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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01504932
Eligibility Criteria:
Inclusion Criteria:
* Patients from any Appalachian County with previously diagnosed, biopsy-proven, surgically resected, oral squamous cell carcinoma (SCC) (stages T1 to T4), which encompasses cancers of the oral cavity including lips, buccal mucosa, teeth, floor of the mouth and gums and those of the oropharynx consisting of the base of the tongue, soft palate, tonsillar area, and the posterior pharyngeal wall will be eligible
* Patients who have followed the advice of their physician and have been definitively treated for their tumor by any method and are currently disease free will be eligible
* Patients may be enrolled as early as their first follow-up post-operative clinic visit after their most recent surgery, but no more than 36 months post-surgery
* Patients must be able to take nutrition/medications orally
* No prior history of intolerance or allergy to berry or berry-containing products
Exclusion Criteria:
* History of intolerance (including hypersensitivity or allergy) to berry or berry-containing products
* Patients who are actively receiving adjuvant therapy (radiation, chemotherapy) will be excluded until such time as they have completed treatments
* Pregnant women; although there are no known adverse effects of black raspberries upon the fetus, if patients become pregnant during period of LBR administration, then LBR will be discontinued and patient will be removed from the study
* Inability to grant informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01504932
Study Brief:
Protocol Section:
NCT01504932