Breast Cancer FemaleTENS-NVNCT03145727
Electric Stimulation on Nausea and Vomit Chemotherapy Induced
A study testing Low Frequency Group and High Frequency Group in people with Breast Cancer Female and Acupuncture, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Female, Acupuncture
- What is being tested?
- Low Frequency Group and High Frequency Group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Aug 2017to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Fabrício Edler Macagnan
Porto Alegre, Rio Grande do Sul, 90050-170
Fabrício Macagnan, PhD, +55 (51) 3309.8876, fabriciom@ufcspa.edu.br
- Recruiting
Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul
Elizete Keitel, Dr, +55 (51) 3214.8571, cep@santacasa.tche.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Female, Acupuncture
- Being tested
- Placebo Group, Low Frequency Group, High Frequency Group
- Keywords
- Chemotherapy, nausea, vomiting, transcutaneous electrical acupoint stimulation
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo GroupDevice
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.
Low Frequency GroupDevice
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 GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: High Frequency Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cumulative index of nausea in the first 24 hours after an infusion of chemotherapy.
Secondary outcomes (5)
Cumulative index of episodes of vomiting
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.
Measured: Cumulative index of episodes of vomiting in the first 24 hours after an infusion of chemotherapy.
Intensity of nausea symptoms
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.
Measured: Intensity of the symptom of nausea within the first 24 hours after infusion of chemotherapy.
Severity of vomiting episodes
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.
Measured: Severity of vomiting episodes within the first 24 hours after chemotherapy infusion.
Need for rescue antiemetic
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.
Measured: Need for rescue antiemetic within the first 24 hours after chemotherapy infusion
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.
Measured: At the end of 24 hours, you will be asked to complete the Edmonton Symptom Assessment Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Aug 2017
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Responsible party
- Principal investigator, Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145727
- Sponsor's protocol ID
- TENS-NV-2017
- Acronym
- TENS-NV
- Status last verified
- Aug 2017
- First submitted
- 5 May 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electric Nerve Stimulation Effects on Nausea and Vomit Chemotherapy-induced
- ClinicalTrials.gov ID
- NCT03145727
- Acronym / sponsor ID
- TENS-NV / TENS-NV-2017
- Conditions
- Breast Cancer Female, Acupuncture
- Keywords
- Chemotherapy, nausea, vomiting, transcutaneous electrical acupoint stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Device: Placebo GroupPlacebo 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. |
| Low Frequency Group | Experimental | Device: Low Frequency GroupLow 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. |
| High Frequency Group | Experimental | Device: High Frequency GroupHigh 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo GroupIn 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. | Device | Placebo Group |
| Low Frequency GroupIn 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. | Device | Low Frequency Group |
| High Frequency GroupIn 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. | Device | High Frequency Group |
Primary outcome
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.
5 secondary outcomes
Cumulative index of episodes of vomiting
Time frame: 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.
Severity of vomiting episodes
Time frame: 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
Edmonton Symptom Assessment Scale
Time frame: At the end of 24 hours, you will be asked to complete the Edmonton Symptom Assessment Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Frequency Group and High Frequency Group in people with Breast Cancer Female and Acupuncture, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative index of nausea (time frame: Cumulative index of nausea in the first 24 hours after an infusion of chemotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.