Clinical trial · Interventional
L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance
Investigating the Feasibility and Relationship of L-Theanine in Supporting Relaxation and Mood in Cancer Patients in Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey Administration | Other | — | UNRESOLVED |
| Theanine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (L-theanine QD)
- description
- Patients receive L-theanine PO QD for 6 weeks in the absence of unacceptable toxicity.
- interventionNames
- Other: Survey Administration
- Drug: Theanine
- type
- EXPERIMENTAL
- label
- Arm II (L-theanine BID)
- description
- Patients receive L-theanine PO BID for 6 weeks in the absence of unacceptable toxicity.
- interventionNames
- Other: Survey Administration
- Drug: Theanine
Primary outcomes (2)
- measure
- Adherence rates
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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 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) Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available