Nutrition and Inflammation in Patients with Head and Neck Cancer

NCT03343236 | Active Not Recruiting

• 1 other identifier: 160451
• Study Type: observational
• Target: 522
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Head and neck cancer; Observational study; Three tertiary hospitals; Long-term follow-up; Survival; Immune response; Metabolomics

Outcome Measures

Primary Outcomes (3)

• Pro-inflammatory cytokines in serum

  IL-6

  Change from baseline of pro-inflammatory cytokines in serum at 7 weeks

• Pro-inflammatory cytokines in serum

  IL-6

  Change from baseline of pro-inflammatory cytokines at 3 months

• Pro-inflammatory cytokines in serum

  IL-6

  Change from baseline of pro-inflammatory cytokines at 12 months

Secondary Outcomes (6)

• Fatty acids in serum

  Change from baseline of fatty acids at 7 weeks

• Fatty acids in serum

  Change from baseline of fatty acids at 3 months

• Fatty acids in serum

  Change from baseline of fatty acids at 12 months

• Weight

  Change from baseline of weight to 7 weeks

• Weight

  Change from baseline of weight to 3 months

Study Arms (1)

Patients with head and neck cancer

All patients with newly diagnosed and untreated head and neck cancer. Exclusion criteria: previous treatment for malignant disorder except for skin cancer, severe alcohol abuse, psychiatric disorder, inability to understand Swedish

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

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

Also known as: Surgery

Patients with head and neck cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with head and neck cancer at the following three university hospitals: Uppsala University Hospital, Orebro University Hospital, Umea University Hospital

You may qualify if:

• Patients with newly diagnosed head and neck cancer

You may not qualify if:

• Previous treatment for malignant disease except for skin cancer, severe alcohol abuse, psychiatric disorder, inability to understand Swedish

Sponsors & Collaborators

• Uppsala University: lead
• Swedish Cancer Society: collaborator
• The Kamprad Family Foundation for Entrepreneurship, Research & Charity: collaborator
• AFA Insurance: collaborator

Study Sites (1)

Department of Otolaryngology, Head & Neck Surgery, Uppsala University Hospital

Uppsala, SE-75185, Sweden

Location

Related Publications (16)

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• Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen JF, Biorklund A, de Leeuw JR, Fayers PM, Jannert M, Westin T, Kaasa S. Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol. 1999 Mar;17(3):1008-19. doi: 10.1200/JCO.1999.17.3.1008.

  PMID: 10071296 BACKGROUND

• Tiblom Ehrsson Y, Einarsson S, Fransson P, Laurell G. Swedish Translation and Cultural Adaptation of the Head and Neck Patient Symptom Checklist: An Instrument to Screen for Nutrition Impact Symptoms in Clinical Practice and Research. West J Nurs Res. 2024 Oct;46(10):790-798. doi: 10.1177/01939459241274342. Epub 2024 Aug 24.

  PMID: 39180372 DERIVED

• Einarsson S, Bokstrom A, Laurell G, Tiblom Ehrsson Y. Mapping the impact of malnutrition as defined by the Global Leadership Initiative on Malnutrition and nutrition impact symptoms on the possibility of returning to work after treatment for head and neck cancer. Support Care Cancer. 2023 Dec 22;32(1):55. doi: 10.1007/s00520-023-08252-x.

  PMID: 38133825 DERIVED

• Granstrom B, Holmlund T, Laurell G, Fransson P, Tiblom Ehrsson Y. Addressing symptoms that affect patients' eating according to the Head and Neck Patient Symptom Checklist(c). Support Care Cancer. 2022 Jul;30(7):6163-6173. doi: 10.1007/s00520-022-07038-x. Epub 2022 Apr 15.

  PMID: 35426524 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample, tumor biopsy

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Injuries; Inflammation

Interventions

Radiotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Goran FE Laurell, Professor

  Department of Otolaryngology, Head & Neck Surgery, Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: November 1, 2015
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)