ChiCTR2500112638尚未招募Unknown
A pilot, open-label case series on the efficacy and safety of a synbiotic formula (HQP08) in preventing and managing chemotherapy-induced alopecia in cancer patients
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 试验地点
- 1
- 主要终点
- Prevention of Significant Hair Loss
研究概览
简要总结
- To explore the efficacy and safety of a synbiotic formula (HQP08) in preventing and managing chemotherapy-induced alopecia in cancer patients
- To study the compositional and functional changes in gut microbiome
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 60（—）
- 性别
- All
入选标准
- •Individuals aged 18 - 60 who is newly diagnosed with stage I, II or III cancer
- •Planned chemotherapy to be completed within 6 months
- •Literate and can complete the self-report questionnaires
- •Able to understand the consent and sign the informed consent form
排除标准
- •Metastatic cancers with life expectancy <6 months
- •Pre-existing female-pattern or male-pattern baldness
- •History of hair transplantation, psoriasis or severe scalp infection
- •Undergoing or plan to receive scalp cooling
- •Plan for immunotherapy
- •Severe cardiac, hepatic, renal, pulmonary and haematic lesions or other life-threatening conditions
- •Known pregnancy or lactating
- •Use of antibiotics, probiotics or prebiotics in the last 4 weeks
- •History of allergy to probiotics or lactose
- •History of chemotherapy for other conditions
研究组 & 干预措施
病例组
对照组
结局指标
主要结局
Prevention of Significant Hair Loss
次要结局
- Changes in self-reported hair loss severity
- Changes in self-reported hair loss
- Changes in hair loss severity
- Changes in depression level
- Changes in anxiety level
- Changes in quality of life
- Gut microbiota composition and functions
- Reduction of chemotherapy-related adverse events
- Adverse Events
研究者
研究点 (1)
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