BACKGROUND
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of cancer treatment with neurotoxic chemotherapeutic agents, including taxanes, platinum-based compounds, and vinca alkaloids. It is characterized by sensory and motor dysfunctions, such as numbness, tingling, pain, and reduced coordination, often significantly impacting patients’ quality of life and treatment adherence.[1] The incidence of CIPN varies widely, affecting approximately 30–70% of patients depending on the type of chemotherapy used and the cumulative dose.[2]
The pathophysiology of CIPN involves multifactorial mechanisms, including mitochondrial dysfunction, oxidative stress, and direct damage to peripheral nerves caused by chemotherapeutic agents. These changes lead to alterations in sensory and motor nerve conduction, resulting in symptoms that may persist long after chemotherapy cessation.[3] While pharmacological interventions, such as gabapentinoids and antidepressants, are frequently employed for CIPN management, their efficacy remains limited, and side effects can compromise patient compliance.[4]
Non-pharmacological interventions have garnered interest as adjunct therapies for managing CIPN. Among these, Epsom salt (magnesium sulfate) has been explored for its potential neuroprotective effects. Magnesium sulfate is believed to exert its benefits by reducing neuroinflammation, enhancing circulation, and mitigating oxidative stress, which are key contributors to CIPN.[5,6] Epsom salt foot baths offer a simple, cost-effective, and noninvasive method to deliver magnesium transdermally, potentially alleviating symptoms and delaying CIPN onset.[7]
Previous studies have demonstrated the efficacy of magnesium supplementation in various neuropathic conditions, suggesting its potential role in reducing chemotherapy-induced nerve damage.[8] However, robust clinical evidence supporting the use of Epsom salt foot baths in CIPN prevention and management is limited. This study was designed to address this gap by evaluating the efficacy of Epsom salt foot baths in preventing and alleviating CIPN symptoms among cancer patients undergoing neurotoxic chemotherapy.
MATERIAL AND METHOD
Study design
This study was a randomized clinical trial conducted to assess the efficacy of Epsom salt foot baths in preventing or delaying chemotherapy-induced peripheral neuropathy (CIPN) in asymptomatic cancer patients and alleviating symptoms in symptomatic cases. The trial adhered to ethical standards, and prior approval was obtained from the Institutional Ethics Committee (IEC) on June 25, 2018. It was registered in the Clinical Trials Registry of India (CTRI/2021/03/031867).
Study setting and duration
The study was carried out at A.V.B.R. Hospital, Sawangi (Meghe), Wardha, India, a tertiary care center under the Datta Meghe Institute of Higher Education and Research. The study spanned over two years, from patient recruitment to data analysis.
Study population
The study included cancer patients undergoing chemotherapy with neurotoxic drugs. Patients were categorized into two main groups based on CIPN status: asymptomatic (no prior symptoms of CIPN) and symptomatic (patients experiencing moderate CIPN symptoms).
Inclusion and exclusion criteria
Inclusion criteria
- Asymptomatic Group: Cancer patients indicated for chemotherapy with neurotoxic drugs and without CIPN symptoms.
- Symptomatic Group: Patients experiencing moderate CIPN symptoms, such as pain, numbness, or burning sensations in the lower extremities, after a minimum of two chemotherapy cycles (graded as moderate CIPN per NCI-CTCAE criteria).
Exclusion criteria
- Patients with preexisting conditions like diabetes or peripheral neuropathy due to other causes.
- Terminally ill cancer patients.
Sample size and randomization
The total sample size was 104 patients, divided equally into asymptomatic and symptomatic groups (n = 52 each). Each group was further randomized into experimental (n = 26) and control (n = 26) arms using a computer-generated randomization sequence. This ensured balanced allocation and minimized selection bias.
Intervention
Patients in the experimental group received a daily Epsom salt foot bath intervention alongside standardized hospital care. The foot baths were administered for 20 minutes daily using a standardized solution of Epsom salt dissolved in warm water at a temperature of 38–40°C. Control groups received only standardized hospital care without the intervention.
Data collection and assessment
Baseline data were collected for all participants, including demographic details, cancer diagnosis, type of chemotherapy drug, and CIPN status. Assessments were conducted at three time points: baseline, second follow-up (after two cycles of chemotherapy), and final follow-up (end-line observation).
CIPN severity was evaluated using the NCI-CTCAE grading system, and quality of life (QoL) was measured using a validated tool tailored for cancer patients. For symptomatic patients, sensory and motor symptoms were further analyzed using the CIPN-20 symptom-specific scale.
