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Androgen replacement therapy for cancer-related symptoms in male advanced cancer patients: study protocol for a
Kouji Izumi1, Kazuyoshi Shigehara1, Takahiro Nohara1
1Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science.
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.
Insights
Androgen replacement therapy may improve quality of life in advanced cancer patients with hypogonadism. The ARTFORM trial investigated testosterone enanthate
Area of Science:
- Oncology
- Endocrinology
- Clinical Trials
Background:
- Hypogonadism (low serum androgen levels) is linked to advanced cancer and its symptoms.
- Testosterone deficiency is common in male cancer patients.
Purpose of the Study:
- To evaluate the efficacy of androgen replacement therapy (ART) in male advanced cancer patients.
- To assess the impact of testosterone enanthate on quality of life.
Main Methods:
- The ARTFORM study is a randomized controlled trial.
- Male patients with advanced cancer and low testosterone were randomized to receive intramuscular testosterone enanthate or no treatment.
- Health-related quality of life was measured using validated questionnaires at 12 weeks.
Main Results:
- The study compared quality of life scores between the treatment and control groups at week 12.
- Serum total and free testosterone levels were monitored.
Conclusions:
- The ARTFORM study provides data on the efficacy of androgen replacement therapy in advanced cancer.
- Results will inform treatment strategies for hypogonadal male cancer patients.
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