Transcutaneous Electric Nerve Stimulation Effects on Nausea and Vomit Chemotherapy-induced
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Cumulative index of nausea
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participant will be blind to the TENS allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Placebo Group (Device)
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.
干预措施: Low Frequency Group (Device)
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.
干预措施: High Frequency Group (Device)
结局指标
主要结局
Cumulative index of nausea
时间窗: 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.
次要结局
- 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)
研究者
Fabrício Edler Macagnan
PhD
Federal University of Health Science of Porto Alegre