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Subcutaneous octreotide therapy for malignant pleural effusion after pleurodesis with talc powder: a placebo-controlled, triple-blind, randomized trial

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Abstract

Purpose

In many cases, pleurodesis is the only treatment available for the treatment of malignant pleural effusion (MPE), and in the case of excessive daily pleural effusion, its therapeutic effect may be reduced. In this study, we intended to investigate the therapeutic effects and safety of octreotide in patients with MPE undergoing pleurodesis with talc powder.

Methods

This study was a single-center, placebo-controlled, and triple-blind, randomized trial designed to investigate the therapeutic effects and safety of octreotide in patients with MPE in Tehran, Iran, from March 2020 to March 2021. Patients with MPE were randomly divided into two parallel groups, one receiving subcutaneous octreotide (3 doses of 50 µg/day) and the other receiving placebo before and after pleurodesis with talc powder. The patients were followed up with a chest X-ray 1 week, 1 month, and 3 months later. The primary outcome measures of this study were the amount of discharge from the chest tube before and after pleurodesis and the length of hospital stay. Treatment failure, relapse, pleural effusion analysis, and side effects were considered the secondary outcome measures of the study.

Results

A total of 46 patients (23 in the octreotide group and 23 in the placebo group) with MPE was included in this study. Our findings demonstrated that adjunctive treatment with subcutaneous octreotide increases the efficacy of pleurodesis with talc powder. We showed that compared to the placebo group, patients in the octreotide group have significantly decreased production of pleural effusion both before (p = 0.009) and after (p = 0.002) pleurodesis. Octreotide treatment led to a decreased hospital stay (p = 0.004 before pleurodesis and p = 0.001 after pleurodesis) and reduced treatment failure (p = 0.022). However, octreotide did not decrease the relapse at 1-week, 1-month, and 3-month follow-ups. Moreover, octreotide did not affect pleural effusion parameters compared to placebo. Ultimately, our results also showed that treatment with octreotide was safe and did not have significant side effects.

Conclusion

Our findings demonstrated that adjunctive treatment with subcutaneous octreotide increases the efficacy of pleurodesis with talc powder without any significant side effects. Future studies with a larger sample size and longer follow-up time can confirm the results of this study and also determine the appropriate dose of octreotide for the treatment of MPE.

Trial registration

Iranian Registry of Clinical Trials, IRCT20210915052492N1. Registered 11 October 2021 – Retrospectively registered, https://www.irct.ir/trial/58776.

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Code availability

Not applicable.

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Author information

Author notes

  1. Reza Ershadi and Matin Vahedi have contributed equally work.

Authors and Affiliations

  1. Department of Thoracic Surgery, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran

    Reza Ershadi, Matin Vahedi, Javad Sarbaz Zadeh & Shahab Rafieian

  2. Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran

    Hossein Kazemi Zadeh

  3. Department of Surgery, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Farhad Fathi

  4. Department of Surgery, Birjand University of Medical Sciences, Birjand, Iran

    Hossein Ebrahimpour

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  1. Reza Ershadi
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Contributions

RE: conception and design of the study, drafting the article, and approval of the final version of manuscript; MV: acquisition of data, conception and design of the study, drafting the article, and approval of the final version of manuscript; HKZ: acquisition of data, critical revise, and approval of the final version of manuscript; FF: acquisition of data, critical revise, and approval of the final version of manuscript; HE: acquisition of data, critical revise, and approval of the final version of manuscript; JSZ: acquisition of data, critical revise, and approval of the final version of manuscript; SR: conception and design of the study, drafting the article, analysis and interpretation of data, and approval of the final version of manuscript.

Corresponding author

Correspondence to Shahab Rafieian.

Ethics declarations

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The ethics committee of Tehran University of Medical Sciences approved the study with the number IR.TUMS.IKCH.REC.1399.498.

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Informed consent was obtained from all individual participants included in the study.

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Informed consent was obtained from all individual participants included in the study.

Conflict of interests

The authors declare no competing interests.

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Ershadi, R., Vahedi, M., Zadeh, H.K. et al. Subcutaneous octreotide therapy for malignant pleural effusion after pleurodesis with talc powder: a placebo-controlled, triple-blind, randomized trial. Support Care Cancer 30, 9833–9840 (2022). https://doi.org/10.1007/s00520-022-07440-5

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