Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis
A Pilot Study to Evaluate the Role of Cyclooxygenase Pathway in Radiation Therapy and Chemoradiation Therapy Induced Mucositis in Head and Neck Cancer Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Oral mucositis is a significant toxicity of radiation therapy and chemoradiation therapy in head and neck cancer patients. However the mechanisms that induce such mucositis are not completely understood. Previous work evaluating mucositis in bone marrow transplant patients has suggested that prostaglandin levels may be associated with the appearance of mucositis.
The present study will measure the levels in saliva of the prostaglandins PGE2 and PGI2 before, during, immediately after, and several weeks after radiotherapy for head and neck cancer. These salivary levels will be correlated with clinical observation of mucositis and patient reporting of pain levels.
Improved understanding of the mechanism of mucositis may lead to the development of more effective targeted agents to prevent this problem.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
- Receiving radiation therapy or chemoradiation therapy to the oropharynx
- Older than 18 years old
- ECOG performance status of 0-2
- Life expectancy greater than 2 months
- Signed informed consent
Exclusion Criteria:
- Previous chemotherapy for this malignancy
- Previous radiotherapy to the head and neck
- Other cancer diagnosis within the last 5 years except for non-melanoma skin cancer or non-metastatic prostate cancer
- Patient taking NSAIDs
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Radiotherapy
Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Salivary levels of PGE2 and PGI2 during and after radiotherapy
Tidsramme: 10 weeks after initiation of therapy
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10 weeks after initiation of therapy
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Observed mucositis during and after radiotherapy
Tidsramme: 10 weeks after initiation of radiotherapy
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10 weeks after initiation of radiotherapy
|
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Patient reports of oral pain during and after radiation therapy
Tidsramme: 10 weeks after initiation of radiotherapy
|
10 weeks after initiation of radiotherapy
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Claire Verschraegen, MD, University of Vermont/Fletcher Allen Health Care
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VCC1005
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