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The Physiological Response to Routine Head and Neck Cancer Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01032096
First received: December 14, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Detailed Description:

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
Study Population

Patients with a diagnosis of cancer involving the head and neck region of the body.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032096

Contacts
Contact: Dr Craig Carr 02078118059 craig.carr@rmh.nhs.uk

Locations
United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM25PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014