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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.

NCT07346469 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-01-16

No results posted yet for this study

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)

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

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

Interventions

DIETARY_SUPPLEMENT

oral magnesium ions

Take one packet of oral magnesium ions (400 mg) daily for 3 months until the end of the 6th chemotherapy session.

COMBINATION_PRODUCT

oral magnesium ions and warm water with Gu Bao Sapindus mukorossi magnesium ion solution

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.

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346469 on ClinicalTrials.gov