Drug therapy
Conditions
Interventions
The study is based on a sample of 105 independent auriculotherapy sessions. Experimental group: 58 trials with the effective treatment of auriculotherapy and use of standardized antiemetics in the ins
Other
E02.190.204
Sponsors
Universidade Federal Fluminense
Instituto Nacional de Câncer José Alencar Gomes da Silva
Eligibility
Sex/Gender
Male
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Adult men aged 18 to 59 years diagnosed with cancer, undergoing chemotherapy from the second cycle with protocols with the following drugs with a high degree of emetogenicity: Combination AC (Doxorubicin + Cyclophosphamide), Carboplatin (AUC greater than or equal to 4mg / m²), Cisplatin, Cyclophosphamide (greater than or equal to 1500mg / m²), Dacarbazine, Doxorubicin (greater than or equal to 60mg / m²), Epirubicin (greater than 90mg / m²) and Ifosfamide (greater than or equal to 2g / m²). In addition, patients with previous experience of nausea and vomiting regarding previous chemotherapy and presentation of the KPS (Karnofsky Performance Status) scale above 70%.
Exclusion criteria
Exclusion criteria: Adult men with cognitive deficit described in medical records; with previous gastrointestinal diseases or previous anti-ulcer treatment; cancer located in the stomach, due to the interference of the disease in the control of nausea and vomiting; neoplasms located in the Central Nervous System (CNS), as they can interfere in the center of vomiting; previous history of allergy to antiallergic micropose patch or any other patch currently available; patients who started outpatient chemotherapy but were hospitalized, for some reason, and continued inpatient chemotherapy, as they receive intravenous antiemetic medication every 8 hours and prolonged venous hydration, which could be a bias for the research. And previous history of use of antiemetics that are not standardized by the hospital.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: in the number of events and in the intensity of nausea and vomiting, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) scale; National Cancer Institute (NCI) - v4.03: 2010, from the first seven days after chemotherapy.;Outcome found 1: in the global analysis of the seven days evaluated, the participants in the intervention group had a significantly better state of nausea (p value = 0.042 - Mann Whitney test) than the participants treated with placebo. And there was no significant difference in the global vomiting score of the participants in both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: Anxiety improvement, assessed through the participant's perception of the first seven days after chemotherapy.;Outcome found 2: Anxiety improvement was reported only in three cases in the control group (6.4%) and in 21 cases (36.2%) in the intervention group. It is estimated that the chance of a patient who has undergone auriculotherapy treatment (intervention group) to improve anxiety is 8.3 times the chance of a patient who has not. | — |
Countries
Brazil
Contacts
Public ContactCarolina Contim
Instituto Nacional de Câncer José Alencar Gomes da Silva
Outcome results
None listed