Nutrition and Inflammation in Patients with Head and Neck Cancer

NCT03343236 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 522

Last updated 2024-12-13

No results posted yet for this study

Summary

An estimated 1500 people in Sweden will annually be diagnosed with head and neck cancer (HNC). Five year survival is approximately 69%. Long-term sequelae are common and in particular nutritional problems and fatigue. Radiotherapy (RT) is the cornerstone of treatment, either as single modality treatment or combined modality treatment. RT can induce immune responses at the site of tumor. It has been demonstrated that RT can lead to a strong systemic immune response . We have previously shown that an increase of conventional measures of systemic immune response to RT varied significantly across individuals. We predict that local immune response plays a major role in the antitumor effect. We also predict that a strong systemic immune response contributes to malnutrition and influence on survival. And malnutrition may lead to a worse response to RT.

The overall aim of this multicenter observational longitudinal study is to prospectively identify immunological and metabolic variables that affect the outcome of HNC patients. We will systematically investigate the local and systemic immune response induced by RT as well as explore alterations in metabolite composition induced by disease and treatment through global metabolite profiling. A platform for studies on immuno-metabolic changes in HNC patients has been established in the Uppsala-Orebro and Northern regions. Approximately 370 patients per year are eligible. Findings in this study can have implications on the development of personalized therapy in patients with HNC. The long-term benefit of the study will be the identification of measures for improved patient surveillance in order to improve the general and nutritional outcomes.

Conditions

  • Head and Neck Neoplasms
  • Radiotherapy Side Effect
  • Inflammation
  • Metabolism

Interventions

RADIATION

Radiotherapy

All patients will undergo radiotherapy or surgery, or combined modality treatment

Sponsors & Collaborators

  • Swedish Cancer Society

    collaborator OTHER
  • The Kamprad Family Foundation for Entrepreneurship, Research & Charity

    collaborator OTHER
  • AFA Insurance

    collaborator INDUSTRY
  • Uppsala University

    lead OTHER

Principal Investigators

  • Goran FE Laurell, Professor · Department of Otolaryngology, Head & Neck Surgery, Uppsala University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03343236 on ClinicalTrials.gov