Effect of laser application to the ear for pain relief in patients with advanced cancer

INTERVENTION: This is a two‐arm, randomized, double‐blind clinical trial to be conducted at the Barretos Cancer Hospital (Fundação Pio XII). The sample consists of 34 participants, with 17 assigned to the control group and 17 to the intervention group. Randomization will be performed by the principal investigator using the Research Electronic Data Capture platform, based on the Edmonton Symptom Assessment System‐pain variable. The evaluating researcher will be blinded to the participant's group assignment and will be responsible for pain assessment. Participants will be blinded as to whether they are receiving placebo treatment or laser pain treatment; both groups will undergo laser application, with the distinction between the intervention and control groups lying in the specific auricular points targeted. Intervention protocol: The intervention group will receive laser therapy at the following acupoints: Shenmen, Vagus Nerve, Heart, Kidney, and Lung. The "Therapy" (EC version) device will be used, featuring a red laser with a 660‐nanometer wavelength, 100‐microwatt power, and a dose of 3 Joules per point, with a total application time of approximately 3 minutes. The control group will receive laser application at placebo auricular points: elbow, eye, hand, external ear, and mouth—ensuring no interaction with specific pain‐treatment points. The same "Therapy" (EC version) device will be used, with a red laser, 660‐nanometer wavelength, 100‐microwatt power, and a dose of 3 Joules per point, with a total application time of approximately 3 minutes. To ensure eye protection, both researchers and participants will wear protective eyewear that blocks red radiation. Application procedure: At baseline (time zero), the evaluating researcher will invite the patient to participate in the study; following the signing of the informed consent form, the participant will be registered in the Research Electronic Data Capture system and randomly assigned to either the control group or the intervention group. After the researcher performing the laser intervention cleans the participant's auricular region with 70% alcohol, the red laser will be applied to the points determined by the assigned group, and the evaluating researcher will conduct re‐evaluations 15 minutes and 24 hours later CONDITION: complementary therapies; cancer‐related pain ; Oncology H02.403.429.515 PRIMARY OUTCOME: The expected primary outcome is a reduction in the intensity of cancer pain, as assessed by the ESAS‐pain scale. Its effectiveness will be verified by comparing pain intensity between the intervention group and the control group at pre‐intervention, fifteen minutes after application, and twenty‐four hours after the protocol SECONDARY OUTCOME: Reduction in the need for pharmacological analgesia; reduction in the frequency of opioid use, assessed based on the number of opioid doses requested by the patient in the 24 hours following the intervention compared to the 24 hours preceding the protocol; evaluation of the auricular laser acupuncture technique in patients with advanced cancer, observing whether the intervention is well‐tolerated and safe for this vulnerable population; assessment of the patient's subjective report regarding well‐being and perception following the therapy, at 15 minutes and 24 hours post‐application INCLUSION CRITERIA: Patients admitted to the adult clinical oncology inpatient unit; Clinical diagnosis of advanced cancer; Aged eighteen years or older; Reporting a minimum pain score of three on the ESAS pain scale, related to the disease and cancer treatment; KPS score greater than or equal to thirty percent and responsive; Patients of both genders