MICRO-VERZ: MICRObiome Changes During VERZenio Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Abemaciclib (Verzenio) is a commonly used treatment for hormone receptor-positive breast cancer, but it can cause gastrointestinal side effects such as diarrhea, which may affect quality of life and treatment tolerance. The gut microbiome, which is the collection of bacteria living in the digestive tract, may play a role in these symptoms.
The purpose of this study is to examine how the gut microbiome changes during the early phase of abemaciclib treatment and how these changes relate to gastrointestinal symptoms experienced by patients. Participants will provide stool samples at multiple time points using mailed collection kits and will complete questionnaires about gastrointestinal symptoms while receiving standard-of-care abemaciclib therapy. All study procedures will be conducted remotely.
Information gained from this study may help inform future supportive care strategies for breast cancer patients receiving abemaciclib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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.
- •Histologically confirmed hormone receptor-positive, HER2-negative breast cancer.
- •Planned initiation of adjuvant abemaciclib (Verzenio) as part of standard clinical care, with enrollment occurring prior to or within 7 days of starting abemaciclib.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Women of child-bearing potential must agree to use contraception prior to study entry, for the duration of study participation, and for 90 days following completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Concurrent participation in another interventional clinical trial that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
- •Known gastrointestinal conditions that would significantly interfere with study procedures or interpretation of results, including but not limited to inflammatory bowel disease, short bowel syndrome, or chronic diarrheal disorders.
- •Known allergy or intolerance to resistant starch or any component of the study supplement.
- •Pregnant or breastfeeding individuals.
- •Any medical, psychiatric, or social condition that, in the judgment of the investigator, would limit the participant's ability to comply with study procedures.
研究组 & 干预措施
Resistant Starch Intervention
Participants randomized to this arm will receive resistant starch powder as a dietary supplement during early abemaciclib therapy. The supplement will be taken orally as a powder mixed with a beverage, according to instructions provided. Participants will continue to receive abemaciclib as standard of care and will complete study procedures including stool sample collection and symptom questionnaires.
干预措施: Resistant Potato Starch (Dietary Supplement)
Placebo Supplementation (Control Arm)
Participants randomized to this arm will receive a placebo powder as a dietary supplement during early abemaciclib therapy. The placebo will be taken orally as a powder mixed with a beverage, according to instructions provided. Participants will continue to receive abemaciclib as standard of care and will complete study procedures including stool sample collection and symptom questionnaires.
干预措施: Placebo control (Dietary Supplement)
结局指标
主要结局
Recruitment rate
时间窗: From study opening through completion of enrollment (approximately 12 months)
Feasibility will be assessed by the proportion of eligible participants who enroll in the study out of those approached for participation.
Participant retention
时间窗: Through end of intervention (6 weeks)
Feasibility and acceptability will be assessed by the proportion of enrolled participants who complete the intervention period and final study assessments.
Supplement adherence
时间窗: During the 6-week intervention
Feasibility will be assessed by participant adherence to the assigned supplement, measured as the proportion of prescribed doses taken during the intervention period.
Completion of study procedures
时间窗: Baseline through end of intervention (6 weeks)
Feasibility will be assessed by the proportion of participants who complete protocol-specified stool sample collections and questionnaires.
次要结局
- Change in Gut Microbial Community Composition During Early Abemaciclib Therapy(Baseline through Week 6 of abemaciclib therapy)
- Correlation between gut microbiome diversity and gastrointestinal symptom severity(Baseline through Week 6 of abemaciclib therapy)
- Differences in Gut Microbial Community Composition Between Resistant Starch and Placebo Groups(Baseline through Week 6 of abemaciclib therapy)
研究者
Tracy Smith
Faculty Scientist
University of Vermont Medical Center