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

August 21, 2017 updated by: Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre

Transcutaneous Electric Nerve Stimulation Effects on Nausea and Vomit Chemotherapy-induced

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
        • Recruiting
        • Fabricio Edler Macagnan
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Recruiting
        • Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Group
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
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.
Experimental: Low Frequency Group
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
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.
Experimental: High Frequency Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cumulative index of nausea
Time Frame: Cumulative index of nausea in the first 24 hours after an infusion of chemotherapy.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative index of episodes of vomiting
Time Frame: Cumulative index of episodes of vomiting in the first 24 hours after an infusion of chemotherapy.
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 episodes of vomiting in the first 24 hours after an infusion of chemotherapy.
Intensity of nausea symptoms
Time Frame: Intensity of the symptom of nausea within the first 24 hours after infusion of chemotherapy.
As for the intensity of nausea, a Visual Analog Scale will be used to help measure the intensity of each patient. The instrument will question the patient about the degree of nausea and it will provide an auto report with a note that can vary from 0 to 10, with note 0 representing absence of the symptom while note 10 represents the most intense sensation experienced by the patient . 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.
Intensity of the symptom of nausea within the first 24 hours after infusion of chemotherapy.
Severity of vomiting episodes
Time Frame: Severity of vomiting episodes within the first 24 hours after chemotherapy infusion.
The severity assessment of vomiting episodes includes a diary to record the number of episodes of vomiting, which may be small, medium or large. Thus, we will assess the severity of vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy. Participants will be instructed to complete the instrument and take the questionnaire home, bringing it back to the investigators. When they return to the clinic for another round of chemotherapy.
Severity of vomiting episodes within the first 24 hours after chemotherapy infusion.
Need for rescue antiemetic
Time Frame: Need for rescue antiemetic within the first 24 hours after chemotherapy infusion
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 emetic high-grade chemotherapy, the volume of vomiting in each episode and the need for rescue antiemetics will also be recorded. Will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the researchers when they return to the clinic for their second course of chemotherapy.
Need for rescue antiemetic within the first 24 hours after chemotherapy infusion
Edmonton Symptom Assessment Scale
Time Frame: At the end of 24 hours, you will be asked to complete the Edmonton Symptom Assessment Scale
At home and at the end of 24 hours, will be asked to fill in the Edmonton Symptom Assessment Scale where symptoms of pain, tiredness, drowsiness, appetite, nausea, shortness of breath, depression, anxiety and well-being will be evaluated, Based on the Brazilian Consensus on Nausea and Vomiting. It is a scale where the patient provides an auto-report with a note that can vary from 0 to 10, with note 0 representing absence of the symptom while note 10 represents the most intense sensation experienced by the patient.
At the end of 24 hours, you will be asked to complete the Edmonton Symptom Assessment Scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Health Science of Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Irmandade Santa Casa de Misericórdia de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TENS-NV-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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