Investigating the Feasibility and Relationship of L-Theanine in Supporting Relaxation and Mood in Cancer Patients in Surveillance
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Adherence rates
研究概览
简要总结
This clinical trial tests the feasibility, best dose, and effectiveness of L-theanine for supporting relaxation and mood among cancer patients in surveillance. L-theanine is a substance found in the leaves of green tea with potential to enhance mental health and well-being. It works by increasing certain chemicals within the body that have been associated with stress reduction, mood stabilization, and improved cognitive performance.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of L-theanine use among cancer patients in surveillance based on adherence.
II. To determine the relationship of L-theanine on relaxation and supporting mood among cancer patients in surveillance with a dose of 200mg once daily versus (vs) twice daily, as measured by Visual Analog Scale-Relaxation (VAS-R).
SECONDARY OBJECTIVES:
I. To observe the relationship of L-theanine in reducing anxiety among cancer patients in surveillance, as measured by Visual Analog Scale-Anxiety (VAS-A).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented informed consent of the participant and/or legally authorized representative.
- •Assent, when appropriate, will be obtained per institutional guidelines
- •Willingness to comply with all study interventions including the use of L-theanine and follow-up assessments
- •Age: ≥ 18 years
- •Ability to read and understand English or Spanish for questionnaires
- •Patients must be a cancer patient who has completed treatment and has been in surveillance for at least 6 months
- •Participants must not have used any herbs or supplements in the past 30 days
- •Participants must report an anxiety score of > 3 on Visual Analog Scale - Anxiety
- •Participants must not have had any changes to their psychiatric medications within the past 60 days
- •Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy.
- •Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
排除标准
- •Concurrent use of other alternative medicines, including herbal agents and high-dose vitamins and minerals, unless taken to correct a documented vitamin or mineral insufficiency
- •Chemotherapy, radiation therapy, biological therapy, immunotherapy, or any other systemic treatment excluding hormonal therapy (must be on a stable dose of hormonal therapy for at least 60 days)
- •Any patients taking bortezomib, as L-theanine can decrease effectiveness
- •Any patients currently enrolled in other clinical trials that might interfere with the results of this study
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- •Any patients with an ongoing active/unstable psychiatric condition, depressive/bi-polar related disorders, anxiety, psychosis disorders, or substance use that may interfere with the ability to participate in the study as outlined in the study procedures section of the protocol
- •Any patients with chronically unstable blood pressure or chronic low blood pressure
- •Diagnosis of Gilbert's disease
- •Females only: Pregnant or breastfeeding
- •Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
研究组 & 干预措施
Arm I (L-theanine QD)
Patients receive L-theanine PO QD for 6 weeks in the absence of unacceptable toxicity.
干预措施: Theanine (Drug)
Arm I (L-theanine QD)
Patients receive L-theanine PO QD for 6 weeks in the absence of unacceptable toxicity.
干预措施: Survey Administration (Other)
Arm II (L-theanine BID)
Patients receive L-theanine PO BID for 6 weeks in the absence of unacceptable toxicity.
干预措施: Theanine (Drug)
Arm II (L-theanine BID)
Patients receive L-theanine PO BID for 6 weeks in the absence of unacceptable toxicity.
干预措施: Survey Administration (Other)
结局指标
主要结局
Adherence rates
时间窗: Up to 8 weeks
Will consider the study feasible if at least 75% of enrolled participants adhere to the planned intervention. Adherence will be defined as having at least 75% study drug accountability. Will be estimated along with the 95% exact binomial confidence interval.
Perceived levels of relaxation
时间窗: From baseline to day 42
Measured via Visual Analog Scale-Relaxation (VAS-R). Response is defined as a favorable change of at least 1.5 points on the VAS-R. Will be estimated along with the 95% exact binomial confidence interval. Within-group mean changes in VAS-R will be examined using paired t-tests (comparing any two time points of interest).
次要结局
- Self-perceived anxiety(From screening to day 42)
- Anxiety and depression(From baseline to day 42)
- Transient mood states(From baseline to day 42)