Chemotherapy for colorectal cancer (CRC) is frequently complicated by chemotherapy-induced peripheral neuropathy (CIPN) and impaired sleep quality, significantly impacting patient quality of life. Low magnesium levels have been implicated in peripheral nerve dysfunction. This interventional study aims to investigate the effects of magnesium supplementation on serum magnesium concentration, CIPN severity, and sleep quality in CRC patients undergoing chemotherapy. Study Design and Methods This is a prospective, parallel-group, randomized controlled trial (RCT) utilizing a longitudinal design. Participants (CRC patients undergoing chemotherapy) will be randomly allocated to one of three groups: * Experimental Group 1: Oral magnesium (400mg) supplementation. * Experimental Group 2: Oral magnesium (400mg}) supplementation and magnesium solution foot baths. * Control Group: Standard care. Measurements will be collected using structured questionnaires and blood samples during each chemotherapy cycle. The primary outcomes will be assessed using: * Serum Magnesium Concentration * CIPN Severity: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-neurotoxicity (FACT/GOG-Ntx) scale. * Sleep Quality: Verran and Snyder-Halpern Sleep Scale (VSH). Primary Research Questions (Hypotheses) 1. Can the magnesium intervention (oral and/or foot baths) effectively increase the serum magnesium concentration in CRC patients? 2. Can the magnesium intervention alleviate or improve the severity of CIPN? 3. Can the magnesium intervention improve the sleep quality of CRC patients during chemotherapy? The intervention groups will be compared against the control group to determine if the magnesium interventions lead to superior improvement in the measured outcomes.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Changes in magnesium concentration
Timeframe: Measurements were taken at baseline (prior to the first chemotherapy cycle, T0) and subsequently before the start of chemotherapy Cycles 2, 3, 4, 5, and 6; the duration of each cycle was fixed at 14 days.
Neuropathic symptoms and quality of life assessment
Timeframe: Measurements were taken at baseline (prior to chemotherapy, T0) and subsequently at the end of chemotherapy Cycles 1 (T1), 4 (T2), 5 (T3), and 6 (T4); the duration of each cycle was 14 days.
Sleep quality assessment
Timeframe: Measurements were taken at baseline (prior to chemotherapy, T0) and subsequently at the end of chemotherapy Cycles 1 (T1), 4 (T2), 5 (T3), and 6 (T4); the duration of each cycle was 14 days.