Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV) (NVCI)
Primary Purpose
Nausea, Vomiting
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Acupuncture
Auriculotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Nausea
Eligibility Criteria
Inclusion Criteria:
- out-patient chemotherapy
- treated nausea vomiting induced by chemotherapy (NVIC)
Exclusion Criteria:
- 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
Sites / Locations
- Centre hospitalier de Gonesse
- René Huguenin
- Centre spécilaisé en cancérologie Paris Nord
- Clinique de l'Estrée
- Hopital Foch
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
No Intervention
Arm Label
Acupuncture
Auriculotherapy
Auriculotherapy and acupuncture
No treatment
Arm Description
Acupuncture wrist 6
Auriculotherapy
Auriculotherapy and acupuncture
No treatment
Outcomes
Primary Outcome Measures
Digital Scale for nausea
Digital Scale for nausea (H24 MAT score)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02767791
Brief Title
Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)
Acronym
NVCI
Official Title
Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2016 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
June 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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/.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
Acupuncture wrist 6
Arm Title
Auriculotherapy
Arm Type
Active Comparator
Arm Description
Auriculotherapy
Arm Title
Auriculotherapy and acupuncture
Arm Type
Experimental
Arm Description
Auriculotherapy and acupuncture
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture
Intervention Type
Other
Intervention Name(s)
Auriculotherapy
Intervention Description
Auriculotherapy
Primary Outcome Measure Information:
Title
Digital Scale for nausea
Description
Digital Scale for nausea (H24 MAT score)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
out-patient chemotherapy
treated nausea vomiting induced by chemotherapy (NVIC)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireille Michel-Cherqui, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de Gonesse
City
Gonesse
Country
France
Facility Name
René Huguenin
City
Saint-Cloud
Country
France
Facility Name
Centre spécilaisé en cancérologie Paris Nord
City
Sarcelles
ZIP/Postal Code
95200
Country
France
Facility Name
Clinique de l'Estrée
City
Stains
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)
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