Exploring the Effects of Magnesium Ions on Peripheral Neuropathy, Serum Magnesium Ion Concentration,Sleep Quality, and Quality of Life in Patients With Colorectal Cancer Receiving Chemotherapy.
Starting soon · Not applicable
Conditions studied: Colorectal Cancer (CRC), Chemotherapy Induced Peripheral Neuropathy (CIPN), Sleep Quality, Quality of Life (QOL)
In brief
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.
Key facts
- Study ID
- NCT07346469
- Run by
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- People needed
- 75
- Starts
- 2026-01-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-01-16
Who can join
Age: 20 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- a. Patients diagnosed with colorectal cancer by pathology.
- b. Age ≥ 20 years.
- c. Conscious.
- d. Able to communicate fluently in Mandarin and Taiwanese.
- e. Patients who have received or are expected to begin chemotherapy (Oxaliplatin).
You may not qualify if…
- a. ECOG (Eastern Cooperative Oncology Group) ≥2 points.
- b. Patients receiving intravenous nutrition.
- c. Patients with pre-existing neuropathy.
- d. Patients with skin wounds.
- e. Patients with implanted pacemakers.
- f. Patients with phenylketonuria.
- g. Patients with diarrhea.
- h. Patients with renal insufficiency.
- i. Patients with hypermagnesemia.
- j. Patients allergic to any of the ingredients
Where it is running
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Sanmin District, Taiwan
Full record on ClinicalTrials.gov
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