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Randomized double-blind clinical trial of combined treatment with megestrol acetate plus celecoxib versus megestrol acetate alone in cachexia-anorexia syndrome induced by GI cancers

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Abstract

Purpose

Previous studies reported promising efficacy for celecoxib in the treatment of cancer cachexia. We designed this study to test the hypothesis that combination therapy with megestrol acetate (MA) plus celecoxib is superior to MA alone.

Methods

Ninety eligible gastrointestinal cancer patients randomly received either MA 320 mg/day plus placebo (arm1) or MA 320 mg/day plus celecoxib 200 mg/day (arm2). Patients were evaluated at baseline, then 1 and 2 months after starting interventions. The primary outcome was body weight. Secondary outcomes were quality of life, grip strength, appetite score, performance status, plasma albumin, CRP, IL-6, and Glasgow Prognostic Score.

Results

Patients were comparable at baseline. Sixty patients were assessable for the first month and 33 patients for the second month. After 2 months, patients in arm1 (MA + placebo) and arm2 (MA + celecoxib) experienced 4.0 ± 3.4 and 2.2 ± 3.6Kg of weight gain respectively (P = 0.163). Changes relative to baseline were statistically significant in both arms of the study (P = 0.001). Regarding secondary outcomes, comparisons between groups did not show any statistically significant difference, but within-group changes were significant in both arms of the study.

Conclusion

Since both MA alone and MA plus celecoxib are associated with improvement of cachexia in GI cancer patients, this study failed to show that adding celecoxib (200 mg/day) to megestrol (320 mg/day) could enhance anti-cachexic effects of megestrol.

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Author information

Authors and Affiliations

  1. Student Research Committee, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran

    Bizhan Kouchaki

  2. Gastrointestinal Cancer Research Center, Mazandaran University of Medical Sciences, Sari, Iran

    Ghasem Janbabai, Samaneh Borhani & Ebrahim Salehifar

  3. Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran

    Abbas Alipour

  4. Pharmaceutical Research Center, Mazandaran University of Medical Sciences, Sari, Iran

    Shahram Ala

  5. Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Km 18 Khazarabad Road, Sari, Mazandaran, Iran

    Ebrahim Salehifar

Authors
  1. Bizhan Kouchaki
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  2. Ghasem Janbabai
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  3. Abbas Alipour
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  4. Shahram Ala
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Corresponding author

Correspondence to Ebrahim Salehifar.

Ethics declarations

The protocol was approved by Mazandaran University of Medical Sciences Ethical Committee (IR.MAZUMS.REC.94-1087) and registered in Iranian Registry of Clinical Trials (IRCT201407222027N4). All patients gave written informed consent before inclusion into the study.

Conflict of interest

The authors declare that they have no competing interests.

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Kouchaki, B., Janbabai, G., Alipour, A. et al. Randomized double-blind clinical trial of combined treatment with megestrol acetate plus celecoxib versus megestrol acetate alone in cachexia-anorexia syndrome induced by GI cancers. Support Care Cancer 26, 2479–2489 (2018). https://doi.org/10.1007/s00520-018-4047-y

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