NauseaNVCINCT02767791
Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)
A study testing Acupuncture and Auriculotherapy in people with Nausea and Vomiting, run by Hopital Foch at 5 sites in France.
Trial summary
The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years and became less frequent. CINV include early (occurring within 24 hours of chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acupuncture and Auriculotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 5 sitesFrance
- Study dates
- 4 May 2016to 7 Jun 2021
- Phase
- Interventional
- 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
Who may be able to join
- out-patient chemotherapy
- treated nausea vomiting induced by chemotherapy (NVIC)
Who cannot join
- prior treatment with acupuncture and or auriculotherapy for NVIC
- no conventional treatment for NVIC like phytotherapy and homeopathy
- radiotherapy (five days before and 5 days after chemotherapy)
- MRI in the five days after first visit
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre hospitalier de Gonesse
Gonesse
René Huguenin
Saint-Cloud
Centre spécilaisé en cancérologie Paris Nord
Sarcelles, 95200
Clinique de l'Estrée
Stains
Hopital Foch
Suresnes, 92150
About this study
The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years and became less frequent. CINV include early (occurring within 24 hours of chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting.
Preventive treatment, such as Glucocorticoids, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists and neurokinin 1 (NK1) receptor antagonists, are administered according to the classification in 4 grades of expected CINV
Read more
- Very low: <10% occurrence of CINV;
- Low: 10 to 30% occurrence of CINV;
- Average: 30 to 90% occurrence of CINV;
- High: > 90% occurrence of CINV. These treatments have been the subject of recommendations. Despite these available treatments, some patients still complain of vomiting, or more frequently nausea and loss of appetite.
Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as complementary treatment, mainly in the acute phase and to a lesser extent in the delayed phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture needles, electro-acupuncture or acupressure.
Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and postoperative nausea, but, to our knowledge, there are no studies published on the effect of auriculotherapy on CINV.
These complementary treatments have virtually no side effects. In our institution, a simple treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular point treated) is regularly use in patients who present CINV despite preventive treatment and most of them are relieved.
The investigators propose a clinical trial in this population to assess symptoms improvement in patients presenting CINV after their first administration of chemotherapy despite adapted preventive treatment. Experimental treatment with semi-permanent needles takes place during administration of the second session of chemotherapy. CINV are evaluated through the (MAT) score that measures the frequency and intensity of nausea and vomiting in the 24 hours following the session and during the 4 days after administration Chemotherapy.
Multinational Association of Supportive Care in Cancer Antiemesis Tool (MASCC), Http://www.MASCC.org/.
- Being tested
- Acupuncture, Auriculotherapy
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture
AuriculotherapyOther
Auriculotherapy
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Acupuncture wrist 6 Receives: Other: Acupuncture |
| Auriculotherapy | Active comparator | Auriculotherapy Receives: Other: Auriculotherapy |
| Auriculotherapy and acupuncture | Experimental | Auriculotherapy and acupuncture Receives: Other: Acupuncture; Other: Auriculotherapy |
| No treatment | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Scale for nausea
Digital Scale for nausea (H24 MAT score)
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 posted10 May 2016 (estimated)
- Study start4 May 2016
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille Michel-Cherqui, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767791
- Sponsor's protocol ID
- 2015/34
- Other IDs
- 2015-A01988-41
- Acronym
- NVCI
- Status last verified
- Aug 2021
- First submitted
- 4 May 2016
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Michel-Cherqui M, Ma S, Bacrie J, Huguet S, Lemaire N, Le Guen M, Fischler M. Auriculotherapy and acupuncture treatments for chemotherapy-induced nausea and vomiting: a multicenter clinical trial. Support Care Cancer. 2024 Jul 31;32(8):560. doi: 10.1007/s00520-024-08768-w.
PubMed 39085664
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)
- ClinicalTrials.gov ID
- NCT02767791
- Acronym / sponsor ID
- NVCI / 2015/34
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 4 May 2016 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 10 May 2016 (estimated)
- 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 management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years and became less frequent. CINV include early (occurring within 24 hours of chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting.
Preventive treatment, such as Glucocorticoids, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists and neurokinin 1 (NK1) receptor antagonists, are administered according to the classification in 4 grades of expected CINV
- Very low: <10% occurrence of CINV;
- Low: 10 to 30% occurrence of CINV;
- Average: 30 to 90% occurrence of CINV;
- High: > 90% occurrence of CINV. These treatments have been the subject of recommendations. Despite these available treatments, some patients still complain of vomiting, or more frequently nausea and loss of appetite.
Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as complementary treatment, mainly in the acute phase and to a lesser extent in the delayed phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture needles, electro-acupuncture or acupressure.
Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and postoperative nausea, but, to our knowledge, there are no studies published on the effect of auriculotherapy on CINV.
These complementary treatments have virtually no side effects. In our institution, a simple treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular point treated) is regularly use in patients who present CINV despite preventive treatment and most of them are relieved.
The investigators propose a clinical trial in this population to assess symptoms improvement in patients presenting CINV after their first administration of chemotherapy despite adapted preventive treatment. Experimental treatment with semi-permanent needles takes place during administration of the second session of chemotherapy. CINV are evaluated through the (MAT) score that measures the frequency and intensity of nausea and vomiting in the 24 hours following the session and during the 4 days after administration Chemotherapy.
Multinational Association of Supportive Care in Cancer Antiemesis Tool (MASCC), Http://www.MASCC.org/.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Other: AcupunctureAcupuncture wrist 6 |
| Auriculotherapy | Active comparator | Other: AuriculotherapyAuriculotherapy |
| Auriculotherapy and acupuncture | Experimental | Other: Acupuncture, Other: AuriculotherapyAuriculotherapy and acupuncture |
| No treatment | No intervention | –No treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- out-patient chemotherapy
- treated nausea vomiting induced by chemotherapy (NVIC)
Key exclusion criteria (4 listed)
- prior treatment with acupuncture and or auriculotherapy for NVIC
- no conventional treatment for NVIC like phytotherapy and homeopathy
- radiotherapy (five days before and 5 days after chemotherapy)
- MRI in the five days after first visit
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 |
|---|---|---|
| AcupunctureAcupuncture | Other | Acupuncture, Auriculotherapy and acupuncture |
| AuriculotherapyAuriculotherapy | Other | Auriculotherapy, Auriculotherapy and acupuncture |
Primary outcome
Digital Scale for nausea
Time frame: 1 day
Digital Scale for nausea (H24 MAT score)
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 1 Sep 2021.
- Derived from this study: PubMed 39085664Michel-Cherqui M, Ma S, Bacrie J, Huguet S, Lemaire N, Le Guen M, Fischler M. Auriculotherapy and acupuncture treatments for chemotherapy-induced nausea and vomiting: a multicenter clinical trial. Support Care Cancer. 2024 Jul 31;32(8):560. doi: 10.1007/s00520-024-08768-w.
- Individual participant dataSharing planned: No
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Nausea, Vomiting
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.
Mireille Michel-Cherqui, MD principal investigator
Hopital Foch
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Auriculotherapy in people with Nausea and Vomiting, run by Hopital Foch at 5 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 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Digital Scale for nausea (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02767791, which also lists 1 linked publication.
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 1 Sep 2021.