Clinical trial · Interventional
Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
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
NCT01668849CI-TRIAL-00060181completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Grape extract | Dietary Supplement | — | UNRESOLVED |
| Lortab, Fentanyl patch, mouthwash | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1 - Grape extract
- description
- Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
- interventionNames
- Dietary Supplement: Grape extract
- type
- ACTIVE_COMPARATOR
- label
- 2 - Lortab, Fentanyl patch, mouthwash
- description
- Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.
- interventionNames
- Drug: Lortab, Fentanyl patch, mouthwash
Primary outcomes (1)
- measure
- Pain caused by oral mucositis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have definitive diagnosis of head and neck cancer. * Concurrent chemoradiation treatment of the primary tumor must be an option for the newly diagnosed cancer. * Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines. * Absence of life limiting medical conditions * Ability to understand and willingness to sign a written informed consent document. * ECOG performance status 0, 1, or 2 (Karnofsky \> 60%). * Patients must have adequate bone marrow function. ANC \> 1000/microL and Platelet count \>100,000/microL * Age \>20 years Exclusion Criteria: * Known familial head and neck cancer syndrome * Pregnancy * Known HIV * Patients receiving immunosuppressive drugs * Inflammatory bowel disease * Active second malignancy in the last 5 years * Patients receiving any other investigational agent(s) * Patients who have received any prior chemotherapy or radiation therapy to the primary head and neck cancer
References
Publications (1)
- DERIVEDWu K, Xing F, Wu SY, Watabe K. Extracellular vesicles as emerging targets in cancer: Recent development from bench to bedside. Biochim Biophys Acta Rev Cancer. 2017 Dec;1868(2):538-563. doi: 10.1016/j.bbcan.2017.10.001. Epub 2017 Oct 18. PMID 29054476