Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04495751
Eligibility Criteria:
Inclusion Criteria:
* Self-reported history of cancer diagnosed \> 12 months prior to enrollment excluding non-melanoma skin cancer with no evidence of disease at enrollment.
* Eligible solid tumor cancer types include Stage 1-3 breast, lung, head and neck, colorectal, anal, prostate, melanoma, bladder/ureteral, esophageal, gastric, pancreatic, kidney, liver/biliary, uterine, cervical, ovarian, sarcoma. (superficial disease and in situ disease only is excluded)
* Eligible hematologic malignancies include lymphoma any subtype any stage in remission, multiple myeloma in remission, leukemia any subtype in remission.
* Eligible prior cancer treatment modalities include surgery, radiation, chemotherapy, hormonal therapies, immunotherapy, biologic therapies.
* All anti-cancer therapy completed \> 12 months prior to enrollment
* Age 65 years and older
* Presence of self-reported fatigue defined by a response of "somewhat, quite a bit or very much" to the screening question "During the past seven days, did you feel fatigued: Not at all, a little bit, somewhat, quite a bit, very much?"
* Ability to walk without requiring assistance from another individual (use of cane or walker acceptable)
* Normal organ and marrow function as defined below:
* leukocytes \>3,000/mcL
* absolute neutrophil count \>1,500/mcL
* platelets \>100,000/mcL
* total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
* creatinine clearance \>30 mL/min
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Exclusion Criteria:
* Active malignancy or on-going cancer treatment including oral anti-estrogen therapy, immunotherapy, biologic therapy.
* Men receiving androgen deprivation therapy
* Use of Coumadin or Warfarin (other blood thinners are acceptable)
* Symptomatic congestive heart failure
* Lung disease requiring oxygen
* End stage renal disease requiring dialysis
* Inability to swallow capsules
* Chronic nausea or diarrhea defined by a frequency of ≥ once per week
* Hemoglobin \<10 g/dl
* Diagnosis of dementia
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Known untreated hypothyroidism
* Allergy to muscadine grapes or muscadine grape preparations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04495751
Study Brief:
Protocol Section:
NCT04495751