Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis
ConditionHead and Neck Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro di Riferimento Oncologico - Aviano
About this trial
The goal of this observational study is to learn about relation between vitamin D levels in subjects with head and neck cancer. The main question it aims to answer are:
* variation of vitamin D levels in the study population at different time points * relation between therapy side effects and vitamin D level * relation between disease outcome and vitamin D level Participants will be followed as per clinical practice
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
non-metastatic locally advanced stages
patients candidate for radical or adjuvant radiotherapy
patients candidate for bilateral neck irradiation
written informed consent
Disqualifiers
distant metastases
patients with known disorders of calcium/vitamin D metabolism
Trial population
Patients of the participant centers with histologically proven HNSCC (squamous cell carcinomas)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
953 Participants
are grouped into 1 trial groupGroup A: Head and Neck cancer patients
Trial outcomes
Primary outcomes
1
Vitamin D variation
Difference in vitamin D levels between baseline and during radiotherapy
Time frame
7 weeksSecondary outcomes
1
Baseline vitamin D level and radiotherapy toxicity
Evaluation of the impact of baseline vitamin D levels on acute toxicity (mucositis, dermatitis and weight loss \>10%)
Time frame
8 weeks2
Baseline vitamin D level and response
Evaluation of the impact of baseline vitamin D levels on response measured in term of ORR (Objective Response Rate)
Time frame
12 weeks3
Baseline vitamin D level and relapse free survival
Impact of baseline vitamin D levels on relapse free survival
Time frame
up to 2 years4
Baseline vitamin D level and survival
Impact of baseline vitamin D levels on overall survival
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov