Head and Neck CancerMELINOENCT05126095
Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy
An observational study of Head and Neck Cancer and Radiotherapy; Adverse Effect, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Chemoradiotherapy is the standard treatment for unresectable locally advanced head and neck cancer (HNC). However, malnutrition is present in 44-88% HNC patients during chemoradiotherapy, which leads to loss of skeletal muscle mass (SMM) and poor clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Radiotherapy; Adverse Effect
- What is being tested?
- Radical radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2021to 30 Mar 2023
- 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: Patients with locally advanced HNC scheduled to receive radical radiotherapy
Who may be able to join
- Histologically confirmed HNC including Oral Cavity, Oropharyngeal, Nasopharynx, Hypopharyngeal, and Laryngeal Cancers
- Clinical stage II-IVa according to the American Joint Committee of Cancer (the seventh edition)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Who cannot join
- Previous head and neck radiotherapy
- Previous cervical lymph node dissection
- Active infections
- Palliative treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
YI PAN
Guangzhou, Guangdong, 510080
YI PAN, panyiff01@163.com
About this study
Official title: Monitoring Skeletal Muscle Mass Using Cone-Beam Computed Tomography in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy: Single-center Prospective Study
Chemoradiotherapy is the standard treatment for unresectable locally advanced head and neck cancer (HNC). However, malnutrition is present in 44-88% HNC patients during chemoradiotherapy, which leads to loss of skeletal muscle mass (SMM) and poor clinical outcomes. Timely assessment of SMM and early intervention of malnutrition are particularly important for HNC patients undergoing radiotherapy. However, body composition and skeletal muscle loss are not accurately reflected by the current assessment tools of malnutrition, which only measure body mass index and body weight loss.
Cone-beam CT (CBCT), a variation of traditional CT, is widely performed to ensure the appropriate position of the patients during radiotherapy. The previous study showed that measuring skeletal muscle areas and its changes using CBCT during radiotherapy is feasible. The hypothesis of this study is loss of SMM is associated with severe adverse effects in HNC patients during radiotherapy compared with body weight loss.
Read the detailed description
This is a prospective observational phase II study. Patients with locally advanced HNC scheduled to receive radical radiotherapy are prospectively enrolled in this study. CBCT and body weight are obtained before radiotherapy and once a week during radiotherapy. Severe adverse effects including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission are recorded during radiotherapy.
- Conditions
- Head and Neck Cancer, Radiotherapy; Adverse Effect
- Being tested
- Radical radiotherapy
- Keywords
- Cone-beam Computerized tomography, Skeletal Muscle Mass, Body weight, Malnutrition
- Medical subject headings
- Head and Neck Neoplasms, Radiation Injuries, Body Weight, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical radiotherapyRadiation
Intensity-modulated radiation therapy (IMRT)
| Study group | Role | What they receive |
|---|---|---|
| Trial cohort | CBCT: before radiotherapy and once a week during radiotherapy
Body weight: before radiotherapy and once a week during radiotherapy
The Patient-Generated Subjective Global Assessment (PG-SGA): before radiotherapy, 1st week, 3rd week and the last week during radiotherapy. Receives: Radiation: Radical radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The treatment-related severe adverse events
The association between Loss of SMM and treatment-related severe adverse events including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission in HNC patients during radiotherapy.
Measured: 7 weeks
Secondary outcomes (5)
The weight loss percentage
The association between percentage Loss of SMM and weight loss percetage in HNC patients during radiotherapy
Measured: 7 weeks
Scored Patient-Generated Subjective Global Assessment (PG-SGA)
The association between Loss of SMM and PG-SGA in HNC patients during radiotherapy. The PG-SGA scores typically range from 0-35, with a higher score reflecting a greater risk of malnutrition.
