Clinical trial NCT03145727: Electric Stimulation on Nausea and Vomit Chemotherapy Induced
Official title: Transcutaneous Electric Nerve Stimulation Effects on Nausea and Vomit Chemotherapy-induced
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Acupuncture
Keywords: Chemotherapy
nausea
vomiting
transcutaneous electrical acupoint stimulation
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Irmandade Santa Casa de Misericórdia de Porto Alegre
First posted: 2017-05-09
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative index of nausea
timeFrame: Cumulative index of nausea in the first 24 hours after an infusion of chemotherapy.
Secondary outcomes:
measure: Cumulative index of episodes of vomiting
timeFrame: Cumulative index of episodes of vomiting in the first 24 hours after an infusion of chemotherapy.
measure: Intensity of nausea symptoms
timeFrame: Intensity of the symptom of nausea within the first 24 hours after infusion of chemotherapy.
measure: Severity of vomiting episodes
timeFrame: Severity of vomiting episodes within the first 24 hours after chemotherapy infusion.
measure: Need for rescue antiemetic
timeFrame: Need for rescue antiemetic within the first 24 hours after chemotherapy infusion
measure: Edmonton Symptom Assessment Scale
timeFrame: At the end of 24 hours, you will be asked to complete the Edmonton Symptom Assessment Scale
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Fabrício Edler Macagnan
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande do Sul
Study officials:
References: