Testosterone replacement for fatigue in hypogonadal ambulatory males with advanced cancer: A preliminary double-blind placebo-controlled trial

Supportive Care in Cancer

Volumn 21, Issue 9, 2013, Pages 2599-2607

  Del Fabbro, E ^a,c   Garcia, J M ^b   Dev, R ^a   Hui, D ^a   Williams, J ^a   Engineer, D ^b   Palmer, J L ^a   Schover, L ^a   Bruera, E ^a  

^a UNIVERSITY OF TEXAS   (United States)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

Author keywords

Cancer; Fatigue; Hypogonadal; Males; Replacement; Testosterone

Indexed keywords

ANTINEOPLASTIC AGENT; PLACEBO; SESAME SEED OIL; TESTOSTERONE ENANTATE;

ADULT; ADVANCED CANCER; ANDROGEN THERAPY; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BIOAVAILABILITY; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFECT; EDMONTON SYMPTOM ASSESSMENT SCALE; FATIGUE; FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY FATIGUE SUBSCALE; FUNCTIONAL STATUS; HUMAN; HYPOGONADISM; MALE; OUTPATIENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SCORING SYSTEM; SEXUAL DESIRE INVENTORY SCORE; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

AGED; ANDROGENS; CACHEXIA; DEPRESSION; DEPRESSIVE DISORDER; DOUBLE-BLIND METHOD; FATIGUE; HAND STRENGTH; HUMANS; HYPOGONADISM; MALE; MIDDLE AGED; MUSCLE STRENGTH DYNAMOMETER; NEOPLASMS; TESTOSTERONE; TREATMENT OUTCOME;

EID: 84881224912     PISSN: 09414355     EISSN: 14337339     Source Type: Journal    
DOI: 10.1007/s00520-013-1832-5     Document Type: Article

References (43)

