatment in addition to chemotherapy; in 2016, 24 files; 2017, 61 patient records and this continues to progress.
At the same time, a product appears very frequently associated with cancer chemotherapy: Desmodium Adscendens, an African plant with in vitro properties of liver protector. The Desmodium contains triterpene saponins, alkaloids, flavonoids, polyphenols, and tryptamine derivatives.
Morevover, several situations of patients undergoing chemotherapy and taking long-term Desmodium, with hepatic cytolyses were experienced, not explained by the usual treatments (case described in the literature).
Therefore, this study will evaluate these new therapeutic modalities that are included in the intake of chemotherapy in order to better know them to improve the therapeutic taking of patients and to focus on the impact of Desmodium in association with chemotherapy.
Detailed description
- Determine the quantitative impact of the use of dietary supplements by patients with breast cancer and treated in a neo-adjuvant and/or adjuvant condition by IV chemotherapy in day hospital.
- Determine an over-risk of disruption of liver balance in the population of patients taking Desmodium.
- Gather a critical mass of relevant information with the objective of carrying out the evaluation and analysis of cancer care practices related to the intake of dietary supplements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dietary supplements group | – | Other: dietary supplements questionarydietary supplements questionary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the ICO René Gauducheau taken care at day hospital for IV chemotherapy treatment of breast cancer in neoadjuvant and/or adjuvant situation.
Key inclusion criteria (2 listed)
- breast cancer treated by intra-venous chemotherapy
- all chemotherapy cycles realised at ICO
Key exclusion criteria (4 listed)
- no breast cancer
- metastatic breast cancer
- not all chemotherapy cycles realised at ICO
- patient who has not finished his chemotherapy
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 |
|---|---|---|
| dietary supplements questionaryPatient Questionary Patient to be carried out at the last cure | Other | dietary supplements group |
Primary outcome
evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy
Time frame: 12 months
rate of patients taking a dietary supplement
2 secondary outcomes
Evaluate the impact of taking Desmodium between the first and last cycle of treatment
Time frame: 12 months
Description of dietary supplements taken
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
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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.
Emmanuelle BOURBOULOUX, MD principal investigator
ICO
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 Breast Cancer, run by Institut Cancerologie de l'Ouest 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 21 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy (time frame: 12 months). 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 21 May 2021.