The Physiological Response to Routine Head and Neck Cancer Surgery
Recruitment status was Recruiting
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Purpose
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
| Condition |
|---|
|
Head and Neck Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Neuroendocrine, Metabolic, Inflammatory and Immune Responses to Routine Head and Neck Surgery. An Observational Pilot Study |
- The maximum increase (from baseline to day 3 post-op) in cortisol, IL1 and IL6 will be calculated together with their standard deviations. [ Designated as safety issue: No ]
- The area under the curve for insulin concentration. [ Designated as safety issue: No ]
- Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op. [ Designated as safety issue: No ]
- Description of other blood parameters related to stress response. [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
This project is in keeping with the strategy of the anaesthetic and intensive care departments to push towards greater understanding of the immune, metabolic and inflammatory changes associated with surgery and how these may be modified through use of different anaesthetic and intensive care techniques. Through increased understanding of the stress, inflammatory and immune responses to surgery we may be able to modulate peri-operative care to reduce cytotoxic(Natural Killer and Cytotoxic T cell) immunosuppression and hence micrometastatic spread at the time of surgery in future studies.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with a diagnosis of cancer involving the head and neck region of the body.
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.
Contacts and Locations| Contact: Dr Craig Carr | 02078118059 | craig.carr@rmh.nhs.uk |
| United Kingdom | |
| The Royal Marsden NHS Foundation Trust | Recruiting |
| Sutton, Surrey, United Kingdom, SM25PT | |
| Principal Investigator: | Dr Craig Carr | The Royal Marsden NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Dr Craig Carr, Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01032096 History of Changes |
| Other Study ID Numbers: | CCR3168 |
| Study First Received: | December 14, 2009 |
| Last Updated: | December 14, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013