Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)

Not Applicable

Completed

• Conditions: Nausea; Vomiting
• Interventions: Other: Acupuncture; Other: Auriculotherapy

• Registration Number: NCT02767791
• Lead Sponsor: Hopital Foch

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/.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-04
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• out-patient chemotherapy
• treated nausea vomiting induced by chemotherapy (NVIC)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	Acupuncture wrist 6
Auriculotherapy	Auriculotherapy	Auriculotherapy
Auriculotherapy and acupuncture	Acupuncture	Auriculotherapy and acupuncture
Auriculotherapy and acupuncture	Auriculotherapy	Auriculotherapy and acupuncture

Primary Outcome Measures

Name	Time	Method
Digital Scale for nausea	1 day	Digital Scale for nausea (H24 MAT score)

Trial Locations

Locations (5)

Hopital Foch; 🇫🇷 Suresnes, France

Centre spécilaisé en cancérologie Paris Nord; 🇫🇷 Sarcelles, France

René Huguenin; 🇫🇷 Saint-Cloud, France

Centre hospitalier de Gonesse; 🇫🇷 Gonesse, France

Clinique de l'Estrée; 🇫🇷 Stains, France