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New treatment option for Hematopoietic and Lymphatic System Neoplasm
Official title L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance
ClinicalTrials.gov ID: NCT07220447
What this study is testing
What is Theanine?
Theanine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hematopoietic and lymphatic system neoplasm.
Also referred to as L-theanine, N-Ethyl-L-Glutamine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Concurrent use of other alternative medicines, including herbal agents and high-dose vitamins and minerals, unless taken to correct a documented...
- Chemotherapy, radiation therapy, biological therapy, immunotherapy, or any other systemic treatment excluding hormonal therapy (must be on a stable...
- Any patients taking bortezomib, as L-theanine can decrease how well it works
- 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...
See the full eligibility criteria
- 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...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- 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 how well it works
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Huntington Beach, California, United States; Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.