Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero… (NCT01548846) | Clinical Trial Compass
TerminatedPhase 2
Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract
Stopped: lack of recrutment
France11 participantsStarted 2012-05
Plain-language summary
This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient (e) old (e) over 18 years
* Patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven.
* Patient targeted for head and neck radiotherapy by Tomotherapy exclusive with or without concurrent chemotherapy (containing platinum)
* Indication of head and neck radiotherapy bilateral
* All of the TNM stage except metastatic
* Patient has signed informed consent for participation in the study
* Mastery of the French language
Exclusion Criteria:
* History of head and neck radiotherapy
* Indication of head and neck radiotherapy unilateral
* Personal history of malignant tumors uncontrolled over the past 5 years
* History of oral sicca syndrome
* Surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland)
* Concomitant treatment with amifostine
* Concomitant treatment with cetuximab
* Primary tumor of the salivary glands
* Head and neck hyperfractionated radiotherapy and / or accelerated
* Head and neck radiotherapy hypofractionated
* Metastatic disease
* Patient deprived of liberty, under guardianship
* Any medical condition or psychological associate that could compromise the patient's ability to participate in the study
* Refusal of the patient.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the proportion of patients with xerostomia
Timeframe: 12 months after completion of radiotherapy.