FindTrial
Sign In

Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01871155
Enrollment
64
Registered
2013-06-06
Start date
2012-01-31
Completion date
2012-08-31
Last updated
2013-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Head and Neck Cancer

Brief summary

The purpose of this study is to determine whether a novel edible nutritious gel for patients with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality of life of head and neck cancer patients while undergoing conventional radiotherapy.

Detailed description

* independent variable: continuous Nutri -jelly intake * dependent variable (outcome): changes in health-related quality of life score

Interventions

DIETARY_SUPPLEMENTNutri-jelly

an edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal 1 serving is considered as food supplement

Sponsors

Thammasat University
CollaboratorOTHER
Srinakharinwirot University
CollaboratorOTHER
Mahidol University
CollaboratorOTHER
Ministry of Health, Thailand
CollaboratorOTHER_GOV
Dental Innovation Foundation Under Royal Patronage
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Health-related quality of life score0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy* 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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026