NCT01032096

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

3.4 years

First QC Date

December 14, 2009

Last Update Submit

May 20, 2016

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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)

  • The area under the curve for insulin concentration.

  • Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op.

  • Description of other blood parameters related to stress response.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM25PT, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Dr Craig Carr

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2009

First Posted

December 15, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

May 23, 2016

Record last verified: 2016-05

Locations

GB(1)