Nasopharyngeal CarcinomaPhase 2NCT02776124
Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients
A Phase 2 study testing Healing Elements,Methuselah Medical Technology in people with Nasopharyngeal Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Healing Elements,Methuselah Medical Technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jan 2018
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed、pathologically proven nasopharyngeal carcinoma（Stage III/IV）
- Concurrent radiation and chemotherapy(platinum )
- Karnofsky score over 60
- No evidence of metastatic disease
- No significant cardiac, chest, gastrointestinal or renal morbidities
Who cannot join
- age <18 years
- ongoing artificial nutrition
- refusal
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, 200011
About this study
Official title: A Randomized Phase II Trial to Assess the Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients During Concurrent Chemotherapy
Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems. Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality. Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear. Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Healing Elements,Methuselah Medical Technology
- Keywords
- Nutritional status, nasopharyngeal carcinoma, Nutritional Counseling, concurrent chemoradiotherapy, oral nutritional supplements
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing Elements,Methuselah Medical TechnologyDietary supplement
ONS group will receive Healing Elements ONS everyday during CRT
| Study group | Role | What they receive |
|---|---|---|
| ONS group | Experimental | Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements) Receives: Dietary Supplement: Healing Elements,Methuselah Medical Technology |
| control group | No intervention | Individualized dietary counseling during CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight(kg)change during concurrent chemotherapy
Measured: every week during the course of radiotherapy, up to 6-7 weeks
Secondary outcomes (11)
Disease-free survival
From date of randomization until date of first documented disease progression or death from any cause, assessed up to 2 years.
Measured: 2 years
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
participants will be followed for the duration of hospital stay, an expected average of 6-7 weeks
Measured: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Measured: every week during the course of radiotherapy, up to 6-7 weeks
Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis
Measured: every week during the course of radiotherapy, up to 6-7 weeks
Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Measured: every week during the course of radiotherapy, up to 6-7 weeks
Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Measured: every week during the course of radiotherapy, up to 6-7 weeks
Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Measured: every week during the course of radiotherapy, up to 6-7 weeks
Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis
Measured: every week during the course of radiotherapy, up to 6-7 weeks
Serum albumin（g/L) change
Measured: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Serum prealbumin（mg/dL) change
Measured: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Serum transferrins（mg/dL）change
Measured: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJun 2014
- Primary completionAug 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Principal investigator, Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776124
- Sponsor's protocol ID
- 1405135-4
- Status last verified
- Mar 2018
- First submitted
- 3 May 2016
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial to Assess the Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients During Concurrent Chemotherapy
- ClinicalTrials.gov ID
- NCT02776124
- Acronym / sponsor ID
- 1405135-4
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nutritional status, nasopharyngeal carcinoma, Nutritional Counseling, concurrent chemoradiotherapy, oral nutritional supplements
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Jun 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 18 May 2016 (estimated)
- 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.
Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems. Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality. Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear. Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONS group | Experimental | Dietary Supplement: Healing Elements,Methuselah Medical TechnologyIndividualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements) |
| control group | No intervention | –Individualized dietary counseling during CRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed、pathologically proven nasopharyngeal carcinoma（Stage III/IV）
- Concurrent radiation and chemotherapy(platinum )
- Karnofsky score over 60
- No evidence of metastatic disease
- No significant cardiac, chest, gastrointestinal or renal morbidities
Key exclusion criteria (3 listed)
- age <18 years
- ongoing artificial nutrition
- refusal
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 |
|---|---|---|
| Healing Elements,Methuselah Medical TechnologyONS group will receive Healing Elements ONS everyday during CRT | Dietary supplement | ONS group |
Primary outcome
Body weight(kg)change during concurrent chemotherapy
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
11 secondary outcomes
Disease-free survival
Time frame: 2 years
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Serum albumin（g/L) change
Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Serum prealbumin（mg/dL) change
Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Serum transferrins（mg/dL）change
Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
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 19 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Healing Elements,Methuselah Medical Technology in people with Nasopharyngeal Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 5 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 19 Mar 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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(kg)change during concurrent chemotherapy (time frame: every week during the course of radiotherapy, up to 6-7 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 19 Mar 2018.