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.
1 other identifier
interventional
75
1 country
1
Brief Summary
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)
- Can the magnesium intervention (oral and/or foot baths) effectively increase the serum magnesium concentration in CRC patients?
- Can the magnesium intervention alleviate or improve the severity of CIPN?
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 16, 2026
November 1, 2025
3 years
December 7, 2025
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes in magnesium concentration
Serum magnesium concentrations were monitored throughout the study. A baseline level (T0) was obtained prior to the start of the first chemotherapy cycle, followed by subsequent measurements taken before the start of each cycle from Cycle 2 to Cycle 6 (each cycle lasting 14 days).
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
The outcome measures of this study consist of two components: neuropathy symptoms and overall quality of life (QoL), both assessed using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale. 1. Neuropathy Symptoms: Evaluated using the Ntx subscale score (ranging from 0 to 44) to assess specific sensory and functional neurotoxicity. 2. Quality of Life: Measured by the FACT-G total score (ranging from 0 to 108) to assess well-being across physical, social, emotional, and functional domains. All assessments will be conducted at five specific timepoints: baseline (pre-chemotherapy, T0), at the end of Cycle 1 (T1), at the end of Cycle 4 (T2), at the end of Cycle 5 (T3), and at the end of Cycle 6 (T4); each chemotherapy cycle is defined as 14 days.
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
The sleep quality of participants was evaluated using the Verran and Snyder-Halpern (VSH) Sleep Scale. Measured via a Visual Analogue Scale (VAS), the results are reported independently across three dimensions: (1) Sleep Disturbance (assessing sleep onset latency and mid-sleep awakenings), (2) Sleep Effectiveness (assessing sleep quality and depth), and (3) Sleep Supplementation (assessing daytime napping and feelings upon awakening). All assessments were conducted at five specific timepoints: baseline (pre-chemotherapy, T0), at the end of Cycle 1 (T1), at the end of Cycle 4 (T2), at the end of Cycle 5 (T3), and at the end of Cycle 6 (T4); each chemotherapy cycle was fixed at a duration of 14 days.
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.
Study Arms (3)
Placebo Comparator
NO INTERVENTIONRoutine care without interventional measures
Experimental Group 1 (oral administration of magnesium ions)
EXPERIMENTALTake one packet of oral magnesium ions (400mg) daily
Experimental Group 2 (oral administration of magnesium ions + foot soak in magnesium ion solution)
EXPERIMENTALoral magnesium ions (400 mg) daily, and soak your feet in warm water containing soapberry magnesium ions
Interventions
Take one packet of oral magnesium ions (400 mg) daily for 3 months until the end of the 6th chemotherapy session.
Take one packet of oral magnesium ions (400 mg) daily, and soak your feet in warm water containing soapberry magnesium ions for 10-15 minutes, continuing for 3 months until the end of the 6th chemotherapy session.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin District, 807378, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2025
First Posted
January 16, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
January 16, 2026
Record last verified: 2025-11