NCT06151249尚未招募2 期
A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Safety and Ability of Meritup Oral Liquid to Reduce Fatigue in Patients With Metastatic Breast Cancer Receiving Chemotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Changes in fatigue scores
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of Meritup oral solution to decrease fatigue in metastatic breast cancer patients receiving chemotherapy.
详细描述
The study population designed to be enrolled is patients with histologically and/or cytologically confirmed breast cancer with clinical evidence of recurrent or progressive metastatic disease and at least completed 3 cycle chemotherapy regimen who have evidence of fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Chemotherapy+Meritup Chemotherapy+Placebo
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients over 20years old and under 80 years old.
- •Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor (HER2), These 3 indicators are all negative.
- •After at least 3 cycles of chemotherapy.
- •Sign the subject Informed Consent Form (ICF).
排除标准
- •Have received other clinical studies within 3 weeks
- •Any uncontrollable infection
- •History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma or multiple sclerosis
- •History of cancer cells that have metastasized to the brain
- •Currently receiving a mixture of three or more types of cytotoxic chemotherapy drugs
- •Currently using anti-fatigue treatments, including psychostimulants, acupuncture, etc. Note: Antidepressants are used for treatment to relieve fatigue (such as depression or hot flashes) is allowed,
- •Need to use long-acting sustained-release pain narcotic analgesics
- •Uncontrollable nausea, vomiting or other symptoms that will hinder the ability to speak about the test product
- •Any other serious illness/history that would limit the patient's ability to receive study treatment, as determined by the researcher evaluate
- •Lactation, pregnancy or planning pregnancy
- •People with cardiovascular disease or severe liver and kidney dysfunction should not drink it within one week after surgery.
结局指标
主要结局
Changes in fatigue scores
时间窗: one months
Changes in fatigue scores using the Functional Assessment of Chronic Illness Treatment (FACIT)-Fatigue subscale after 9 weeks of combined chemotherapy treatment
次要结局
- Blood test(one month)
研究者
相似试验
终止
2 期
Evaluate the Safety Profile and Ability of TW1025 Oral Solution to Decrease FatigueFatigueMetastatic Breast CancerNCT02645175Meriyana Bio Inc.3
已完成
3 期
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine in KoreanAcute MigraineNCT04218162IlDong Pharmaceutical Co Ltd294
已完成
2 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced ConstipationOpioid Induced ConstipationNCT01459926Glycyx Therapeutics217
终止
2 期
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT03517566Novartis Pharmaceuticals293
已完成
1 期
A Study of Aleglitazar in Combination With Aspirin in Healthy VolunteersHealthy VolunteerNCT01188304Hoffmann-La Roche44