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Background <p>Acute pain syndrome (APS) is a common side effect of paclitaxel therapy. To date, there is no standard of care to prevent APS in patients receiving paclitaxel. Through this study, we aim to assess whether oral duloxetine reduces the incidence of paclitaxel-induced APS (P-APS) as compared to placebo.</p> Methods <p>This is a multi-centric, randomized (1:1), double-blind, placebo-controlled, parallel-group superiority trial. A total of 204 patients with breast cancer planned to receive paclitaxel will be randomly assigned to receive either oral duloxetine or a matched placebo for 7&#xa0;days after paclitaxel infusions for 4 cycles. The primary objective of the study is to compare the proportion of patients who develop P-APS in two groups. Key secondary objectives are to compare the quality of life (using the FACT-B scale), the incidence of peripheral neuropathy, the safety profile, and adherence with duloxetine. Patient-reported outcomes for P-APS and neuropathy will be assessed at the end of each cycle using BPI-SF and EORTC-CIPN20 questionnaires, respectively.</p> Discussion <p>The DOPA study is designed to evaluate whether oral duloxetine can reduce the occurrence of APS in patients receiving paclitaxel chemotherapy for breast cancer. Limited trials have assessed P-APS prevention using etoricoxib, dexamethasone, and pregabalin, but no pharmacological measure is effective. If the trial successfully meets its primary endpoint, oral duloxetine could become the new standard of care for preventing paclitaxel-induced APS.</p> Trial registration <p>Clinical Trials Registry of India – CTRI/2024/10/075636. Registered on 22 October 2024.</p>

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Randomized, double-blind, placebo-controlled study of oral duloxetine in prevention of acute pain syndrome in breast cancer patients receiving paclitaxel (DOPA study)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月18日

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  • Jahnavi Banotra,
  • Vrajesh Veenadhar Shetty,
  • Sameer Bakhshi,
  • Achal Kumar Srivastava,
  • Sudeep Gupta,
  • Akash Kumar,
  • Prabhat Bhargava,
  • Bharath Gangadhar,
  • Payal Vasudeva,
  • Kriti Pallavi,
  • Kamesh Bhati,
  • Shlok Singh,
  • Neha Verma,
  • Mohit Kumar Divakar,
  • Hemavathi Baskarane,
  • Atul Batra

摘要

Background

Acute pain syndrome (APS) is a common side effect of paclitaxel therapy. To date, there is no standard of care to prevent APS in patients receiving paclitaxel. Through this study, we aim to assess whether oral duloxetine reduces the incidence of paclitaxel-induced APS (P-APS) as compared to placebo.

Methods

This is a multi-centric, randomized (1:1), double-blind, placebo-controlled, parallel-group superiority trial. A total of 204 patients with breast cancer planned to receive paclitaxel will be randomly assigned to receive either oral duloxetine or a matched placebo for 7 days after paclitaxel infusions for 4 cycles. The primary objective of the study is to compare the proportion of patients who develop P-APS in two groups. Key secondary objectives are to compare the quality of life (using the FACT-B scale), the incidence of peripheral neuropathy, the safety profile, and adherence with duloxetine. Patient-reported outcomes for P-APS and neuropathy will be assessed at the end of each cycle using BPI-SF and EORTC-CIPN20 questionnaires, respectively.

Discussion

The DOPA study is designed to evaluate whether oral duloxetine can reduce the occurrence of APS in patients receiving paclitaxel chemotherapy for breast cancer. Limited trials have assessed P-APS prevention using etoricoxib, dexamethasone, and pregabalin, but no pharmacological measure is effective. If the trial successfully meets its primary endpoint, oral duloxetine could become the new standard of care for preventing paclitaxel-induced APS.

Trial registration

Clinical Trials Registry of India – CTRI/2024/10/075636. Registered on 22 October 2024.