Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)
NVCI
2 other identifiers
interventional
116
1 country
5
Brief 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. 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/.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2016
CompletedStudy Start
First participant enrolled
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2021
CompletedSeptember 1, 2021
August 1, 2021
5.1 years
May 4, 2016
August 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Digital Scale for nausea
Digital Scale for nausea (H24 MAT score)
1 day
Study Arms (4)
Acupuncture
ACTIVE COMPARATORAcupuncture wrist 6
Auriculotherapy
ACTIVE COMPARATORAuriculotherapy
Auriculotherapy and acupuncture
EXPERIMENTALAuriculotherapy and acupuncture
No treatment
NO INTERVENTIONNo treatment
Interventions
Eligibility Criteria
You may qualify if:
- out-patient chemotherapy
- treated nausea vomiting induced by chemotherapy (NVIC)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (5)
Centre hospitalier de Gonesse
Gonesse, France
René Huguenin
Saint-Cloud, France
Centre spécilaisé en cancérologie Paris Nord
Sarcelles, 95200, France
Clinique de l'Estrée
Stains, France
Hopital Foch
Suresnes, 92150, France
Related Publications (1)
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.
PMID: 39085664DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mireille Michel-Cherqui, MD
Hopital Foch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 10, 2016
Study Start
May 4, 2016
Primary Completion
June 7, 2021
Study Completion
June 7, 2021
Last Updated
September 1, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share