Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Peripheral Neuropathy (CIPN) | — | UNRESOLVED | — |
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Quality of Life (QOL) | — | UNRESOLVED | — |
| Sleep Quality | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral magnesium ions | Dietary Supplement | — | UNRESOLVED |
| oral magnesium ions and warm water with Gu Bao Sapindus mukorossi magnesium ion solution | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Placebo Comparator
- description
- Routine care without interventional measures
- type
- EXPERIMENTAL
- label
- Experimental Group 1 (oral administration of magnesium ions)
- description
- Take one packet of oral magnesium ions (400mg) daily
- interventionNames
- Dietary Supplement: oral magnesium ions
- type
- EXPERIMENTAL
- label
- Experimental Group 2 (oral administration of magnesium ions + foot soak in magnesium ion solution)
- description
- oral magnesium ions (400 mg) daily, and soak your feet in warm water containing soapberry magnesium ions
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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
References
Publications (0)
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