Electric Stimulation on Nausea and Vomit Chemotherapy Induced
关键词
抽象
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.
日期
| 最后验证: | 07/31/2017 |
| 首次提交: | 05/04/2017 |
| 提交的预估入学人数: | 05/07/2017 |
| 首次发布: | 05/08/2017 |
| 上次提交的更新: | 08/20/2017 |
| 最近更新发布: | 08/21/2017 |
| 实际学习开始日期: | 07/31/2017 |
| 预计主要完成日期: | 12/29/2017 |
| 预计完成日期: | 10/29/2018 |
状况或疾病
干预/治疗
Device: Placebo Group
Device: Low Frequency Group
Device: High Frequency Group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. Cumulative index of nausea [Cumulative index of nausea in the first 24 hours after an infusion of chemotherapy.]
次要成果指标
1. Cumulative index of episodes of vomiting [Cumulative index of episodes of vomiting in the first 24 hours after an infusion of chemotherapy.]
2. Intensity of nausea symptoms [Intensity of the symptom of nausea within the first 24 hours after infusion of chemotherapy.]
3. Severity of vomiting episodes [Severity of vomiting episodes within the first 24 hours after chemotherapy infusion.]
4. Need for rescue antiemetic [Need for rescue antiemetic within the first 24 hours after chemotherapy infusion]
5. Edmonton Symptom Assessment Scale [At the end of 24 hours, you will be asked to complete the Edmonton Symptom Assessment Scale]
