A Preliminary Trial of Testosterone Replacement for Fatigue in Male Hypogonadic Patients With Advanced Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days)
研究概览
简要总结
The goal of this clinical research study is to learn if and how testosterone replacement therapy may affect fatigue in males with advanced cancer and low testosterone levels.
详细描述
Background for Study:
Testosterone is the main sex hormone for males. Cancer, cancer treatments and cancer symptoms can cause its levels in the body to drop below normal. When testosterone is taken as a drug (called "testosterone replacement therapy"), this therapy is designed to return the testosterone levels to normal. This may help to control symptoms of low testosterone levels, which may include fatigue.
In addition to fatigue, low testosterone levels may also cause depression, loss of sexual desire, loss of appetite, and/or physical changes such as effects on strength, stamina (long-lasting strength and energy), energy level, and body composition. In this study, researchers also want to learn how testosterone therapy may affect these other symptoms that may occur. To measure these effects, questionnaires and other tests will be used.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. One group will receive testosterone, and the other group will receive a placebo. A placebo is a substance that looks like the study drug but has no active ingredients. There is an equal chance that you will be assigned to either group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with any advanced cancer (metastatic or locally recurrent) who have a bioavailable testosterone (BT) of < 70 ng/dL.
- •Male patients who have fatigue present every day for the last two weeks and have an Edmonton Symptom Assessment System (ESAS) fatigue score during the last 24 hours of >/= to 4 on a 0 to 10 scale (in which 0 = no fatigue and 10 = worst possible fatigue).
- •Male patients who are willing to receive intramuscular injections every 2 weeks and are 18 years of age or older are eligible for this study.
- •Participants must be willing to have blood samples drawn at screening and/or baseline and every two weeks until the end of treatment.
- •Prostatic Specific Antigen (PSA) level must be lower than 4.0 ng/mL to be eligible for this study and Digital Rectal Exam (DRE) must be normal.
- •Eastern Cooperative Oncology Group (ECOG) PS </= 3 and participants must be able to stand up with or without assistance and to ambulate.
- •Hemoglobin (Hgb) >/= 9 g/dL. If the patient has not had blood drawn for a hemoglobin level in the past 28 days, one will be done to determine eligibility. Patients with a hemoglobin < 9 g/dL will be referred for treatment of their anemia.
排除标准
- •Patients who are determined incapable of completing questionnaires due to cognitive or physical deficits are ineligible for this study
- •Abnormal Digital Rectal Exam (DRE) at baseline or history of severe untreated benign prostatic hypertrophy (BPH) with International Prostatic Symptom Score (IPSS) >
- •Patients with a history of prostate cancer, a history of breast cancer or adenocarcinoma of unknown origin.
- •A history of untreated obstructive sleep apnea.
- •Uncontrolled severe heart failure (NYHA Class III or IV), uncontrolled cardiac arrhythmia or severe chronic obstructive pulmonary disease (COPD) requiring home oxygen.
- •Patients who have evidence of pre-existing hypopituitarism/hypogonadism including status post bilateral orchiectomy, for which replacement therapy is mandated, are ineligible for this study.
- •Patients exhibiting clinically diagnosed severe dehydration are ineligible.
- •Patients with a history of uncontrolled arrhythmia.
- •Patients who are currently receiving androgen therapy or dehydroepiandrosterone (DHEA)
- •Diabetics with a history of frequent episodes of hypoglycemia or uncontrolled diabetes mellitus (DM) defined as a fasting glucose over 200 mg/dL or HbA1c above 8%.
- •Uncontrolled thyroid disease
- •Hypercalcemia (corrected calcium > 10.5 g/dL); estimated glomerular filtration rate < 60 mg/min using the Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR); ALT > 3x the upper limit of normal (UNL)
- •Patients on warfarin, cyclosporine, dong quai, eucalyptus, dicumarol, germander, Jin bu huan, kava, pennyroyal, chaparral, comfrey, phenprocoumon are ineligible for this study.
- •Unstable symptoms could contribute to fatigue such as severe pain (score> 6 on ESAS) or severe depression (defined as a score of 15 or greater on the Depression Subscale of the Hospital Anxiety Depression Scale [HADS]). These symptoms should be resolved or stable for >/= 2 weeks at baseline for inclusion into study.
- •Patients with hematocrit (Hct) > upper normal limits (UNL) will be excluded due to possible polycythemia. If the patient has not had blood drawn for a hematocrit level in the past 28 days, one will be performed at baseline to determine eligibility.
- •Patients who have a known sensitivity to sesame seed products.
研究组 & 干预措施
Testosterone
Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
干预措施: Testosterone (Drug)
Placebo
Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
干预措施: Placebo (Drug)
结局指标
主要结局
Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days)
时间窗: Day 29 (+/- 3 days)
The primary endpoint was to evaluate the effect of testosterone replacement therapy on fatigue in hypogonadic male patients with advanced cancer, measured by the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days). FACIT-F consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4. The FACIT-F total score ranged between 0 and 108, with higher scores denoting improved function. The FACIT-F Fatigue Subscale ranges from 0 to 52, with higher scores represent better (less) fatigue than a lower score. A positive difference score (29 days minus baseline) represents improvement. A greater positive difference score represents greater improvement.
次要结局
- The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS).(Day 29 (+/- 3 days))