NCT07346469Not yet recruiting
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 · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 7 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07346469
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 1 Jan 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- b. Patients receiving intravenous nutrition.
Other illness
- h. Patients with renal insufficiency.
- j. Patients allergic to any of the ingredients
Other
- a. ECOG (Eastern Cooperative Oncology Group) ≥2 points.
- c. Patients with pre-existing neuropathy.
- d. Patients with skin wounds.
- e. Patients with implanted pacemakers.
- f. Patients with phenylketonuria.
- g. Patients with diarrhea.
- i. Patients with hypermagnesemia.
Who the study is looking for
- 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).
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.