This preprint is under consideration at Journal of Gastrointestinal Cancer. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Nima Mousavi Darzikolaee
Tehran University of Medical Sciences
Corresponding Author
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Introduction
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 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 arm. We compared the two arms based on the incidence of neuropathy and the results of the nerve conduction study.
Results
Thirty two patients were randomized to duloxetine and placebo arms. Most of the patients had rectal cancer (90.6%). Compared with the placebo arm, patients in the duloxetine arm had a lower percentage of chemotherapy cycles (mean) in which they reported distal paresthesia (84% vs. 51%, P = 0.01) and throat discomfort (69% vs. 37%, P = 0.01). There was no difference in the percentage of cycles in which patients reported cold-induced dysesthesia. Highest grade of neuropathy in each cycle was not significantly different between the two arms. Six weeks after the last cycle of chemotherapy, nerve conduction velocity was significantly higher in duloxetine arm compared to the placebo arm in the deep peroneal nerve and tibial nerve. Duloxetine was safe and well-tolerated.
Conclusion
In spite of small sample size, results of this study suggests potential efficacy of duloxetine in the prevention of OIPN, as indicated by objective measures of neurotoxicity and some patient-reported symptoms.
Keywords
Oxaliplatin, Peripheral Neuropathy, Duloxetine, Prevention
Figure 1
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- SupplementalTable.docx
Table 8 (supplementary Information) Nerve conduction velocity and Amplitude 6 weeks after last Cycle of Chemotherapy
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This preprint is under consideration at Journal of Gastrointestinal Cancer. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Nima Mousavi Darzikolaee
Tehran University of Medical Sciences
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 24 Mar, 2021
No community comments so far
Reviewers invited
Invitations sent on 21 Mar, 2021
First submitted
On 21 Mar, 2021
Editor assigned
On 20 Mar, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Introduction
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 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 arm. We compared the two arms based on the incidence of neuropathy and the results of the nerve conduction study.
Results
Thirty two patients were randomized to duloxetine and placebo arms. Most of the patients had rectal cancer (90.6%). Compared with the placebo arm, patients in the duloxetine arm had a lower percentage of chemotherapy cycles (mean) in which they reported distal paresthesia (84% vs. 51%, P = 0.01) and throat discomfort (69% vs. 37%, P = 0.01). There was no difference in the percentage of cycles in which patients reported cold-induced dysesthesia. Highest grade of neuropathy in each cycle was not significantly different between the two arms. Six weeks after the last cycle of chemotherapy, nerve conduction velocity was significantly higher in duloxetine arm compared to the placebo arm in the deep peroneal nerve and tibial nerve. Duloxetine was safe and well-tolerated.
Conclusion
In spite of small sample size, results of this study suggests potential efficacy of duloxetine in the prevention of OIPN, as indicated by objective measures of neurotoxicity and some patient-reported symptoms.
Figure 1
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