Outcome measures
The primary outcome was the prevention or delay of CIPN onset in asymptomatic patients and the relief of CIPN symptoms in symptomatic patients. Secondary outcomes included improvements in QoL scores for all participants.
Ethical considerations
Informed consent was obtained from all participants prior to enrollment. The study adhered to the Declaration of Helsinki guidelines, ensuring the confidentiality and safety of participants.
Statistical analysis
Data were analyzed using SPSS software (IBM version 25). Descriptive statistics were presented as mean ± standard deviation for continuous variables and percentages for categorical variables. Comparisons between groups were conducted using the Kruskal–Wallis test for nonparametric data and paired t-tests for within-group analysis. Statistical significance was set at P < 0.05.
This comprehensive methodology ensured the reliability and validity of the study findings, providing a robust framework for evaluating the impact of Epsom salt foot baths on CIPN.
RESULT
Tables 1–13.
DISCUSSION
Chemotherapy-induced peripheral neuropathy (CIPN) is a prevalent and distressing complication among cancer patients undergoing neurotoxic chemotherapy. The findings of this study suggest that Epsom salt foot baths, a non-pharmacological intervention, are effective in both delaying the onset of CIPN in asymptomatic patients and alleviating symptoms in symptomatic cases. The intervention’s potential to improve quality-of-life outcomes further highlights its clinical utility in cancer care.
Effectiveness in preventing CIPN onset
In asymptomatic patients, the use of Epsom salt foot baths significantly delayed the onset of CIPN. This finding aligns with prior research indicating the neuroprotective role of magnesium sulfate, the primary component of Epsom salt. Magnesium has been shown to reduce oxidative stress and inflammation, both of which are implicated in CIPN pathogenesis.[9,10] The delayed onset observed in this study underscores the potential of Epsom salt to act as a preventative adjunct to standard chemotherapy protocols.
Symptom relief in symptomatic patients
For symptomatic patients, Epsom salt foot baths provided substantial relief from sensory and motor symptoms. The observed reduction in CIPN grades is consistent with findings from earlier studies on magnesium supplementation in neuropathy management.[11,12] This effect can be attributed to magnesium’s role in stabilizing neuronal excitability and mitigating nerve damage.[13]
Quality-of-life improvements
Quality-of-life scores were consistently better in experimental groups compared to controls. CIPN significantly diminishes patients’ functional capabilities and overall well-being, and addressing this aspect is critical for holistic cancer care. The transdermal absorption of magnesium through foot baths may offer an efficient and patient-friendly delivery method, bypassing the gastrointestinal side effects often associated with oral supplementation.[14,15]
Comparison with pharmacological interventions
While pharmacological agents, such as gabapentinoids and antidepressants, are commonly used for CIPN management, they often have limited efficacy and notable side effects.[16] Epsom salt foot baths, being noninvasive and cost-effective, offer a safer alternative. The lack of significant adverse effects in the experimental group further supports its potential for widespread adoption.
Study limitations and future directions
Although this study demonstrates promising results, certain limitations must be acknowledged. The single-center design may limit the generalizability of the findings. Additionally, the relatively short follow-up period precludes assessment of long-term outcomes. Future research should replicate these findings in larger, multi-center trials with extended follow-up durations. Investigating the biochemical mechanisms underlying magnesium absorption through the skin and its effects on nerve conduction could also provide valuable insights.
Clinical implications
The incorporation of Epsom salt foot baths into routine cancer care could represent a significant advancement in CIPN management. By reducing symptom severity and delaying onset, this intervention not only enhances patient comfort but also supports better adherence to chemotherapy regimens, ultimately improving treatment outcomes.[17,18]
Limitations
One limitation of this study is the relatively short duration of follow-up, which may not capture the long-term effects of Epsom salt foot baths on chemotherapy-induced peripheral neuropathy (CIPN). Additionally, the study was conducted in a single tertiary care center, which may limit the generalizability of the findings to other settings or populations. Future studies with larger sample sizes and extended follow-up periods are needed to validate these results and explore the sustained impact of this intervention.
