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Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy


N/A
35 Years
85 Years
Not Enrolling
Both
Head and Neck Cancer, Dysphagia

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Trial Information

Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy


- independent variable: continuous Nutri -jelly intake

- dependent variable (outcome): changes in health-related quality of life score


Inclusion Criteria:



- diagnosed as head and neck cancer

- definitive or palliative radiotherapy treatment plan

- can communicate well

Exclusion Criteria:

- bleeding in the mouth

- respiratory distress

- psychiatric disorders

- radiation field not involve masticatory and swallowing apparatus e.g. certain cases
of laryngeal cancer and brain cancer

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Changes in Health-related quality of life score

Outcome Description:

Definitive cases: collect data at baseline (0-5), after Nutri-jelly (6-10), 11-15, 16-20, 21-25, 26-30, 31-35 fractions of RT), total period of 6 weeks Palliative cases: collect data at baseline (0-5), after Nutri-jelly (6-10) fractions of RT, total period of 2 weeks

Outcome Time Frame:

0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy

Safety Issue:

No

Principal Investigator

Dunyaporn Trachootham, DDS, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Faculty of Dentistry, Thammasat University, Thailand

Authority:

Thailand: Ethical Committee

Study ID:

DIF-01

NCT ID:

NCT01871155

Start Date:

January 2012

Completion Date:

August 2012

Related Keywords:

  • Head and Neck Cancer
  • Dysphagia
  • Deglutition Disorders
  • Head and Neck Neoplasms

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