- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01576939
Feasibility of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer
A Feasibility Study of IMRT (Intensity Modulated Radiotherapy) Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer Patients
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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California
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Stanford, California, Vereinigte Staaten, 94305
- Stanford University School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patients with HNC undergoing radiation therapy +/- chemotherapy at Stanford University
- At least 18 years old
- Metallic filling present
- Planned radiation dose to the tumor > 60 Gy at 1.8 to 2.2 Gy/fx
- Able to understand and sign a written informed consent document.
Exclusion Criteria:
- Pregnant
- Nursing
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: IMRT Modulation
All patients will undergo a computed tomography (CT) simulation study +/- a positron emission tomography (PET) scan using ≤ 3mm slices for radiation treatment planning. A standard, "non-filling" optimized IMRT (Intensity Modulated Radiation Therapy) plan will be generated and patients will be treated with megavoltage radiation over a course of > 6 weeks with a planned tumor dose of > 60 Gy. A medical doctor will perform weekly mucositis evaluation and grading for the measured site once a week during radiation therapy Modulation of an IMRT plan to reduce the dose to less than 35 Gy delivered to adjacent normal mucosa surrounding the dental filling without compromising normal tissue or tumor doses. |
We are using thermoluminescent dosimeter (TLD) to measure the mucosal dose adjacent to the dental fillings in a standard, "non-filling" optimized IMRT (intensity modulated radiotherapy treatment) plan that is normally delivered in the clinic.
If the measured mucosal dose exceeds 35 Gy, we will generate a "filling" optimized IMRT plan to reduce it to < 35 Gy.
The new plan will be deemed acceptable and implemented only if it does not (1) compromise the tumor coverage, (2) increase the dose to either the remaining oral cavity or the spared parotid gland(s).
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment.
Zeitfenster: 3 years
|
The time to onset of oral mucositis was measured from the start of radiation treatment until oral mucositis was visual observed by a clinician during the weekly checkup for the first time. Analysis done by Kaplan-Meier. Adverse events were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version (V) 4.0. Medical doctor performed evaluation and grading of clinical and functional mucositis for the measured site weekly during the radiation treatment course and biweekly after completion of radiation until oral mucositis was < grade 2. A pain medication assessment was done for each mucositis time point. Patients completed the Oral Mucositis Weekly Questionnaire-Head and Neck cancer (OMWQ-HN) during and after treatment until oral mucositis is < grade 2. |
3 years
|
Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed.
Zeitfenster: 3 years
|
The duration of grade 2 or higher oral mucositis was measured as the time from the first time oral mucositis was observed by a clinician at the weekly checkup until the oral mucositis was resolved. The data was analyzed in a mixed effects model to account for the within subject correlation, since each patient contributed two measurements to the data set. The model was limited to those subjects who had experienced mucositis and then the outcome was the duration of grade 2 or higher mucositis. This allowed us to model the data in a mixed effects model with the continuous outcome of duration of grade 2 or higher mucositis. |
3 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use
Zeitfenster: 3 years
|
The narcotics use was a patient reported measurement that was documented in the medical note in the patient chart.
Patient self reported measurements are generally known to be unreliable.
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3 years
|
How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose
Zeitfenster: 3 years
|
The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMWQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping. This outcome measures soreness in both the mouth and throat. This outcome is not a combination of several sub-scales. This outcome was the response to the single question: "On a scale from 0 to 10, how would you rate your OVERALL MOUTH AND THROAT SORENESS during the past 24 hours?" Mouth and throat soreness was measured as a single scale from 0 (no soreness) to 10 (worst soreness possible). |
3 years
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How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose?
Zeitfenster: 3 years
|
The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMDQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping. This outcome measures pain in the mouth only. This outcome is not a combination of several sub-scales. This outcome was the response to a single question: "On a scale from 0 to 10, what number best describes the MOUTH PAIN that you experienced in the past 24 hours?" Mouth pain scale was measured as a single scale from 0 (no pain) to 10 (worst pain imaginable). |
3 years
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Quynh-Thu Le, MD, Professor of Radiation Oncology
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB-21777
- SU-08102011-8266 (Andere Kennung: Stanford University)
- ENT0032 (Andere Kennung: OnCore)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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