A randomized trial of adjunct testosterone for cancer-related muscle loss in men and women

Traver J. Wright, Edgar Dillon, William J. Durham, Albert Chamberlain, Kathleen M. Randolph, Christopher Danesi, Astrid M. Horstman, Charles R. Gilkison, Maurice Willis, Gwyn Richardson, Sandra Hatch, Daniel Jupiter, Susan Mccammon, Randall Urban, Melinda Sheffield-Moore

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background: Cancer cachexia negatively impacts cancer-related treatment options, quality of life, morbidity, and mortality, yet no established therapies exist. We investigated the anabolic properties of testosterone to limit the loss of body mass in late stage cancer patients undergoing standard of care cancer treatment. Methods: A randomized, double-blind, placebo-controlled phase II clinical trial was undertaken to assess the potential therapeutic role of adjunct testosterone to limit loss of body mass in patients with squamous cell carcinoma of the cervix or head and neck undergoing standard of care treatment including chemotherapy and chemoradiation. Patients were randomly assigned in blocks to receive weekly injections of either 100 mg testosterone enanthate or placebo for 7 weeks. The primary outcome was per cent change in lean body mass, and secondary outcomes included assessment of quality of life, tests of physical performance, muscle strength, daily activity levels, resting energy expenditure, nutritional intake, and overall survival. Results: A total of 28 patients were enrolled, 22 patients were studied to completion, and 21 patients were included in the final analysis (12 placebo, nine testosterone). Adjunct testosterone increased lean body mass by 3.2% (95% confidence interval [CI], 0-7%) whereas those receiving placebo lost 3.3% (95% CI, -7% to 1%, P = 0.015). Although testosterone patients maintained more favourable body condition, sustained daily activity levels, and showed meaningful improvements in quality of life and physical performance, overall survival was similar in both treatment groups. Conclusions: In patients with advanced cancer undergoing the early phase of standard of care therapy, adjunct testosterone improved lean body mass and was also associated with increased quality of life, and physical activity compared with placebo.

Original languageEnglish (US)
JournalJournal of Cachexia, Sarcopenia and Muscle
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Muscle Neoplasms
Testosterone
Placebos
Standard of Care
Quality of Life
Neoplasms
Therapeutics
Confidence Intervals
Phase II Clinical Trials
Cachexia
Survival
Second Primary Neoplasms
Controlled Clinical Trials
Muscle Strength
Cervix Uteri
Energy Metabolism
Squamous Cell Carcinoma
Neck
Head
Outcome Assessment (Health Care)

Keywords

  • Cachexia
  • Cancer
  • Female
  • Muscle
  • Quality of life
  • Testosterone

ASJC Scopus subject areas

  • Biophysics
  • Applied Microbiology and Biotechnology
  • Orthopedics and Sports Medicine
  • Physiology (medical)

Cite this

Wright, T. J., Dillon, E., Durham, W. J., Chamberlain, A., Randolph, K. M., Danesi, C., ... Sheffield-Moore, M. (Accepted/In press). A randomized trial of adjunct testosterone for cancer-related muscle loss in men and women. Journal of Cachexia, Sarcopenia and Muscle. https://doi.org/10.1002/jcsm.12295

A randomized trial of adjunct testosterone for cancer-related muscle loss in men and women. / Wright, Traver J.; Dillon, Edgar; Durham, William J.; Chamberlain, Albert; Randolph, Kathleen M.; Danesi, Christopher; Horstman, Astrid M.; Gilkison, Charles R.; Willis, Maurice; Richardson, Gwyn; Hatch, Sandra; Jupiter, Daniel; Mccammon, Susan; Urban, Randall; Sheffield-Moore, Melinda.

In: Journal of Cachexia, Sarcopenia and Muscle, 01.01.2018.

