RECRUITING

Wisconsin Ginseng for Decreasing Cancer Related Fatigue

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue. Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. American ginseng (Western ginseng) appears to be a promising appearing agent for treating cancer related fatigue. Western ginseng may reduce cancer-related fatigue.

Official Title

Phase III Study of Ginseng for Cancer Related Fatigue

Quick Facts

Study Start:2024-08-01

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06395441

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years * History of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale. Patients can answer questions orally rather than completing worksheet * Baseline control of insomnia: Insomnia ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet * Baseline control of pain: Pain ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet * Life expectancy ≥ 6 months * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Hemoglobin ≥ 10.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion) (≤ 180 days prior to registration) * Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit normal (ULN) (≤ 180 days prior to registration) * Creatinine ≤ 1.5 x ULN (≤ 180 days prior to registration) * No clinical suspicion of hypothyroidism within 180 days prior to registration \[if clinical suspicion of hypothyroidism exists, a documented thyroid stimulating hormone (TSH) \< 5 milli-international units per liter (mIU/L) is required\] * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only * Ability to complete questionnaire(s) by themselves or with assistance * Provide informed consent	* Any known hypersensitivity to ginseng * Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 30 days and plan to continue such for 8 weeks. Exercise is allowed * Psychiatric disorder such as poorly controlled depression, manic depressive disorder, obsessive compulsive disorder, or schizophrenia (defined per medical history) * Use of erythropoietic agents ≤ 6 months * Uncontrolled hypertension on more than three occasions (diastolic blood pressure ≥ 100, systolic ≥ 160) measured ≤ 180 days prior to randomization * Surgery that required general anesthetic ≤ 30 days prior to randomization * Malnutrition, active infection, severe depression, or significant pulmonary disease and cardiovascular disease (as determined by the attending clinician), as they could impact fatigue * Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, Rhodiola rosea, guarana, or anything called an "adaptogen") * Currently using an antidiabetic drug, warfarin or monamine oxide inhibitor * Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years
* History of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale. Patients can answer questions orally rather than completing worksheet
* Baseline control of insomnia: Insomnia ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet
* Baseline control of pain: Pain ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet
* Life expectancy ≥ 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Hemoglobin ≥ 10.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion) (≤ 180 days prior to registration)
* Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit normal (ULN) (≤ 180 days prior to registration)
* Creatinine ≤ 1.5 x ULN (≤ 180 days prior to registration)
* No clinical suspicion of hypothyroidism within 180 days prior to registration \[if clinical suspicion of hypothyroidism exists, a documented thyroid stimulating hormone (TSH) \< 5 milli-international units per liter (mIU/L) is required\]
* Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
* Ability to complete questionnaire(s) by themselves or with assistance
* Provide informed consent

* Any known hypersensitivity to ginseng
* Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 30 days and plan to continue such for 8 weeks. Exercise is allowed
* Psychiatric disorder such as poorly controlled depression, manic depressive disorder, obsessive compulsive disorder, or schizophrenia (defined per medical history)
* Use of erythropoietic agents ≤ 6 months
* Uncontrolled hypertension on more than three occasions (diastolic blood pressure ≥ 100, systolic ≥ 160) measured ≤ 180 days prior to randomization
* Surgery that required general anesthetic ≤ 30 days prior to randomization
* Malnutrition, active infection, severe depression, or significant pulmonary disease and cardiovascular disease (as determined by the attending clinician), as they could impact fatigue
* Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, Rhodiola rosea, guarana, or anything called an "adaptogen")
* Currently using an antidiabetic drug, warfarin or monamine oxide inhibitor
* Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)

Contacts and Locations

Principal Investigator

Daniel S. Childs, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Daniel S. Childs, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-08-01

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm