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.

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

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.

Eligibility

Primary outcome measure(s)

• Changes in magnesium concentration — 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.
  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).
• Neuropathic symptoms and quality of life assessment — 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.
  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.
• Sleep quality assessment — 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.
  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.

Trial sites (1)

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