Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors
Ключови думи
Резюме
Описание
PRIMARY OBJECTIVES:
I. To conduct an initial early phase clinical study utilizing a high ar-risk and underserved Appalachian population who are former oral cancer patients to determine the practicability of long-term daily freeze-dried black raspberry (BRB) (BRB lozenge) administration and to gain insights into the potential prevention of recurrent oral cancer by BRBs.
SECONDARY OBJECTIVES:
I. Evaluate numerous parameters (recruitment, tolerability, adherence to study guidelines, collection of biological samples, and demographics) that will be helpful in designing a future definitive, randomized, Phase II or III clinical trial structured to assess the potential effects of long-term BRB administration.
II. Evaluate the temporal modulation of BRB-responsive gene expression that favor oral cancer chemoprevention in high at-at risk normal tissues before and after BRB administration.
III. Assess the temporal modulation of BRB-responsive gene expression and biological levels of fruit components in post-surgical oral cancer patients not exposed to BRBs.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients receive freeze-dried black raspberry lozenges orally (PO) 4 times daily (QID) for up to 6 months.
ARM II: Patients do not receive freeze-dried black raspberries lozenges.
After completion of study treatment, patients in Arm I are followed for up to 5 years and patients in Arm II are followed for up to 1 year for oral cancer recurrence.
Дати
| Последна проверка: | 01/31/2020 |
| Първо изпратено: | 12/14/2011 |
| Очаквано записване подадено: | 01/02/2012 |
| Първо публикувано: | 01/05/2012 |
| Изпратена последна актуализация: | 02/17/2020 |
| Последна актуализация публикувана: | 02/19/2020 |
| Действителна начална дата на проучването: | 02/22/2007 |
| Приблизителна дата на първично завършване: | 04/21/2015 |
| Очаквана дата на завършване на проучването: | 04/21/2015 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Arm I: BRB Lozenge
Other: Survey Administration
Other: Laboratory Biomarker Analysis
Other: pharmacological study
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Arm I: BRB Lozenge Former oral cancer patients receive lozenges containing freeze-dried black raspberry (BRB) powder. They will take the lozenges four times each day (QID) by mouth (PO) for up to 6 months.
Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey.
They will receive a trial-specific logbook to record their usages.
Intervention: Black Raspberry (BRB) Lozenge Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis | Dietary Supplement: Arm I: BRB Lozenge ARM I: Patients will be instructed to begin BRB administration and continue daily for up to 6 months. |
| Other: Arm II: Biomarker Control Former oral cancer patients will not receive lozenges containing freeze-dried black raspberry (BRB) powder.
Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey.
They will receive a trial-specific logbook to record their usages.
Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 21 Years Да се 21 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. Time to recurrence [Up to 5 years]
Вторични изходни мерки
1. Adherence rates in patients receiving LBR [Up to 5 years]
2. LBR-responsive gene expression before, during, and after LBR administration (Arm I) [Up to 5 years]
3. LBR-responsive gene expression in patients not exposed to LBR (Arm II) [Up to 5 years]
4. LBR responsive gene activity and time to recurrence [Up to 5 years]
