Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
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.
Detailed description
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). II. To observe the relationship of L-theanine on mood states as measured by Short Form of the Profile of Mood States (POMS-SF). EXPLORATORY OBJECTIVES: I. To determine the feasibility of L-theanine use among cancer patients in surveillance based on recruitment. II. To observe the relationship of L-theanine in supporting sleep among cancer patients in surveillance as measured by the Pittsburgh Sleep Quality Index (PSQI). III. To describe the side effects of L-theanine supplementation. IV. To observe the relationship between L-theanine on symptom burden among cancer patients in surveillance as measured by Edmonton Symptom Assessment Scale (ESAS). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive L-theanine orally (PO) once daily (QD) for 6 weeks in the absence of unacceptable toxicity. ARM II: Patients receive L-theanine PO twice daily (BID) for 6 weeks in the absence of unacceptable toxicity. After completion of study intervention, patients are followed up at 14 days.
Interventions
OTHERSurvey Administration
Ancillary studies
DRUGTheanine
Given L-theanine PO
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence rates | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-perceived anxiety | From screening to day 42 | Assessed via Visual Analog Scale-Anxiety. Within-group mean changes will be examined using paired t-tests (comparing any two time points of interest). Between-group mean changes will be evaluated at each time point using independent-samples t-tests. |
| Anxiety and depression | From baseline to day 42 | Assessed via Hospital Anxiety and Depression Scale. Within-group mean changes will be examined using paired t-tests (comparing any two time points of interest). Between-group mean changes will be evaluated at each time point using independent-samples t-tests. |
| Transient mood states | From baseline to day 42 | Assessed via Short Form of the Profile of Mood States that includes tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Within-group mean changes will be examined using paired t-tests (comparing any two time points of interest). Between-group mean changes will be evaluated at each time point using independent-samples t-tests. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErica Veguilla
City of Hope Medical Center
Outcome results
None listed