Electric Stimulation on Nausea and Vomit Chemotherapy Induced (TENS-NV)

Federal University of Health Science of Porto Alegre

Status: Unknown

Conditions: Breast Cancer Female; Acupuncture

Treatments: Device: High Frequency Group; Device: Placebo Group; Device: Low Frequency Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03145727

TENS-NV-2017

Details and patient eligibility

About

Chemotherapy induces nausea and vomit for some large patients. But, some chemotherapy protocol has a high indices of the incidence as observed in a combination of Anthracycline and Cyclophosphamide (AC). To prevent this symptoms, some medication can be used as Ondansetron. By other hands, the traditional acupuncture on Chinese Medicine have been used a PC6 point to avoid nausea and vomit. More recently, a transcutaneous electric nerve stimulation (TENS) also has been used for this application. Our study will test the TENS applied on PC6 point with two different frequencies (high and low) to evaluated the nausea and vomit inhibition effects.

Full description

We will enroll 84 women that being starts a chemotherapy protocol with a Anthracycline and Cyclophosphamide (AC) as a part of breast cancer treatment. All volunteers will be submitted a 30 minutes TENS prior to chemotherapy administration. Three different TENS treatment will be test: 1) placebo; 2) high frequency and 3) low frequency. The self-adhesive electrodes will be positioned in the same position for all different TENS treatment (opposite arm to the chemotherapy infusion). The eletctrodes will be positioned as follows: the first electrode at the PC6 point which is located proximal to the flexion fold of the wrist in the middle of the anterior face of the forearm, between the tendons of the long palmar and radial flexor muscles of the carpus and the second electrode at any point in the hand. After that, all volunteers will receipt a formulary to self-complete a nausea and vomit symptoms record during the next 24 hours. Number of incidence and magnitude of the symptoms will express the accumulated indices the occurrence and severity of the symptoms, as further describe in this protocol.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having breast cancer diagnosed through anatomopathological investigation;
• Indication of neoadjuvant or adjuvant chemotherapy treatment with the combination of anthracycline and cyclophosphamide associated with Ondasetron used as a routine of the Santa Rita Hospital chemotherapy service;
• Present Karnofsky score (KPS) higher than 70 points;
• Being female;
• Be between 18 and 65 years of age and be able to participate in outpatient chemotherapy.

Exclusion criteria

• Patients with breast cancer treated with chemotherapeutic regimens other than anthracycline and cyclophosphamide;
• Inability to report nausea and vomiting due to neurological changes, difficulty understanding and / or lack of caregivers that may contribute to the completion of the report;
• Be submitted to radiation therapy concomitant with chemotherapy;
• Presence of gastrointestinal and cerebral metastases;
• Presence of cardiac pacemaker;
• Presence of active skin infection in PC6;
• Nausea and vomiting caused by electrolyte disturbances or intestinal;
• Presence of intra-cranial hypertension.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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84 participants in 3 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Placebo Group: In this group the participants received TENS with frequency of 75Hz, pulse duration of 200 microseconds. The stimulation time will be for only 10s.

Treatment:

Device: Placebo Group

Low Frequency Group

Experimental group

Description:

Low Frequency Group: In this group the TENS will be adjusted with frequency of 10Hz, pulse duration of 200 microseconds. The stimulation time will be 30 minutes and the intensity will be constantly adjusted in order to keep as high as possible within the tolerance threshold of the patient.

Treatment:

Device: Low Frequency Group

High Frequency Group

Experimental group

Description:

High Frequency Group: In this group the TENS will be adjusted with frequency of 150Hz, pulse duration of 200 microseconds. The stimulation time will be 30 minutes and the intensity will be constantly adjusted in order to keep as high as possible within the tolerance threshold of the patient.

Treatment:

Device: High Frequency Group