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

Researchers are studying whether laser auriculotherapy—a form of acupuncture that uses laser light on ear points instead of needles—can help cancer patients manage difficult side effects from chemotherapy. This study focuses on patients with gastrointestinal cancers (cancers of the digestive system) who often experience a cluster of related symptoms including anxiety, fatigue, and sleep problems during treatment.

The research protocol describes a planned clinical trial involving 62 patients who will be randomly assigned to receive either real laser auriculotherapy or a sham (placebo) treatment. Neither the patients nor researchers will know who receives which treatment, making this a rigorous double-blind study. Treatments will continue for four weeks, with specific acupuncture points on the ear being targeted that have been previously validated for these symptoms.

Researchers will measure changes in anxiety levels using the Beck Anxiety Inventory, fatigue using the Piper Fatigue Scale, and sleep quality using the Pittsburgh Sleep Quality Index. They'll also monitor vital signs like blood pressure and heart rate. The goal is to determine whether this needle-free acupuncture approach can effectively reduce these troublesome symptom clusters without additional medications.

This study is important because it addresses multiple related symptoms simultaneously rather than treating each one separately. If successful, laser auriculotherapy could offer cancer patients a safe, non-invasive option to improve their quality of life during chemotherapy. The approach may be particularly appealing for those who want to avoid additional medications or who are uncomfortable with traditional needle acupuncture. If you're considering acupuncture for chemotherapy side effects, consult with a licensed acupuncturist experienced in oncology support.

This protocol describes a randomized, double-blind, placebo-controlled trial evaluating laser auriculotherapy for neuropsychological symptom clusters in gastrointestinal cancer patients undergoing chemotherapy (n=62). Participants will be randomized to receive either active laser auriculotherapy at predetermined, validated acupuncture points or sham treatment over four weeks. Primary outcomes include anxiety assessed via Beck Anxiety Inventory (BAI), fatigue measured by Piper Fatigue Scale, and sleep quality evaluated with Pittsburgh Sleep Quality Index, with pre- and post-intervention assessments. Secondary outcomes monitor vital parameters including blood pressure, heart rate, respiratory rate, temperature, and oxygen saturation. The study design addresses the clinical challenge of managing interconnected neuropsychological symptoms rather than isolated complaints. As this is a protocol publication, no effect sizes or results are yet available. Clinical relevance lies in establishing evidence for a non-pharmacological, needle-free intervention that could be integrated into standard oncology supportive care, particularly valuable for patients experiencing polypharmacy or needle aversion during cancer treatment.