Research output: Contribution to journalArticle

Wright, Traver J. ; Dillon, Edgar ; Durham, William J. ; Chamberlain, Albert ; Randolph, Kathleen M. ; Danesi, Christopher ; Horstman, Astrid M. ; Gilkison, Charles R. ; Willis, Maurice ; Richardson, Gwyn ; Hatch, Sandra ; Jupiter, Daniel ; Mccammon, Susan ; Urban, Randall ; Sheffield-Moore, Melinda. / A randomized trial of adjunct testosterone for cancer-related muscle loss in men and women. In: Journal of Cachexia, Sarcopenia and Muscle. 2018.
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abstract = "Background: Cancer cachexia negatively impacts cancer-related treatment options, quality of life, morbidity, and mortality, yet no established therapies exist. We investigated the anabolic properties of testosterone to limit the loss of body mass in late stage cancer patients undergoing standard of care cancer treatment. Methods: A randomized, double-blind, placebo-controlled phase II clinical trial was undertaken to assess the potential therapeutic role of adjunct testosterone to limit loss of body mass in patients with squamous cell carcinoma of the cervix or head and neck undergoing standard of care treatment including chemotherapy and chemoradiation. Patients were randomly assigned in blocks to receive weekly injections of either 100 mg testosterone enanthate or placebo for 7 weeks. The primary outcome was per cent change in lean body mass, and secondary outcomes included assessment of quality of life, tests of physical performance, muscle strength, daily activity levels, resting energy expenditure, nutritional intake, and overall survival. Results: A total of 28 patients were enrolled, 22 patients were studied to completion, and 21 patients were included in the final analysis (12 placebo, nine testosterone). Adjunct testosterone increased lean body mass by 3.2{\%} (95{\%} confidence interval [CI], 0-7{\%}) whereas those receiving placebo lost 3.3{\%} (95{\%} CI, -7{\%} to 1{\%}, P = 0.015). Although testosterone patients maintained more favourable body condition, sustained daily activity levels, and showed meaningful improvements in quality of life and physical performance, overall survival was similar in both treatment groups. Conclusions: In patients with advanced cancer undergoing the early phase of standard of care therapy, adjunct testosterone improved lean body mass and was also associated with increased quality of life, and physical activity compared with placebo.",
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AU - Dillon, Edgar

AU - Durham, William J.

AU - Chamberlain, Albert

AU - Randolph, Kathleen M.

AU - Danesi, Christopher

AU - Horstman, Astrid M.

AU - Gilkison, Charles R.

AU - Willis, Maurice

AU - Richardson, Gwyn

AU - Hatch, Sandra

AU - Jupiter, Daniel

AU - Mccammon, Susan

AU - Urban, Randall

AU - Sheffield-Moore, Melinda

PY - 2018/1/1

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N2 - Background: Cancer cachexia negatively impacts cancer-related treatment options, quality of life, morbidity, and mortality, yet no established therapies exist. We investigated the anabolic properties of testosterone to limit the loss of body mass in late stage cancer patients undergoing standard of care cancer treatment. Methods: A randomized, double-blind, placebo-controlled phase II clinical trial was undertaken to assess the potential therapeutic role of adjunct testosterone to limit loss of body mass in patients with squamous cell carcinoma of the cervix or head and neck undergoing standard of care treatment including chemotherapy and chemoradiation. Patients were randomly assigned in blocks to receive weekly injections of either 100 mg testosterone enanthate or placebo for 7 weeks. The primary outcome was per cent change in lean body mass, and secondary outcomes included assessment of quality of life, tests of physical performance, muscle strength, daily activity levels, resting energy expenditure, nutritional intake, and overall survival. Results: A total of 28 patients were enrolled, 22 patients were studied to completion, and 21 patients were included in the final analysis (12 placebo, nine testosterone). Adjunct testosterone increased lean body mass by 3.2% (95% confidence interval [CI], 0-7%) whereas those receiving placebo lost 3.3% (95% CI, -7% to 1%, P = 0.015). Although testosterone patients maintained more favourable body condition, sustained daily activity levels, and showed meaningful improvements in quality of life and physical performance, overall survival was similar in both treatment groups. Conclusions: In patients with advanced cancer undergoing the early phase of standard of care therapy, adjunct testosterone improved lean body mass and was also associated with increased quality of life, and physical activity compared with placebo.

AB - Background: Cancer cachexia negatively impacts cancer-related treatment options, quality of life, morbidity, and mortality, yet no established therapies exist. We investigated the anabolic properties of testosterone to limit the loss of body mass in late stage cancer patients undergoing standard of care cancer treatment. Methods: A randomized, double-blind, placebo-controlled phase II clinical trial was undertaken to assess the potential therapeutic role of adjunct testosterone to limit loss of body mass in patients with squamous cell carcinoma of the cervix or head and neck undergoing standard of care treatment including chemotherapy and chemoradiation. Patients were randomly assigned in blocks to receive weekly injections of either 100 mg testosterone enanthate or placebo for 7 weeks. The primary outcome was per cent change in lean body mass, and secondary outcomes included assessment of quality of life, tests of physical performance, muscle strength, daily activity levels, resting energy expenditure, nutritional intake, and overall survival. Results: A total of 28 patients were enrolled, 22 patients were studied to completion, and 21 patients were included in the final analysis (12 placebo, nine testosterone). Adjunct testosterone increased lean body mass by 3.2% (95% confidence interval [CI], 0-7%) whereas those receiving placebo lost 3.3% (95% CI, -7% to 1%, P = 0.015). Although testosterone patients maintained more favourable body condition, sustained daily activity levels, and showed meaningful improvements in quality of life and physical performance, overall survival was similar in both treatment groups. Conclusions: In patients with advanced cancer undergoing the early phase of standard of care therapy, adjunct testosterone improved lean body mass and was also associated with increased quality of life, and physical activity compared with placebo.

KW - Cachexia

KW - Cancer

KW - Female

KW - Muscle

KW - Quality of life

KW - Testosterone

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