Clinical trial · Observational
The Physiological Response to Routine Head and Neck Cancer Surgery
The Neuroendocrine, Metabolic, Inflammatory and Immune Responses to Routine Head and Neck Surgery. An Observational Pilot Study
NCT01032096CI-TRIAL-00022341completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this pilot study is to observe and document the range of changes in the blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in response to the stimulus of Head and Neck cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The maximum increase (from baseline to day 3 post-op) in cortisol, IL1 and IL6 will be calculated together with their standard deviations.
Secondary outcomes (3)
- measure
- The area under the curve for insulin concentration.
- measure
- Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op.
- measure
- Description of other blood parameters related to stress response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Elective unilateral neck dissections (Levels I-V) and/or Hemithyroidectomy surgery. * Royal Marsden Hospital patients with head and neck cancer - all histological sub-types. * Capable of providing informed consent * Age \>17 * American Society of Anaesthesiologists Classification I-III. Exclusion Criteria: * Past history of ipsilateral neck dissection. * Bilateral neck dissection * A recent course of systemic steroids (\< 3 months) * Pregnancy * Involvement in drug trials * On following medications: Interleukins, Interferons, Immunosuppressants and long term opiates * Recent Synacthen Test (within 48 hours) * Emergency surgery * American Society of Anaesthesiologists Classification IV-V.
References
Publications (0)
Data not yet available
No reference posted for this study.