NCT07346469|Not 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.

Kaohsiung Medical University Chung-Ho Memorial Hospital ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

KMUHIRB-F(I)-20250330

Study Type

interventional

Estimated enrollment

Locations

1 country

Sites

Timeline

Study Start

January 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 31, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: not yet recruiting
Estimated enrollment: 75 participants
Study completion date: December 31, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 7, 2025
Actual (reported)
Study Start
January 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
First Posted
January 16, 2026
Actual (reported)
Primary Completion
December 31, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: January 16, 2026
Status Verified: November 2025
Last Update Submitted: January 7, 2026

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)Colorectal Cancer (CRC)Quality of Life (QOL)Sleep Quality

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 Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Purpose

OTHER

Intervention Model

PARALLEL

Model Details: This study employed an experimental design. Experimental group 1 (25 participants) received one packet of oral magnesium ions daily, while experimental group 2 (25 participants) received one packet of oral magnesium ions daily and a foot bath device with magnesium ion solution added for warm water soaking for 10-15 minutes daily. The control group (25 participants) received no interventional measures. The treatment lasted 3-6 months, and changes in blood magnesium ion concentration were measured during routine blood tests at each hospital admission for chemotherapy (data collected a total of 6 times). Research tools included a structured questionnaire: a basic information questionnaire (17 questions), a functional assessment of cancer treatment/gynecologic oncology group - neurotoxicity (FACT/GOG-Ntx) (38 questions), and the Verran and Snyder-Halpern Sleep Scale (VSH) (15 questions), requiring approximately 25 minutes of study time.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Study Record Dates

First Submitted

December 7, 2025

First Posted

January 16, 2026

Study Start

January 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 31, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

January 16, 2026

Record last verified: 2025-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier

NCT07346469

Data provider

ClinicalTrials.gov

Source updated

2026-01-16

Normalization version

ctgov-legacy-1

Source retrieved: 2026-10-25 22:29:47 UTC

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.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (3)

Placebo Comparator

Experimental Group 1 (oral administration of magnesium ions)

Experimental Group 2 (oral administration of magnesium ions + foot soak in magnesium ion solution)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (3)

Placebo Comparator

Experimental Group 1 (oral administration of magnesium ions)

Experimental Group 2 (oral administration of magnesium ions + foot soak in magnesium ion solution)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations