Effect of Laser Auriculotherapy on Managing Neuropsychological Symptom Clusters in Patients With Gastrointestinal Neoplasms: Protocol for a Randomized Clinical Trial.

Background: Individuals with gastrointestinal neoplasms undergoing chemotherapy may develop symptoms related to anxiety, fatigue, and sleep disturbances, which are components of neuropsychological symptom clusters. Among non-pharmacological strategies that may aid in symptom management, laser auriculotherapy-a modality of acupuncture-has emerged as a promising approach in symptom management studies. Objective: This study aims to present a research protocol designed to evaluate the effect of laser auriculotherapy in reducing neuropsychological symptom clusters associated with anxiety, fatigue, and sleep disturbances in patients with gastrointestinal neoplasms undergoing chemotherapy. Methods: A randomized, controlled, double-blind clinical trial will be conducted, involving 62 patients recruited with gastrointestinal cancer initiating chemotherapy treatment at a University Hospital that is a reference in the treatment of cancer patients. Participants will be randomly assigned to one of two groups: (1) Experimental Group: laser auriculotherapy applied to predetermined and validated acupuncture points, or (2) Control Group: Sham laser auriculotherapy (placebo). Patients will be followed for 4 weeks. Two important moments will be considered to evaluate the results of the intervention (Pre-intervention and Post-intervention). The primary outcomes will include the reduction in anxiety scores measured by the BAI, the reduction in fatigue scores measured by the Piper Fatigue Scale, and the reduction in sleep scores measured by the Pittsburgh Sleep Quality Index. The secondary outcome will evaluate changes in vital parameters ((blood pressure, heart rate, respiratory rate, temperature and oxygen saturation). Discussion: The study aims to contribute to the reduction of the cluster of neuropsychological symptoms in patients with gastrointestinal cancer, using a non-pharmacological strategy that can be inserted into the clinical practice of health professionals and oncology reference centers.