Electric Stimulation on Nausea and Vomit Chemotherapy Induced

NCT03145727 | Unknown

• 1 other identifier: TENS-NV-2017
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer Female; Acupuncture

Keywords

Chemotherapy; nausea; vomiting; transcutaneous electrical acupoint stimulation

Outcome Measures

Primary Outcomes (1)

• Cumulative index of nausea

  The 24-hour follow-up record of symptoms of nausea and vomiting will be performed using a form developed from the MASEM anti-emetic instrument (MAT), especially for the present study. This form includes a diary to record emetic events within 24 hours after the administration of chemotherapy. Thus, we will evaluate: the cumulative index of nausea and vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy.Participants will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the investigators when they return to the outpatient clinic for another round of chemotherapy.

  Cumulative index of nausea in the first 24 hours after an infusion of chemotherapy.

Secondary Outcomes (5)

• Cumulative index of episodes of vomiting

  Cumulative index of episodes of vomiting in the first 24 hours after an infusion of chemotherapy.

• Intensity of nausea symptoms

  Intensity of the symptom of nausea within the first 24 hours after infusion of chemotherapy.

• Severity of vomiting episodes

  Severity of vomiting episodes within the first 24 hours after chemotherapy infusion.

• Need for rescue antiemetic

  Need for rescue antiemetic within the first 24 hours after chemotherapy infusion

• Edmonton Symptom Assessment Scale

  At the end of 24 hours, you will be asked to complete the Edmonton Symptom Assessment Scale

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

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.

Device: Placebo Group

Low Frequency Group

EXPERIMENTAL

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.

Device: Low Frequency Group

High Frequency Group

EXPERIMENTAL

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.

Device: High Frequency Group

Interventions

Placebo Group DEVICE

In this group, the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the opposite arm of the chemotherapy infusion, but in this group the electrical stimulation will be performed just by 10 seconds and turn off for all reminiscent time of the protocol.

Placebo Group

Low Frequency Group DEVICE

In this group the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the arm opposite the chemotherapy infusion. The electrical stimulation will be continued for all time secession. The electrical pulse parameters will be setting according describe early.

Low Frequency Group

High Frequency Group DEVICE

In this group the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the arm opposite the chemotherapy infusion. The electrical stimulation will be continued for all time secession. The electrical pulse parameters will be setting according describe early.

High Frequency Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women with indication for neoadjuvant or adjuvant chemotherapy treatment with the combination of anthracycline and cyclophosphamide associated with Ondasetron
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (2)

Fabrício Edler Macagnan

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

RECRUITING

Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be blind to the TENS allocation.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: The selection of the investigated will be characterized as non-probabilistic with a convenience approach, whose patients will be included in the study sequentially until the necessary sizing has been achieved. Patients will be included sequentially for convenience (according to the inclusion and exclusion criteria) and non-probabilistic. The included individuals will be randomly randomized by Random Allocation System software in three groups, 1) placebo group; 2) High Frequency Group; 3) Low Frequency Group.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: August 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: October 30, 2018
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)