Effects of Anamorelin on Cancer-Related-Fatigue in Patients With Advanced Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
研究概览
简要总结
This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate changes in the Functional Assessment of Cancer Illness Therapy-Fatigue (FACIT-F) subscale score at day 43 +/- 3 days compared to baseline in patients with advanced cancer receiving oral anamorelin hydrochloride (anamorelin) 100 mg daily and standardized physical activity and nutritional counseling.
SECONDARY OBJECTIVES:
I. To examine the effects of anamorelin and standardized physical activity and nutritional counseling on health-related quality of life and patient reported outcomes as measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Patient Reported Outcomes Measurement Information System (PROMIS) - Fatigue, Hospital Anxiety Depression Scale (HADS), Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Cancer Therapy (FACT-G) and its Functional Assessment of Anorexia/Cachexia Treatment (FAACT) subscale in these patients.
II. To examine the side effects and tolerability of anamorelin in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
- •Presence of fatigue on FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
- •Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
- •CRP must be >= 3 mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
- •No evidence of moderate to severe depression as determined by a HADS depression score of =< 13
- •Presence of unintentional weight loss ranging from >= 2 - =< 15% in last 12 months
- •Uncontrolled pain; if patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (> 25%) for at least 48 hours prior to study entry; the dose of morphine equivalent daily should not exceed 120 mg/day unless approved by the principal investigator (PI); change in opioid dose after study entry is allowed
- •Patient must be willing to engage in telephone follow up with research staff
- •Patient must have telephone access to be contacted by the research staff
- •Hemoglobin level of >= 9 g/dL
- •Estimated life expectancy of > 4 months at the time of screening
- •Aspartate transaminase (AST) and alanine transaminase (ALT) levels =< 5 x upper limit of normal (ULN)
排除标准
- •Major contraindications to anamorelin e.g. hypersensitivity
- •Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a week
- •Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
- •Pregnant or lactating women, childbearing age women who are not on birth control; negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications: women who are able to become pregnant must use birth control during the study and for 30 days after the last anamorelin dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
- •Uncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screening
- •Male patients with a history of untreated hypogonadism
- •Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks (ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin)
- •Patients on drugs that may prolong the PR or QRS interval durations, such as any of the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided (e.g. flecainide, procainamide, propafenone, quinidine)
- •Patients with untreated clinically relevant hypothyroidism
- •Patients currently on investigational therapies will be evaluated by the PI on a case by case basis and study participation approval will be obtained from the treating oncologist
- •Patients with prostate cancer
研究组 & 干预措施
Supportive Care (anamorelin, physical activity, counseling)
Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
干预措施: Laboratory Biomarker Analysis (Other)
Supportive Care (anamorelin, physical activity, counseling)
Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
干预措施: Anamorelin Hydrochloride (Drug)
Supportive Care (anamorelin, physical activity, counseling)
Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
干预措施: Exercise Intervention (Behavioral)
Supportive Care (anamorelin, physical activity, counseling)
Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
干预措施: Nutritional Assessment (Other)
Supportive Care (anamorelin, physical activity, counseling)
Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
干预措施: Quality-of-Life Assessment (Other)
Supportive Care (anamorelin, physical activity, counseling)
Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
时间窗: Baseline up to day 43
FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. We calculated the mean change in FACIT-F fatigue subscale from baseline to Day 43.
次要结局
- Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue(Baseline up to day 43)
- The Edmonton Symptom Assessment Scale (ESAS)-Fatigue(Baseline up to day 43)
- Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue(Baseline up to day 43)