CONCLUSION
This study demonstrates that Epsom salt foot baths are an effective and simple intervention for managing chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. The results showed significant benefits in both asymptomatic and symptomatic groups. In asymptomatic patients, the intervention successfully delayed the onset of CIPN, reducing deterioration rates significantly compared to the control group. In symptomatic patients, the foot baths provided substantial relief from sensory and motor symptoms, leading to improved functionality and quality of life. These findings underscore the potential of Epsom salt foot baths as an adjunctive therapy, offering a noninvasive, cost-effective approach to mitigate the neurological side effects of chemotherapy. Further research is encouraged to explore the long-term benefits and broader applicability of this intervention across diverse cancer populations.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
REFERENCES
1.Quasthoff S, Hartung HP. Chemotherapy-induced peripheral neuropathy. J Neurol 2002;249:9–17.
- Cited Here
2.Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, et al. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy:A systematic review and meta-analysis. Pain 2014;155:2461–70.
- Cited Here
3.Flatters SJL, Dougherty PM, Colvin LA. Clinical and preclinical perspectives on chemotherapy-induced peripheral neuropathy (CIPN):A narrative review. Br J Anaesth 2017;119:737–49.
- Cited Here
4.Loprinzi CL, Lacchetti C, Bleeker J, Cavaletti G, Chauhan C, Hertz DL, et al. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers:ASCO guideline update. J Clin Oncol 2020;38:3325–48.
- Cited Here
5.Gröber U, Schmidt J, Kisters K. Magnesium in prevention and therapy. Nutrients 2015;7:8199–226.
- Cited Here
6.Wolf FI, Trapani V. Cell (patho) physiology of magnesium. Clin Sci (Lond) 2008;114:27–35.
- Cited Here
7.Kaptanoglu E, Beskonakli E, Okutan O, Selcuk Surucu H, Taskin Y. Effect of magnesium sulphate in experimental spinal cord injury:Evaluation with ultrastructural findings and early clinical results. J Clin Neurosci 2003;10:329–34.
- Cited Here
8.Jensen TS, Madsen CS, Finnerup NB. Pharmacology and treatment of neuropathic pains. Curr Opin Neurol 2009;22:467–74.
- Cited Here
9.Lingam I, Robertson NJ. Magnesium as a neuroprotective agent:A review of its use in the fetus, term infant with neonatal encephalopathy, and the adult stroke patient. Dev Neurosci 2018;40:1–12 doi:10.1159/000484891
- Cited Here
10.Bao T, Basal C, Seluzicki C, Li SQ, Seidman AD, Mao JJ. Long-term chemotherapy-induced peripheral neuropathy among breast cancer survivors:Prevalence, risk factors, and fall risk. Breast Cancer Res Treat 2016;159:327–33.
- Cited Here
11.Loprinzi CL, Qin R, Dakhil SR, Fehrenbacher L, Flynn KA, Atherton P, et al. Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). J Clin Oncol 2013;32:997–1005.
- Cited Here
12.Zajączkowska R, Kocot-Kępska M, Leppert W, Wrzosek A, Mika J, Wordliczek J. Mechanisms of chemotherapy-induced peripheral neuropathy. Int J Mol Sci 2019;20:1451 doi:10.3390/ijms20061451
- Cited Here
13.Vink R, Nechifor M. Magnesium in the Central Nervous System Adelaide (AU) University of Adelaide Press 2011 Available from:http://www.ncbi.nlm.nih.g ov/books/NBK507264/ [Last accessed on 2024 Nov 19]
- Cited Here
14.Chandrasekaran NC, Sanchez WY, Mohammed YH, Grice JE, Roberts MS, Barnard RT. Permeation of topically applied Magnesium ions through human skin is facilitated by hair follicles. Magnes Res 2016;29:35–42.
- Cited Here
15.Gröber U, Werner T, Vormann J, Kisters K. Myth or reality-transdermal magnesium?. Nutrients 2017;9:813 doi:10.3390/nu9080813
- Cited Here
16.Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, et al. Pharmacotherapy for neuropathic pain in adults:A systematic review and meta-analysis. Lancet Neurol 2015;14:162–73.
- Cited Here
17.Zhang X, Wang A, Wang M, Li G, Wei Q. Non-pharmacological therapy for chemotherapy-induced peripheral neurotoxicity:A network meta-analysis of randomized controlled trials. BMC Neurol 2023;23:433
- Cited Here
18.Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, et al. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers:American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 2014;32:1941–67.
- Cited Here
Keywords:
Cancer; chemotherapy-induced peripheral neuropathy; Epsom salt foot bath; quality of life; randomized clinical trial