Tongue Cancer Clinical Trial
Official title:
Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer
This pilot clinical trial studies freeze-dried black raspberries (BRB) in preventing oral cancer recurrence in high at-risk Appalachian patients previously treated with surgery for oral cancer. Chemoprevention is the use of drugs natural products to keep cancer from developing, progressing, or recurring. Giving freeze-dried black raspberries may prevent oral cancer from forming or returning in oral cancer survivors.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01469429 -
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04041141 -
Oral Stent Device for Radiation Treatments of Oral Cancers
|
||
| Completed |
NCT00049283 -
Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00407810 -
Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00096512 -
S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT01637194 -
Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00033618 -
Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck
|
Phase 2 | |
| Completed |
NCT01816841 -
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
|
N/A | |
| Recruiting |
NCT04028479 -
The Registry of Oncology Outcomes Associated With Testing and Treatment
|
||
| Completed |
NCT04059861 -
Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin
|
N/A | |
| Recruiting |
NCT01854021 -
Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
|
N/A | |
| Completed |
NCT01816984 -
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT01674374 -
Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy
|
Phase 2 | |
| Terminated |
NCT01528137 -
Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT04337853 -
Radiotherapy of Tongue Cancer Using an Intraoral Stent
|
Phase 1 | |
| Completed |
NCT01806675 -
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01847326 -
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer
|
Phase 1 | |
| Terminated |
NCT02177838 -
Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer
|
N/A | |
| Completed |
NCT00114283 -
Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT04126226 -
Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy
|
N/A |