Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutrition and Inflammation in Patients With Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343236
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : October 20, 2021
Sponsor:
Collaborators:
Swedish Cancer Society
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
Information provided by (Responsible Party):
Uppsala University

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.


Condition or disease Intervention/treatment
Head and Neck Neoplasms Radiotherapy Side Effect Inflammation Metabolism Radiation: Radiotherapy

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammation and Metabolism After Radiotherapy- Predictors of Survival in Patients With Head and Neck Cancer
Actual Study Start Date : November 1, 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
All patients will undergo radiotherapy or surgery, or combined modality treatment
Other Name: Surgery




Primary Outcome Measures :
  1. Pro-inflammatory cytokines in serum [ Time Frame: Change from baseline of pro-inflammatory cytokines in serum at 7 weeks ]
    IL-6

  2. Pro-inflammatory cytokines in serum [ Time Frame: Change from baseline of pro-inflammatory cytokines at 3 months ]
    IL-6

  3. Pro-inflammatory cytokines in serum [ Time Frame: Change from baseline of pro-inflammatory cytokines at 12 months ]
    IL-6


Secondary Outcome Measures :
  1. Fatty acids in serum [ Time Frame: Change from baseline of fatty acids at 7 weeks ]
    FA 14:0

  2. Fatty acids in serum [ Time Frame: Change from baseline of fatty acids at 3 months ]
    FA 14:0, FA 16:0, FA 18:0, FA 20:0

  3. Fatty acids in serum [ Time Frame: Change from baseline of fatty acids at 12 months ]
    FA 14:0

  4. Weight [ Time Frame: Change from baseline of weight to 7 weeks ]
    kilogram

  5. Weight [ Time Frame: Change from baseline of weight to 3 months ]
    kilogram

  6. Weight [ Time Frame: Change from baseline of weight at 12 months ]
    kilogram


Biospecimen Retention:   Samples With DNA
Blood sample, tumor biopsy


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

Patients with newly diagnosed head and neck cancer

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343236


Contacts
Layout table for location contacts
Contact: Goran FE Laurell, Professor, MD, PhD +46 186115363 ext +46 702854719 goran.laurell@surgsci.uu.se
Contact: Ylva M Tiblom Ehrsson, PhD +46 707747712 ylva.tiblom.ehrsson@surgsci.uu.se

Locations
Layout table for location information
Sweden
Department of Otolaryngology, Head & Neck Surgery, Uppsala University Hospital Recruiting
Uppsala, Sweden, SE-75185
Contact: Goran FE Laurell, Professor    +46 186115363    goran.laurell@surgsci.uu.se   
Contact: Ylva M Tiblom Ehrsson, PhD, RN    +46 707747712    ylva.tiblom.ehrsson@surgsci.uu.se   
Principal Investigator: Goran FE Laurell, Professor         
Sponsors and Collaborators
Uppsala University
Swedish Cancer Society
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
Investigators
Layout table for investigator information
Principal Investigator: Goran FE Laurell, Professor Department of Otolaryngology, Head & Neck Surgery, Uppsala University Hospital
Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03343236    
Other Study ID Numbers: 160451
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
Head and neck cancer
Observational study
Three tertiary hospitals
Long-term follow-up
Survival
Immune response
Metabolomics
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Inflammation
Pathologic Processes
Neoplasms by Site
Neoplasms