Head and Neck CancerNCT05226065
The Relationship Between Intake of Macro and Micronutrients With Clinical Outcomes of Head and Neck Cancer Patients
An observational study of Head and Neck Cancer, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Cancer is a disease caused by uncontrolled cells growth, and its incidence is increasing worldwide. One of the most common cancer is head and neck cancer (HNC), which has low survival rate. Malnutrition occurrence in HNC lower immune system and as result, decreased survival rate was found. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 112 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2021to 31 Dec 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Head and neck cancer adult patients who haven't undergone radiotherapy or chemotherapy, during radiotherapy, and after radiotherapy whose came to radiotherapy unit in Dr. Cipto Mangunkusumo Hospital, Jakarta during January 2021 to October 2021.
Who may be able to join
- head and neck cancer patients who haven't undergone radiotherapy or chemotherapy, during radiotherapy, and after radiotherapy
Who cannot join
- have contraindications for body composition measuring
- are immunodeficient or have autoimmune disease
- during immunosuppressant drugs treatment
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: The Relationship Between Intake of Macro and Micronutrients With Clinical Outcomes of Head and Neck Cancer Patients at the Radiotherapy Unit of Dr. Cipto Mangunkusumo Hospital
Cancer is a disease caused by uncontrolled cells growth, and its incidence is increasing worldwide. One of the most common cancer is head and neck cancer (HNC), which has low survival rate. Malnutrition occurrence in HNC lower immune system and as result, decreased survival rate was found. Risk factors including tumor histopathology, nutritional status, immune system, and environment have various effects on life expectancy.
Head and neck cancer treatments such as radiotherapy, chemotherapy, and surgery are not without complications. Xerostomia, stomatitis, anorexia, nausea and vomiting, dysgeusia, ageusia, also pain are commonly found during the HNC treatment procedure, and takes part in further undernutrition findings in HNC patients.
Read more
Adequate nutrition management has favorable impact in managing HNC patients' malnutrition related problems. Not only energy intake, but also macronutrients and micronutrients intake have been proved be beneficial in the outcomes of HNC patients. Branched-chain amino acids (BCAA) and zinc are namely two nutrients that have been hypothesized to be beneficent. Branched-chain amino acids are found to increase muscle mass, amino acid pools, and immune system, which resulted in preventing malnutrition and cachexia, also increasing total lymphocyte count in cancer patients. Zinc plays role in immune system, antioxidant process, and taste bud functions. Zinc supplementation is correlated to give a better outcome in taste perception and stomatitis in HNC patients who undergo radiotherapy.
This study aims to finds the correlation between BCAA intake with muscle mass and lymphocyte count in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with gustatory in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with stomatitis in HNC patients who is having radiotherapy treatment, and energy and protein intake with body weight in HNC patients after underwent radiotherapy.
- Conditions
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
body weight in kilogram
Measured: after radiotherapy (1 day)
total lymphocyte count
TLC in 1000/mcL
Measured: before radiotherapy (1 day)
taste bud perception
Henkin test
Measured: before radiotherapy (1 day)
stomatitis
stomatitis grade using WHO criteria
Measured: during radiotherapy (1 day)
muscle mass
body composition analyzer, result in kg.
Measured: before radiotherapy (1 day)
Secondary outcomes (5)
protein intake
protein intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey
Measured: during the first meeting (1 day)
energy intake
energy intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey
Measured: during the first meeting (1 day)
BCAA intake
BCAA intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey
Measured: during the first meeting (1 day)
zinc intake
zinc intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey
Measured: during the first meeting (1 day)
hair zinc level
zinc level in hair
Measured: during the first meeting if the patients undergo radiotherapy (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jan 2021
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Yohannessa Wulandari, M.Gizi, Sp GK, Universitas Indonesia
- Investigators
- Yohannessa Wulandari, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226065
- Sponsor's protocol ID
- 20-08-0928
- Status last verified
- Dec 2023
- First submitted
- 6 Jan 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kristian YY, Cahyanur R, Wulandari Y, Sinaga W, Lukito W, Prasetyawaty F, Lestari W. Correlation between branched-chain amino acids intake and total lymphocyte count in head and neck cancer patients: a cross-sectional study. BMC Nutr. 2023 Jul 14;9(1):86. doi: 10.1186/s40795-023-00746-5.
