NCT05241405招募中不适用
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer - Randomized, Placebo-controlled, Double-blind Study
Centre Francois Baclesse10 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2022年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 354
- 试验地点
- 10
- 主要终点
- Fatigue score change [min :5; max:20]
研究概览
简要总结
This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with localized breast or gynecological cancer treated as curative adjuvant and/or neoadjuvant chemotherapy and/or adjuvant radiotherapy. These treatments must have been completed within 6 months of inclusion.
- •Patient reporting a chronic, stable fatigue state at investigator assessment, defined as a fatigue score ≥ 4 on the visual analog scale rated up to 10, experienced for at least one month
- •Maintenance therapy with hormone therapy or other maintenance therapy (trastuzumab, bevacizumab…) is allowed before and/or during the study (except for pembrolizumab, abemaciclib and PARP inhibitors, which are not authorized)
- •Patient 18 years of age or older
- •Effective contraception in women of childbearing age
- •Patient affiliated to a social security plan
- •Signed informed consent
排除标准
- •Other identified causes of fatigue (anemia of grade > 2, underlying chronic disease known to be associated with fatigue)
- •Ongoing chemotherapy (patients scheduled for oral capecitabine or trastuzumab-emtasin in the adjuvant setting are not eligible)
- •Metastatic breast or gynecological cancer
- •Ongoing treatment with a tyrosine kinase inhibitor or other P-gp transported molecule or Pembrolizumab or PARP inhibitors
- •Patient requiring oral diabetes therapy
- •Regular intake of Vitamin C (in addition to what is provided by the diet)
- •Patients with chronic pain requiring daily treatment with analgesics, anti-inflammatory drugs or corticosteroids
- •Consumption of ginseng-based products in the month prior to inclusion
- •Hypersensitivity to any of the components of Qiseng or placebo
- •Pregnant or breastfeeding patient
- •Simultaneous participation in another therapeutic clinical trial (trial using an experimental product)
- •Patient deprived of liberty, under guardianship or curatorship
- •Patient unable to undergo the medical follow-up of the trial for geographical, social or psychopathological reasons
- •History of any other malignant disease during the last 3 years, except for skin cancer other than melanoma, carcinoma in situ of the uterus. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no signs of recurrence for at least 3 years
结局指标
主要结局
Fatigue score change [min :5; max:20]
时间窗: After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)
The difference between the initial (inclusion) score and the best score based on EORTC QLQ-FA12 questionnaire (physical fatigue dimension) between assessments at 1 week (S9) and 4 weeks (S12) after the end of treatment) will be calculated
次要结局
- Other dimensions of fatigue [min :12; max:48](after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment)
- The incidence of treatment-related adverse events(up to 8 weeks after the end of treatment)
- Quality of life level assessed by EORTC QLQ-C30 questionnaire(4 and 8 weeks of treatment and 4 weeks after the end of treatment)
- anxiety level(after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment)
- Cognitive function(after 4 and 8 weeks of treatment and 4 weeks after the end of treatment)
- Sleep quality(after 4 and 8 weeks of treatment and 4 weeks after the end of treatment)
- The level of acceptability of the treatment,(over a period of 8 weeks)
- Physical activity level(after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
American Ginseng in Treating Patients With Cancer-Related FatigueFatigueUnspecified Adult Solid Tumor, Protocol SpecificNCT00182780Alliance for Clinical Trials in Oncology290
已完成
不适用
Football Fitness After Breast CancerBreast Neoplasm FemaleNCT03284567University of Copenhagen69
已完成
3 期
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant TreatmentBreast CancerNCT01495650Institut du Cancer de Montpellier - Val d'Aurelle240
Unknown
不适用
American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer PatientsCancer Related FatigueBreast Cancer FemaleNCT03730298Network Italiano Cure di Supporto in Oncologia290
已完成
不适用
A randomized trial in cancer-related fatigue in palliatively treated patients: protocolized patient-tailored treatment of physical symptoms (PPT) vs care as usual (CAU).1. Advanced cancer<br />2. fatigue<br />3. cancer-related fatigue<br />4. CRF<br />5. palliative care.<br />(NLD: kanker, vermoeidheid, kankergerelateerde vermoeidheid, palliatieve zorg).NL-OMON23161Erasmus MC152