Androgen replacement therapy for cancer-related symptoms in male advanced cancer patients: study protocol for a randomised prospective trial (ARTFORM study)

Kouji Izumi; Kazuyoshi Shigehara; Takahiro Nohara; Kazutaka Narimoto; Yoshifumi Kadono; Shigeki Nanjo; Tadaaki Yamada; Koushiro Ohtsubo; Seiji Yano; Atsushi Mizokami

doi:10.2152/jmi.64.202

Originals

Androgen replacement therapy for cancer-related symptoms in male advanced cancer patients: study protocol for a randomised prospective trial (ARTFORM study)

Kouji Izumi, Kazuyoshi Shigehara, Takahiro Nohara, Kazutaka Narimoto, Yoshifumi Kadono, Shigeki Nanjo, Tadaaki Yamada, Koushiro Ohtsubo, Seiji Yano, Atsushi Mizokami

Author information

Kouji Izumi
Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Kazuyoshi Shigehara
Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Takahiro Nohara
Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Kazutaka Narimoto
Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Yoshifumi Kadono
Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Shigeki Nanjo
Division of Medical Oncology Cancer Research Institute, Kanazawa University
Tadaaki Yamada
Division of Medical Oncology Cancer Research Institute, Kanazawa University
Koushiro Ohtsubo
Division of Medical Oncology Cancer Research Institute, Kanazawa University
Seiji Yano
Division of Medical Oncology Cancer Research Institute, Kanazawa University
Atsushi Mizokami
Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science

Keywords: advanced cancer, androgen replacement therapy, health-related quality of life, randomised controlled trial, testosterone

JOURNAL FREE ACCESS

2017 Volume 64 Issue 3.4 Pages 202-204

DOI https://doi.org/10.2152/jmi.64.202

Details

Abstract

Recent studies reveal that hypogonadism with low serum androgen levels is associated with advanced cancer and induction of most cancer-related symptoms. We designed an ARTFORM study to evaluate the efficacy of androgen replacement therapy in male advanced cancer patients. The ARTFORM study is an investigator-initiated, randomised controlled trial comparing intramuscle injection of testosterone enanthate with non-administration in male advanced cancer patients with non-curative locally advanced or metastatic lesions. Serum total and free testosterone levels are measured and patients with low testosterone level are randomised. The primary endpoint is the difference in validated health-related quality of life questionnaires at week 12. Trial registration of the ARTFORM study is assigned to University hospital Medical Information Network, Center identifier UMIN 000010939. J. Med. Invest. 64: 202-204, August, 2017

Corresponding author

Register with J-STAGE for free!