Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT01668849|
Recruitment Status : Active, not recruiting
First Posted : August 20, 2012
Last Update Posted : January 30, 2018
|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 2018|
|Estimated Study Completion Date :||August 2018|
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.
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|