Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT01668849|
Recruitment Status : Active, not recruiting
First Posted : August 20, 2012
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Oral Mucositis||Dietary Supplement: Grape extract Drug: Lortab, Fentanyl patch, mouthwash||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Abrogate Oral Mucositis Induced by Combined Chemotherapy and Radiation in Head and Neck Cancer Patients|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: 1 - Grape extract
Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
Dietary Supplement: Grape extract
Grape extract self-administered by mouth daily for 35 days
Active Comparator: 2 - Lortab, Fentanyl patch, mouthwash
Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.
Drug: Lortab, Fentanyl patch, mouthwash
Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
- Pain caused by oral mucositis [ Time Frame: Total followup of six months ]Extent of pain from oral mucositis will be evaluated weekly during treatment (6 to 7 weeks) and for six months following the completion of treatment which will last approximately 30 days.
- Level of immune biomarkers in blood [ Time Frame: Within three days of the completion of radiation therapy which will last approximately 30 days. ]Levels of immune biomarkers (cytokines, T cells NK Cells CD11cIL12)in the blood at the time of completion of radiation therapy will be compared to baseline levels.
- Level of immune biomarkers in mucosal tissue [ Time Frame: Within three days of the completion of radiation therapy which will last approximately thirty days. ]Levels of immune biomarkers (CD3, CD8, CD11b, F4/80, BRDU)in scrapings of mucosal tissue at the time of completion of radiation therapy will be compared to baseline levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668849
|United States, Kentucky|
|James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Rebecca Redman, MD||James Graham Brown Cancer Center, University of Louisville|