Cancer Pain
Conditions
Interventions
This is a randomized clinical study conducted in two phases: Phase 1 — a pilot study to estimate the final sample size for the main clinical trial
and Phase 2 — a randomized, controlled, parallel, open-label clinical trial. Both phases will follow the same study protocol. A total of 174 women with breast cancer who meet the eligibility criteria
Sponsors
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Be 18 years of age or older; be a woman; be undergoing treatment for breast cancer, regardless of the type of oncological therapy; have undergone surgery for the disease prior to the study, at least three months and at most 10 years earlier; report pain that began after surgery, with an intensity greater than or equal to 4 points on the Numeric Rating Scale (NRS)
Exclusion criteria
Exclusion criteria: Present metastasis; have cognitive impairment that precludes responding to the study instruments; be using high doses of anticoagulants; have undergone auricular acupuncture treatment for cancer-related pain within the three months prior to the study; present ear piercings near the auricular points to be used in the study; report a history of allergy to needles, seeds, or microporous tape; present lesions, inflammation, deformity, or tattoos on the ear; or use a hearing aid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer pain intensity: assessed using the Brief Pain Inventory, short form. The instrument will be administered before (baseline) and after the intervention (final assessment), as well as 15 days after the final assessment. A reduction in oncological pain intensity is expected following treatment with auricular acupuncture. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life: will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Quality of Life Questionnaire Breast Cancer–23 (EORTC QLQ-BR23). The instruments will be administered before the intervention (baseline), after the intervention (final assessment), and 15 days after the final assessment. An improvement in quality of life is expected following treatment with auricular acupuncture.;Participant satisfaction and experience with auricular acupuncture treatment: will be assessed after the completion of the intervention (final assessment). This variable will be evaluated only for participants in the groups receiving auricular acupuncture treatment. It is expected that participants who undergo auricular acupuncture will report a high level of satisfaction with the intervention.;Use of medications for pain relief and management: assessed using item seven of the Brief Pain Inventory (BPI-SF), which evaluates the medications taken for pain. The instrument will be administered before the intervention (baseline), after the intervention (final assessment), and 15 days following the final assessment. For participants undergoing auricular acupuncture, a reduction in the use of medications for pain relief is expected.;Vital signs (heart rate, blood pressure, and respiratory rate): Heart rate will be measured using a portable digital pulse oximeter to record beats per minute. Respiratory rate will be assessed by observing the participant’s thoracic or abdominal movements over one minute. Blood pressure will be measured using a digital sphygmomanometer. These vital signs will be recorded after the participant has remained at rest for 10 minutes, prior to the assessments. For participants undergoing auricular acupuncture who exhibit altered vital signs, it is expected that these signs will return to normal values following the intervention. | — |
Countries
BR
Contacts
Public ContactLudmila Ruela
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed