CTRI/2017/08/009574尚未招募2 期
A Multicentred, Randomized, Double-Blind, Placebo-Controlled, Parallel, Study Assessing CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) 1000 mg (3 times a day) in Improving Fatigue in Patients with Solid Stage I - IV Tumors.
atureceuticals Sdn Bhd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Males or females, >= age 18
- •2. Patients with solid tumors, Stage I-IV
- •3. Patients who received, receiving or plan to receive of chemotherapy and/or >= 1 week of radiotherapy.
- •4. ECOG 0-2
- •5. Life expectancy >= 6 months
- •6. Ability and willingness to provide written informed consent and comply
- •Inclusion criteria for randomization
- •1. At enrollment, subject will receive >= 2 cycles (21-day or 28 â??day cycle) of chemotherapy or >= 1 week of radiotherapy
- •2. Worsening of fatigue scoring as assessed by BFI questionnaire compared to previous scoring, defined as mild to moderate, moderate to severe, mild to severe, or newly developed fatigue
排除标准
- •1. Known allergy to CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) or any of the excipient used in the preparation of the investigational product
- •2. Any other known existing condition that contraindicate with the use of investigational product
- •3. Inability to take or consume the investigational product per protocol specified route of administration including peptic ulcer disease, chronic gastritis, hypotension and systolic blood pressure <90mmgHg.
- •4. Inability to understand local language (s) for which BFI, EORTC-QLQ-C30, FACIT-F, visual analogue scale for fatigue questionnaire
- •5. Any condition (e.g. Psychological, geographical etc.) that does not permit compliance with study or follow up procedures
- •6. Participation in any other clinical study using investigational medicinal product or device within 28 days prior baseline visit
- •7. Treatment with medications or supplements frequently associated with fatigue, such as interferon (within the last four months), beta-blockers, calcium channel blockers, benzodiazepines, sedating antihistamines, antidepressants, antipsychotics, or melatonin. In select instances, patients using these medications may be enrolled if, in the opinion of the investigators, their fatigue is clearly unrelated to the medication.
- •8. Untreated or uncontrolled comorbidities that influence fatigue, including thyroid disorders (TSH > 5 mcIU/mL), anemia (Hemoglobin < 9 g/dL), major depression, active substance abuse or other conditions as determined by the enrolling physician. Comorbidities that are adequately controlled will not exclude patients.
- •9. Chronic renal failure patients with raised serum potassium levels and abnormal renal function
- •10. Untreated sleep disorders such as obstructive sleep apnea or restless leg syndrome
- •11. Decompensated cirrhosis (encephalopathy, gastrointestinal bleeding, ascites, bilirubin > 2) within the last six months
- •12. Patients planning to travel outside the time zone during the study period
- •13. Known or suspected significant gastrointestinal motility disorder, obstruction, or structuring disease
- •14. Severe malnutrition according to WHO criteria.
- •15. Upon examination, patient may deemed to have any of the following conditions:
- •a. Bipedal oedema
- •b. Visible severe wasting
- •c. Weight for height more than 3 standard deviations below the median of international reference population
- •d. Fever related to systemic infection (especially Gram-negative coliforms such as Escherichia coli and Klebsiellapneumoniae), neutropenic sepsis
- •e. Respiratory distress
- •f. Heart failure
- •g. Electrolyte abnormalities (hypophosphataemia, hypokalaemia/ hyperkalaemia, hypoglycaemia etc.)
- •h. Marked anorexia
- •i. Profuse diarrhoea
- •16. The patient is female and :
- •a. is pregnant or fertile and is not practicing adequate methods of contraception,
- •b. is planning to become pregnant within 1 month of the study,
- •c. is breastfeeding.
研究者
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