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

Hopital Foch

Status: Completed

Conditions: Vomiting; Nausea

Treatments: Other: Acupuncture; Other: Auriculotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02767791

2015/34

2015-A01988-41 (Other Identifier)

Details and patient eligibility

About

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/.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 4 patient groups

Acupuncture

Active Comparator group

Description:

Acupuncture wrist 6

Treatment:

Other: Acupuncture

Auriculotherapy

Active Comparator group

Description:

Auriculotherapy

Treatment:

Other: Auriculotherapy

Auriculotherapy and acupuncture

Experimental group

Description:

Auriculotherapy and acupuncture

Treatment:

Other: Acupuncture

Other: Auriculotherapy

No treatment

No Intervention group

Description:

No treatment