Measured: 7 weeks
the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy
Measured: 7 weeks
the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Cancer Module (EORTC QLQ-H&N35)
The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy
Measured: 7 weeks
Duration ofParenteral nutrition
The association between Loss of SMM and duration of parenteral nutrition in HNC patients during radiotherapy
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 posted18 Nov 2021
- Study start3 Nov 2021
- Primary completion14 Jun 2022 (estimated)
- Study completion30 Mar 2023 (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.
- More trials run by Guangdong Provincial People's HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YI PAN, Guangdong Provincial People's Hospital
- Investigators
- YI PAN, Prof., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126095
- Sponsor's protocol ID
- KY-Q-2021-213
- Acronym
- MELINOE
- Status last verified
- Nov 2021
- First submitted
- 7 Nov 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Skeletal Muscle Mass Using Cone-Beam Computed Tomography in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy: Single-center Prospective Study
- ClinicalTrials.gov ID
- NCT05126095
- Acronym / sponsor ID
- MELINOE / KY-Q-2021-213
- Conditions
- Head and Neck Cancer, Radiotherapy; Adverse Effect
- Keywords
- Cone-beam Computerized tomography, Skeletal Muscle Mass, Body weight, Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 14 Jun 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 18 Nov 2021 (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.
Chemoradiotherapy is the standard treatment for unresectable locally advanced head and neck cancer (HNC). However, malnutrition is present in 44-88% HNC patients during chemoradiotherapy, which leads to loss of skeletal muscle mass (SMM) and poor clinical outcomes. Timely assessment of SMM and early intervention of malnutrition are particularly important for HNC patients undergoing radiotherapy. However, body composition and skeletal muscle loss are not accurately reflected by the current assessment tools of malnutrition, which only measure body mass index and body weight loss.
Cone-beam CT (CBCT), a variation of traditional CT, is widely performed to ensure the appropriate position of the patients during radiotherapy. The previous study showed that measuring skeletal muscle areas and its changes using CBCT during radiotherapy is feasible. The hypothesis of this study is loss of SMM is associated with severe adverse effects in HNC patients during radiotherapy compared with body weight loss.
Detailed description
This is a prospective observational phase II study. Patients with locally advanced HNC scheduled to receive radical radiotherapy are prospectively enrolled in this study. CBCT and body weight are obtained before radiotherapy and once a week during radiotherapy. Severe adverse effects including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission are recorded during radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial cohort | – | Radiation: Radical radiotherapyCBCT: before radiotherapy and once a week during radiotherapy Body weight: before radiotherapy and once a week during radiotherapy The Patient-Generated Subjective Global Assessment (PG-SGA): before radiotherapy, 1st week, 3rd week and the last week during radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced HNC scheduled to receive radical radiotherapy
Key inclusion criteria (3 listed)
- Histologically confirmed HNC including Oral Cavity, Oropharyngeal, Nasopharynx, Hypopharyngeal, and Laryngeal Cancers
- Clinical stage II-IVa according to the American Joint Committee of Cancer (the seventh edition)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (4 listed)
- Previous head and neck radiotherapy
- Previous cervical lymph node dissection
- Active infections
- Palliative treatment
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 |
|---|---|---|
| Radical radiotherapyIntensity-modulated radiation therapy (IMRT) | Radiation | Trial cohort |
Primary outcome
The treatment-related severe adverse events
Time frame: 7 weeks
The association between Loss of SMM and treatment-related severe adverse events including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission in HNC patients during radiotherapy.
5 secondary outcomes
The weight loss percentage
Time frame: 7 weeks
Scored Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: 7 weeks
the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: 7 weeks
the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Cancer Module (EORTC QLQ-H&N35)
Time frame: 7 weeks
Duration ofParenteral nutrition
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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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.
YI PAN, Prof. principal investigator
Guangdong Provincial People's Hospital
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 and Radiotherapy; Adverse Effect, run by Guangdong Provincial People's Hospital at 1 site in China.
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 4 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 2 Dec 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Pan, Prof. (+862083827812 ext. 50150, panyiff01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The treatment-related severe adverse events (time frame: 7 weeks). 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 2 Dec 2021.