SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- percentage of participants with hair loss
研究概览
简要总结
The goal of this interventional study is to determine if scalp cooling (by the Paxman Scalp Cooling System) reduces the extent and severity of alopecia in participants with advanced solid tumours receiving ADC.
The main question it aims to evaluate the efficacy of scalp cooling in reducing chemotherapy-induced alopecia in participants with advanced/metastatic solid tumours receiving antibody-drug conjugates (trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan), as assessed by blinded central dermatological review.
Researchers will compare the experimental arm (ADC treatment + scalp cooling) with the control arm (ADC only). Scalp cooling will be done each day of ADC treatment : before, during and post-infusions of their ADC treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Dermatologists Committee who will centrally assess alopecia (providing SALT score)
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
- •Age ≥ 18 years
- •ECOG performance status (PS) 0-2
- •Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE < 2)
- •Participants with histologically or cytologically confirmed advanced or metastatic solid tumour
- •Planned initiation of standard of care antibody-drug conjugate (namely, trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan) at any clinically appropriate dose and schedule
- •Life expectancy > 6 months
- •Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- •Participant is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
排除标准
- •Known pregnant and/or lactating women.
- •Participant with a known significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study
- •Active haematological malignancy diagnosis
- •Known or suspected scalp metastases at screening
- •Planned concurrent alopecia-inducing therapy during ADC treatment (e.g. whole-brain radiotherapy or cytotoxic chemotherapy)
- •History of cold intolerance syndromes (e.g. cryoglobulinaemia, cold agglutinin disease, or cold urticaria)
- •Active scalp dermatological disease likely to interfere with cooling or assessments (e.g. lupus erythematosus, lichen planus)
- •Known hypersensitivity to device cap materials or coolant
- •Uncontrolled migraine or chronic headache disorders worsened by cold exposure, in the investigator's judgement
- •Participants who have already started treatment with an ADC prior to randomisation will be excluded, as scalp cooling must begin with the first ADC infusion
研究组 & 干预措施
Control
Observation
干预措施: Antibody-Drug Conjugates (Drug)
Experimental
Scalp cooling
干预措施: scalp cooling (Device)
Experimental
Scalp cooling
干预措施: photographs via the Belle.AI app (Other)
Experimental
Scalp cooling
干预措施: Antibody-Drug Conjugates (Drug)
Control
Observation
干预措施: photographs via the Belle.AI app (Other)
结局指标
主要结局
percentage of participants with hair loss
时间窗: 3 months
defined as the Severity of Alopecia Tool (SALT) score greater than zero The SALT score is calculated as follows: 1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital. 2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.). 3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss. assessed by blinded central dermatological review.
次要结局
- degree of hair loss(3 months)
- Change from baseline in quality of life(at each cycle of treatment + 28 days following end of treatment)
- Change from baseline in quality of life(at each cycle of treatment + 28 days after the end of treatment)
- Frequency, and severity of adverse events related to scalp cooling(all along study : from first day of treatment until 6 months follow up after the last administration of study treatment or before starting any new anticancer treatment, whichever comes first)
- compare scalp hair loss assessment across three methods(3 months)