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.
a. Patients diagnosed with colorectal cancer by pathology.
b. Age ≥ 20 years.
c. Conscious.
d. Able to communicate fluently in Mandarin and Taiwanese.
a. ECOG (Eastern Cooperative Oncology Group) ≥2 points.
b. Patients receiving intravenous nutrition.
c. Patients with pre-existing neuropathy.
d. Patients with skin wounds.
Parallel
oral magnesium ions
Dietary supplementTake 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
Combination productTake 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.
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).
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
