NCT00995319

Brief Summary

The purpose of this clinical investigation is to evaluate acute and longlasting side effects in patients undergoing radiotherapy for cancer treatment in the head and neck area.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 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

January 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

October 14, 2009

Last Update Submit

March 31, 2017

Conditions

Head and Neck Cancer

Keywords

mouthMucositisDysphagiamalnutritionXerostomiasalivatooth injuries

Outcome Measures

Primary Outcomes (2)

  • salivary flow

    3 months

  • salivary flow

    12 months

Study Arms (1)

radiation patients

cancer patients with radiotherapy concerning the head and neck area/oral cavity

Eligibility Criteria

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

All cancer patients with radiation therapy concerning the oral cavity who are in care of the Detal Team at St.Olavs University Hospital

You may qualify if:

  • radiation concerning the oral cavity
  • follow-up at the Dental Team

You may not qualify if:

  • refused approval
  • survival prognosis under one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Oral and Maxillofacial Surgery, St.Olavs Hospital / NTNU

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMucositisDeglutition DisordersMalnutritionXerostomiaTooth Injuries

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic DiseasesEsophageal DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSalivary Gland DiseasesTooth DiseasesWounds and Injuries

Study Officials

  • Christoph M Ziegler, Prof.Dr.Dr.

    St.Olavs Hospital / NTNU

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2013

Study Completion

July 1, 2014

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

NO(1)