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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-04

Study Completion Date

2021-06-07

Brief Summary

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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/.

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Detailed Description

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Conditions

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Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

Acupuncture wrist 6

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

Acupuncture

Auriculotherapy

Group Type ACTIVE_COMPARATOR

Auriculotherapy

Intervention Type OTHER

Auriculotherapy

Auriculotherapy and acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Acupuncture

Auriculotherapy

Intervention Type OTHER

Auriculotherapy

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

Intervention Type OTHER

Auriculotherapy

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No