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Duloxetine for the Prevention of Oxaliplatin Induced Peripheral Neuropathy: A Randomized, Placebo-Controlled, Double-blind Clinical Trial

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Abstract

Purpose

Peripheral neuropathy is a dose-limiting adverse effect of oxaliplatin. The aim of this study was to evaluate the efficacy and safety of duloxetine in the prevention of oxaliplatin-induced peripheral neuropathy (OIPN).

Method

Cancer patients receiving oxaliplatin based chemotherapy were randomized into two arms. Duloxetine 60 mg capsule was given in the first 14 days of each chemotherapy cycle to one arm and placebo was similarly given to another. We compared the two arms based on the incidence of neuropathy and the results of the nerve conduction study (NCS). Grade of complained neuropathy was recorded according to Common Terminology Criteria for Adverse Events (CTCAE).

Results

Thirty-two patients mostly rectal cancer (90.6%) were randomized to duloxetine and placebo arms. Highest grade of neuropathy in each cycle was not significantly different between the two groups. Six weeks after treatment incidence of neuropathy of any grade was 52.9 in duloxetine arm compared to 76.9% in placebo arm (P: 0.26). Patients in the duloxetine arm had a lower percentage of chemotherapy cycles (mean) in which they reported distal paresthesia (51% vs. 84%, P = 0.01) and throat discomfort (37% vs. 69%, P = 0.01). Results of NCS were mostly comparable between the two arms except for the velocity in two of the examined nerve which was significantly higher in duloxetine group. Duloxetine was safe and well-tolerated.

Conclusion

Although a definite conclusion might be difficult to draw but administering duloxetine for 14 days in each chemotherapy cycle could not decrease the incidence of acute OIPN based on CTCAE grading system.

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Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Acknowledgements

This study was a part of post graduate thesis supported by Tehran university of medical sciences (grant number: 9311282025).

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Authors and Affiliations

  1. Radiation Oncology Research Center (RORC), Cancer Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Keshavarz Blvd, Tehran, Iran

    Mahdi Aghili, Nima Mousavi Darzikolaee, Mohammad Babaei, Reza Ghalehtaki, Farshid Farhan, Saeed Rezaei, Ebrahim Esmati, Farhad samiei, Borna Farazmand & Ardavan Amiri

  2. Department of Physical Medicine and Rehabilitation, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran

    Seyede Zahra Emami Razavi & Mohaddeseh Azadvari

  3. Department of Radiation Oncology, Hamadan University of Medical Sciences, Hamadan, Iran

    Reyhaneh Bayani

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  1. Mahdi Aghili
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Corresponding author

Correspondence to Nima Mousavi Darzikolaee.

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This study was performed in line with the principles of the Declaration of Helsinki and approved by institutional review board and ethical committee.

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Aghili, M., Darzikolaee, N.M., Babaei, M. et al. Duloxetine for the Prevention of Oxaliplatin Induced Peripheral Neuropathy: A Randomized, Placebo-Controlled, Double-blind Clinical Trial. J Gastrointest Canc 54, 467–474 (2023). https://doi.org/10.1007/s12029-022-00824-0

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  • DOI: https://doi.org/10.1007/s12029-022-00824-0

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