PubMed 37452428
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Intake of Macro and Micronutrients With Clinical Outcomes of Head and Neck Cancer Patients at the Radiotherapy Unit of Dr. Cipto Mangunkusumo Hospital
- ClinicalTrials.gov ID
- NCT05226065
- Acronym / sponsor ID
- 20-08-0928
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Feb 2022 (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.
Cancer is a disease caused by uncontrolled cells growth, and its incidence is increasing worldwide. One of the most common cancer is head and neck cancer (HNC), which has low survival rate. Malnutrition occurrence in HNC lower immune system and as result, decreased survival rate was found. Risk factors including tumor histopathology, nutritional status, immune system, and environment have various effects on life expectancy.
Head and neck cancer treatments such as radiotherapy, chemotherapy, and surgery are not without complications. Xerostomia, stomatitis, anorexia, nausea and vomiting, dysgeusia, ageusia, also pain are commonly found during the HNC treatment procedure, and takes part in further undernutrition findings in HNC patients.
Adequate nutrition management has favorable impact in managing HNC patients' malnutrition related problems. Not only energy intake, but also macronutrients and micronutrients intake have been proved be beneficial in the outcomes of HNC patients. Branched-chain amino acids (BCAA) and zinc are namely two nutrients that have been hypothesized to be beneficent. Branched-chain amino acids are found to increase muscle mass, amino acid pools, and immune system, which resulted in preventing malnutrition and cachexia, also increasing total lymphocyte count in cancer patients. Zinc plays role in immune system, antioxidant process, and taste bud functions. Zinc supplementation is correlated to give a better outcome in taste perception and stomatitis in HNC patients who undergo radiotherapy.
This study aims to finds the correlation between BCAA intake with muscle mass and lymphocyte count in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with gustatory in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with stomatitis in HNC patients who is having radiotherapy treatment, and energy and protein intake with body weight in HNC patients after underwent radiotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Head and neck cancer adult patients who haven't undergone radiotherapy or chemotherapy, during radiotherapy, and after radiotherapy whose came to radiotherapy unit in Dr. Cipto Mangunkusumo Hospital, Jakarta during January 2021 to October 2021.
Key inclusion criteria (1 listed)
- head and neck cancer patients who haven't undergone radiotherapy or chemotherapy, during radiotherapy, and after radiotherapy
Key exclusion criteria (3 listed)
- have contraindications for body composition measuring
- are immunodeficient or have autoimmune disease
- during immunosuppressant drugs treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
body weight
Time frame: after radiotherapy (1 day)
body weight in kilogram
total lymphocyte count
Time frame: before radiotherapy (1 day)
TLC in 1000/mcL
taste bud perception
Time frame: before radiotherapy (1 day)
Henkin test
stomatitis
Time frame: during radiotherapy (1 day)
stomatitis grade using WHO criteria
muscle mass
Time frame: before radiotherapy (1 day)
body composition analyzer, result in kg.
5 secondary outcomes
protein intake
Time frame: during the first meeting (1 day)
energy intake
Time frame: during the first meeting (1 day)
BCAA intake
Time frame: during the first meeting (1 day)
zinc intake
Time frame: during the first meeting (1 day)
hair zinc level
Time frame: during the first meeting if the patients undergo radiotherapy (1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 37452428Kristian YY, Cahyanur R, Wulandari Y, Sinaga W, Lukito W, Prasetyawaty F, Lestari W. Correlation between branched-chain amino acids intake and total lymphocyte count in head and neck cancer patients: a cross-sectional study. BMC Nutr. 2023 Jul 14;9(1):86. doi: 10.1186/s40795-023-00746-5.
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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.
Yohannessa Wulandari, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Universitas Indonesia at 1 site in Indonesia.
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 1 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: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
body weight (time frame: after radiotherapy (1 day)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05226065, which also lists 1 linked publication.
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 6 Dec 2023.