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Efficacy of ONS Supplementation in HNC Outpatient Under Treatment

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ClinicalTrials.gov Identifier: NCT03688646
Recruitment Status : Unknown
Verified September 2018 by Norshariza Jamhuri, National Cancer Institute, Malaysia.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Norshariza Jamhuri, National Cancer Institute, Malaysia

Study Description
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Brief Summary:
A RCT study to compare the efficacy of ONS supplementation with standard dietary advice on nutritional outcome inHNC outpatients undergoing treatment in radiotherapy clinic. IThe study population are all adult HNC outpatients receiving radiotherapy with or without chemotherapy treatments at Radiotherapy Clinic,NCI. Selected patient will be randomized into Control Group and Intervention Group until each group have 20 subjects, where the total of sample will be 40 patients (in consideration of 50% dropouts) and data will be collected at baseline (prior to treatment), week 2, 4, and the final data will be at week 6 or final day of cancer treatment. Study objectives are to determine the efficacy of ONS supplementation in outpatient HNC undergoing treatment in Radiotherapy Clinic, NCI, to determine nutritional outcome (weight loss and BMI, body composition, dietary intake, albumin and hemoglobin level), functional outcome (handgrip strength) and side effect outcome (nutrition impact symptoms) in HNC outpatients given intensive nutrition intervention with outpatients given routine care. This study also want to find association of Intensive nutrition intervention versus routine care in nutrition outcome, functional and side effect outcome in both group. Subjects in intervention group will received standardize ONS supplementation every day during treatments once daily with frequent dietary advice accordingly to the patients condition while control group will received standard routine care which includes frequent dietary advice without supplementation of ONS. Study hypothesis is there is no significant difference in nutritional outcome, functional outcome and side effect outcome between HNC outpatients receiving INI when compared to HNC outpatient receiving routine care undergoing radiotherapy treatment. There is also no association between these two groups in nutritional outcome, functional outcome and side effect outcome.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Dietary Supplement: Intensive Nutrition Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Randomised Control Trial Study To Compare The Efficacy of ONS Supplementation With Standard Dietary Advice On Nutritional Outcome in HNC Outpatients Undergoing Treatment in Radiotherapy Clinic
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Intensive nutrition intervention group receiving standardised oral nutrition supplement provided once daily throughout cancer treatment with 4 session of dietary consultation by designated dietitian for monitoring of diet intake and diet modification to meet patient's requirement
 Dietary Supplement: Intensive Nutrition Intervention
No Intervention: Control group
Routine care were given to this group inclusive of 4 session of dietary consultation by designated dietitian for monitoring of diet intake and diet modification to meet patient's requirement and also prescription of oral nutrition supplement where needed. Oral nutrition supplement was not provided


Outcome Measures
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Primary Outcome Measures :
  1. nutritional outcome (weight changes) [ Time Frame: 7 weeks ]
    changes of outcome within and between group weight in kilogram measurement are taken during baseline, 2nd weeks, 4th weeks and 6th weeks of treatment

  2. functional outcome [ Time Frame: 7 weeks ]
    preliminary handgrip strength and changes handgrip strength in kilogram force instrument: handgrip dynamometer measurement taken during baseline, 2nd week, 4th weeks and 6th weeks of treatment instrument: body composition analyzer changes of outcome within and between group

  3. side effect outcome [ Time Frame: 7 weeks ]
    changes of nutrition impact symptoms experienced by patients within and between group instrument: validated HSNC© checklist measured during baseline, 2nd weeks, 4th weeks, and 6th weeks of treatment

  4. nutritional outcome (body composition) [ Time Frame: 7 weeks ]
    muscle mass in kilogram body fat mass in kilogram measurement taken during baseline, 2nd week, 4th weeks and 6th weeks of treatment instrument: body composition analyzer changes of outcome within and between group

  5. nutritional outcome (biochemical data - albumin and hemoglobin level) [ Time Frame: 7 weeks ]
    albumin in g/L hemoglobin in g/dL measurement taken during baseline, 2nd week, 4th weeks and 6th weeks of treatment instrument: body composition analyzer changes of outcome within and between group

  6. nutritional outcome (body mass index) [ Time Frame: 7 weeks ]
    body mass in kilogram/meter2 measurement taken during baseline, 2nd week, 4th weeks and 6th weeks of treatment instrument: body composition analyzer changes of outcome within and between group


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Those who diagnosed with Head and Neck Cancer (HNC) and receiving radiotherapy with or without chemotherapy treatments.
  2. Able to communicate.
  3. Patient admitted to ward less than 5 days.

Exclusion Criteria:

  1. Patient on tube feeding.
  2. Patient was already on ONS before study period.
  3. Patient already started treatments (referring to chemotherapy, radiotherapy and CCRT) before study period.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688646


Sponsors and Collaborators
National Cancer Institute, Malaysia
Investigators
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Principal Investigator: Norshariza Jamhuri National Cancer Institute (NCI)
More Information
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Responsible Party: Norshariza Jamhuri, Clinical Dietitian, Principal Investigator, National Cancer Institute, Malaysia
ClinicalTrials.gov Identifier: NCT03688646    
Other Study ID Numbers: NMRR-15-2171-28670
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms