Nausea
Conditions
Interventions
This is a two-arm, single-blind, randomized controlled clinical trial. Experimental group (auricular acupuncture): 50 cancer patients reporting nausea and/or vomiting induced by antineoplastic chemoth
Jiaogan (AH6a) sympathetic nervous system
Wèi (CO4) stomach
Pí (CO13) spleen
Gän (CO12) liver
Pízhìxià (AT4) subcortex
and bënmén (C03) cardia, according to the standard Chinese auricular map. The seeds will remain fixed in the ear for seven days and patients will be instructed to stimulate them at home during this pe
Sponsors
Universidade Federal de Alfenas (UNIFAL-MG)
Universidade Federal de Alfenas (UNIFAL-MG)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 or over, regardless of gender; have a confirmed diagnosis of cancer, of any histological type and staging of the disease; during the data collection of the study be undergoing chemotherapy for adjuvant, neoadjuvant or palliative purposes; report the presence of nausea and/or vomiting; have time available to participate in the auricular acupuncture sessions; have a performance status equal to or less than three according to the Eastern Cooperative Oncology Group Performance Status
Exclusion criteria
Exclusion criteria: Inflammations, infections, ulcerations or deformities of the ear; use of hearing aids; confirmed or suspected pregnancy; allergy to microporous tape
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect to find an improvement in the incidence, frequency, severity and duration of chemotherapy-induced nausea and vomiting, assessed using the Morrow Assessment Nausea and Emesis Scale, which uses an ordinal qualitative scale to measure these parameters. It is expected that there will be a statistically significant reduction, considering a significance level with a p-value of less than 0.05 for the scale variables in relation to the groups and times. Data will be collected immediately before the intervention, one week after the last week of the intervention and two weeks after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect to see an improvement in health-related quality of life, assessed using the Functional Assessment of Cancer Therapy, General, FACT-G, version 4. It is assessed using a five-point Likert scale, with possible values for each of the subscales ranging from 0 to 28, with the exception of the Emotional Well-Being subscale, where the score can range from 0 to 24. The total value is obtained by adding up the values for each subscale and can range from 0 to 108, so that the higher the resulting value, the higher the level of quality of life. There is no cut-off point on the scale to measure an improvement in health-related quality of life, so a reduction in these scores can be considered a clinical improvement, considering a statistically significant difference, with a p-value of less than 0.05. Data will be collected immediately before the intervention, one week after the last week of the intervention and two weeks after the intervention ;To evaluate the adverse reactions resulting from the interventions applied and their intensity, using an instrument adapted from a model previously used in a doctoral thesis on the effects of auricular acupuncture associated with wind therapy on chronic pain in people with musculoskeletal disorders in the spine. The patient will point out the possible symptoms and adverse reactions that will arise during the interventions and these will be classified on an 11-point likert scale, where zero means no discomfort and ten unbearable. Each adverse reaction will be processed as a categorical variable and its intensity as a continuous variable. This assessment will only take place during the final evaluation | — |
Countries
Brazil
Contacts
Public ContactEliza Paiva
Universidade Federal de Alfenas (UNIFAL-MG)
Outcome results
None listed