1. Strasser F, Palmer JL, Schover LR et al (2006) The impact of hypogonadism and autonomic dysfunction on fatigue, emotional function, and sexual desire in male patients with advanced cancer: a pilot study. Cancer 107:2949-2957 (Pubitemid 44937051)
2. Burney BO, Hayes TG, Smiechowska J et al (2012) Low testosterone levels and increased inflammatory markers in patients with cancer and relationship with cachexia. J Clin Endocrinol Metab 97:700-709
3. Chlebowski RT, Heber D (1982) Hypogonadism in male patients with metastatic cancer prior to chemotherapy. Cancer Res 42:2495-2498 (Pubitemid 12121481)
4. Del Fabbro E, Hui D, Nooruddin ZI et al (2010) Associations among hypogonadism, C-reactive protein, symptom burden, and survival in male cancer patients with cachexia: a preliminary report. J Pain Symptom Manag 39:1016-1024
5. Rabkin JG, Wagner GJ, Rabkin R (2000) A double-blind, placebo-controlled trial of testosterone therapy for HIV-positive men with hypogonadal symptoms. Arch Gen Psychiatry 57:141-147 (Pubitemid 30075264)
6. Patrick DL, Ferketich SL, Frame PS et al (2004) National Institutes of Health State-of-the-Science Conference Statement: Symptom management in cancer: pain, depression, and fatigue, July 15-17, 2002. National Institutes of Health State-of-the-Science Panel. J Natl Cancer Inst Monogr 32:9-16
7. Bhasin S, Cunningham GR, Hayes FJ et al (2006) Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 91:1995-2010 (Pubitemid 43854972)
8. Garcia JM, Li H, Mann D, Epner D et al (2006) Hypogonadism in male patients with cancer. Cancer 106:2583-2591
9. Rajagopal A, Vassilopoulou-Sellin R, Palmer JL, Kaur G, Bruera E (2004) Symptomatic hypogonadism in male survivors of cancer with chronic exposure to opioids. Cancer 100:851-858 (Pubitemid 38176866)
10. Gerl A, Muhlbayer D, Hansmann G, Mraz W, Hiddemann W (2001) The impact of chemotherapy on Leydig cell function in long term survivors of germ cell tumors. Cancer 91:1297-1303 (Pubitemid 32267041)
11. Dev R, Del Fabbro E, Bruera E (2007) Association between megestrol acetate treatment and symptomatic adrenal insufficiency with hypogonadism in male patients with cancer. Cancer 110:1173-1177 (Pubitemid 47435585)
12. Malkin CJ, Pugh PJ, Morris PD, Kerry KE, Jones RD, Jones TH, Channer KS (2004) Testosterone replacement in hypogonadal men with angina improves ischaemic threshold and quality of life. Heart 90:871-878 (Pubitemid 39005930)
13. Chiang HS, Cho SL, Lin YC, Hwang TI (2009) Testosterone gel monotherapy improves sexual function of hypogonadal men mainly through restoring erection: evaluation by IIEF score. Urology 73:762-766
14. Cherrier MM, Asthana S, Plymate S, Baker L, Matsumoto AM, Peskind E, Raskind MA, Brodkin K, Bremner W, Petrova A, LaTendresse S, Craft S (2001) Testosterone supplementation improves spatial and verbal memory in healthy older men. Neurology 57:80-88 (Pubitemid 32634854)
15. Bhasin S, Storer TW, Javanbakht M, Berman N, Yarasheski KE, Phillips J, Dike M, Sinha-Hikim I, Shen R, Hays RD, Beall G (2000) Testosterone replacement and resistance exercise in HIV-infected men with weight loss and low testosterone levels. JAMA 283:763-770 (Pubitemid 30084616)
16. Morley JE, Charlton E, Patrick P, Kaiser FE, Cadeau P, McCready D, Perry HM (2000) Validation of a screening questionnaire for androgen deficiency in aging males. Metabolism 49:1239-1242
17. Bruera E, Kuehn N, Miller MJ et al (1991) The Edmonton Symptom Assessment System (ESAS). J Palliat Care 7:6-9
18. Chang VT, Hwang SS, Feuerman M (2000) Validation of the Edmonton Symptom Assessment Scale. Cancer 88:2164-2171 (Pubitemid 30233220)
19. Cella D, Tulsky DS, Gray G et al (1993) The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 11:570-579 (Pubitemid 23071057)
20. Ribaudo JM, Cella D, Hahn EA, Lloyd SR, Tchekmedyian NS et al (2000) Re-validation and shortening of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Qual Life Res 9:1137-1146 (Pubitemid 32452957)
21. Johnston M, Pollard B, Hennessey P (2000) Construct validation of the hospital anxiety and depression scale with clinical populations. J Psychosomatic Res 48:579-584
22. Spector IP, Carey MP, Steinberg L (1996) The Sexual Desire Inventory: development, factor structure, and evidence of reliability. J Sex Marital Ther 22:175-190 (Pubitemid 26314103)
23. Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC et al (1992) for The Measurement Committee of the American Urological Association, The American Urological Association symptom index for benign prostatic hyperplasia. J Urol 148:1549-1557
24. American Thoracic Society (2002) ATS Statement: Guidelines for the Six-Minute Walk Test. Am J Respir Crit Care Med 166:111-117
25. Sousa N, Sampaio J (2005) Effects of progressive strength training on the performance of the Functional Reach Test and the Timed Get-Up-and-Go Test. Am J Hum Biol 17:746-751 (Pubitemid 43082487)
26. Wheeler MJ (1995) The determination of bioavailable testosterone. Ann Clin Biochem 32:345-357
27. Oken MM, Creech RH, Tormey DC et al (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J ClinOncol 5:649-655 (Pubitemid 13149996)
28. Lai JS, Beaumont JL, Ogale S, Brunetta P, Cella D (2011) Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial. J Rheumatol 38:672-679
29. Cella D, Hahn EA, Dineen K (2002) Meaningful change in cancerspecific quality of life scores: differences between improvement and worsening. Qual Life Res 11:207-221 (Pubitemid 34553502)
30. Yost KJ, Sorensen MV, Hahn EA, Glendenning GA, Gnanasakthy A, Cella D (2005) Using multiple anchor- and distribution-based estimates to evaluate clinically meaningful change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) instrument. Value Health 8:117-127 (Pubitemid 40525373)
31. Cella D, Eton DT, Lai JS et al (2002) Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment ofCancer Therapy (FACT) Anemia and Fatigue scales. J PainSymptom Manage 24:547-561 (Pubitemid 36120443)
32. Lindau ST, Gavrilova N (2010) Sex, health, and years of sexually active life gained due to good health: evidence from two US population based cross sectional surveys of ageing. BMJ 9:340-c810
33. Garcia JM, Li H, Mann D, Epner D, Hayes TG, Marcelli M, Cunningham GR (2006) Hypogonadism in male patients with cancer. Cancer 106:2583-2591
34. Shafqat A, Einhorn LH, Hanna N, Sledge GW, Hanna A, Juliar BE, Monahan P, Bhatia S (2005) Screening studies for fatigue and laboratory correlates in cancer patients undergoing treatment. Ann Oncol 16:1545-1550 (Pubitemid 41222429)
35. Coviello AD, Kaplan B, Lakshman KM, Chen T, Singh AB, Bhasin S (2008) Effects of graded doses of testosterone on erythropoiesis in healthy young and older men. J Clin Endocrinol Metab 93:914-919 (Pubitemid 351398573)
36. Munch TN, Zhang T, Willey J, Palmer JL, Bruera E (2005) The association between anemia and fatigue in patients with advanced cancer receiving palliative care. J Palliat Med 8:1144-1149 (Pubitemid 43010546)
37. Minton O, Strasser F, Radbruch L, Stone P (2012) Identification of factors associated with fatigue in advanced cancer: a subset analysis of the European palliative care research collaborative computerized symptom assessment data set. J Pain Symptom Manage 43(2):226-235
38. Mercadante S, Ferrera P, Villari P, David F, Giarratano A, Riina S (2009) Effects of red blood cell transfusion on anemia-related symptoms in patients with cancer. J Palliat Med 12:60-63
39. Trutschnigg B, Kilgour RD, Reinglas J, Rosenthall L, Hornby L, Morais JA, Vigano A (2008) Precision and reliability of strength (Jamar vs. Biodex handgrip) and body composition (dual-energy X-ray absorptiometry vs. bioimpedance analysis) measurements in advanced cancer patients. Appl Physiol Nutr Metab 33:1232-1239
40. MacDonald AJ, Greig CA, Baracos V (2011) The advantages and limitations of cross-sectional body composition analysis. Curr Opin Support Palliat Care 5:342-349
41. Eggertson L (2011) Brouhaha erupts over testosterone-testing advertising campaign. CMAJ 183:1161-1162
42. Marks LS, Mazer NA, Mostaghel E et al (2006) Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. JAMA 296:2351-2361 (Pubitemid 44749363)
43. Rhoden EL, Morgentaler A (2003) Testosterone replacement therapy in hypogonadal men at high risk for prostate cancer: results of 1 year of treatment in men with prostatic intraepithelial neoplasia. J Urol 170:2348-2351 (Pubitemid 37413994)