Use of laser Auriculotherapy in Cancer patients in palliative Chemotherapy

INTERVENTION: This is a parallel randomized clinical trial, open, uni‐blind, with follow‐up of patients with advanced breast cancer using palliative chemotherapy, in four groups: experiment group 1 (EG1) will receive the intervention of laser auriculotherapy, group experiment 2 (GE2) will receive the relaxation experiment with guided imagery, simulated auriculotherapy group (GS) will receive auriculotherapy without laser emission, and control group (GC) will not receive any intervention. A total of 160 people who meet the eligibility criteria will be probabilistically allocated to one or the other group using a table of random numbers. Participants in the experiment 1 group and the simulated auriculotherapy group will be blinded to each other. Experimental group 1 ‐ laser auriculotherapy ‐ In the first session, the 40 participants with advanced breast cancer who will start treatment with palliative chemotherapy will be characterized through the application of a socioeconomic and clinical questionnaire prepared by the authors, evaluated in relation to anxiety through of the State‐Trait Anxiety Inventory instrument (STAI T‐E) and evaluated in relation to quality of life related to health and fatigue using the QLQ C‐30 and FACT‐F instrument. The IDATE T‐E, QLQ C‐30 and FACT‐F instruments will be applied before the first session, before the sixth session and one week after the tenth session (weeks 1, 6 and 11). Ten sessions of auriculotherapy will be offered, once a week, using the low intensity laser, Therapy ilib from DMC Equipamentos Ltda, at a power of two joules (2J) per acupoint, for 20 seconds at each auricular point. Eleven fixed auricular points will be stimulated by the laser: Shen Men, Kidney, Autonomic Nervous System, brain stem, spleen, anterior anxiety, diaphragm, muscle re CONDITION: Cancer; Antineoplastic E02.760.666 PRIMARY OUTCOME: It is intended, as the primary outcome of this research, the reduction of side effects from palliative chemotherapy and improvement in the health‐related quality of life score of patients with stage III or IV advanced breast cancer. These will be measured by the “QLQ‐C30” questionnaire, in the group of patients who underwent the laser auriculotherapy technique and/or guided image relaxation. SECONDARY OUTCOME: It is intended, as a secondary outcome, improvement in fatigue indices, measured by the FACT‐F questionnaires (version 4), in the group of patients with stage III or IV advanced breast cancer using palliative chemotherapy, who underwent laser auriculotherapy technique and/or image relaxation guided tour. It is intended, as a secondary outcome, the decrease in anxiety levels, measured through the AGE‐TRAIT‐STATE questionnaire in the group of patients with stage III or IV advanced breast cancer undergoing palliative chemotherapy, who underwent the technique of auriculotherapy with laser and /or guided image relaxation. INCLUSION CRITERIA: Age 18 years or over, of both sexes; having been diagnosed with advanced breast cancer and starting palliative chemotherapy treatment at the SUS clinical oncology clinic at the Erasto Gaertner Hospital; patients diagnosed with stage III or IV advanced breast cancer, regardless of the chemotherapy plan (number of sessions, adverse effects, duration of treatment)