Head and Neck CancerNCT03688646
Efficacy of ONS Supplementation in HNC Outpatient Under Treatment
A study testing Intensive Nutrition Intervention in people with Head and Neck Cancer, run by National Cancer Institute, Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Intensive Nutrition Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who diagnosed with Head and Neck Cancer (HNC) and receiving radiotherapy with or without chemotherapy treatments.
- Able to communicate.
- Patient admitted to ward less than 5 days.
Who cannot join
- Patient on tube feeding.
- Patient was already on ONS before study period.
- Patient already started treatments (referring to chemotherapy, radiotherapy and CCRT) before study period.
About this study
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
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Intensive Nutrition Intervention
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Nutrition InterventionDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Dietary Supplement: Intensive Nutrition Intervention |
| Control group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional outcome (weight changes)
changes of outcome within and between group weight in kilogram measurement are taken during baseline, 2nd weeks, 4th weeks and 6th weeks of treatment
Measured: 7 weeks
functional outcome
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
Measured: 7 weeks
side effect outcome
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
Measured: 7 weeks
nutritional outcome (body composition)
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
Measured: 7 weeks
nutritional outcome (biochemical data - albumin and hemoglobin level)
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
Measured: 7 weeks
nutritional outcome (body mass index)
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
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study startSep 2016
- Primary completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Norshariza Jamhuri, National Cancer Institute, Malaysia
- Investigators
- Norshariza Jamhuri, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688646
- Sponsor's protocol ID
- NMRR-15-2171-28670
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03688646
- Acronym / sponsor ID
- NMRR-15-2171-28670
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute, MalaysiaOther government
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2018 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Intensive Nutrition InterventionIntensive 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 |
| Control group | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who diagnosed with Head and Neck Cancer (HNC) and receiving radiotherapy with or without chemotherapy treatments.
- Able to communicate.
- Patient admitted to ward less than 5 days.
Key exclusion criteria (3 listed)
- Patient on tube feeding.
- Patient was already on ONS before study period.
- Patient already started treatments (referring to chemotherapy, radiotherapy and CCRT) before study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Nutrition Intervention | Dietary supplement | Intervention group |
Primary outcome
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norshariza Jamhuri principal investigator
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Nutrition Intervention in people with Head and Neck Cancer, run by National Cancer Institute, Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nutritional outcome (weight changes) (time frame: 7 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.