Esophagus CancerGENTLEMANNCT06510543
Goal-directed Enteral Nutritional Perioperative Management
A study testing Goal-directed EN therapy and Conventional EN therapy in people with Esophagus Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 17 sites in China.
Trial summary
This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Goal-directed EN therapy and Conventional EN therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 17 sitesChina
- Study dates
- 30 Mar 2024to 30 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years old;
- ECOG PS 0~1;
- NRS 2002 score ≥3;
- Malnutrition diagnosed according to the GLIM criteria;
- Histopathologically confirmed as esophageal squamous cell carcinoma;
- Primary tumors located in thoracic esophagus;
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- Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC/AJCC) evaluated by a multidisciplinary team;
- Neoadjuvant therapy will be administered, which may entail preoperative chemo-radiotherapy, chemotherapy only, or a combination of immunotherapy such as anti-PD-1/PD-L1;
- Informed consent for random assignment and completion of the protocol.
Who cannot join
- NRS 2002 score < 3;
- Upfront surgery without neoadjuvant treatment;
- Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
- Receiving any other nutritional support during the study;
- Unable to consume nutrition orally or receive it through tube feeding before surgery;
- History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
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- Severe abnormalities of liver and kidney functions (ALT≥2 times the upper limit of normal; Total bilirubin Tbil≥2 upper limit of normal; Creatinine Cr≥2 upper limit of normal);
- Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol/L, hypothyroidism, or hyperthyroidism;
- Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents
- History of known allergy to any component of ORAL IMPACT®;
- Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test at baseline or not using a reliable and appropriate contraceptive method;
- Refuse to sign the consent or unable to follow the study protocol;
- Inappropriate to participate in this study judged by investigators.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
Anyang Cancer Hospital
Anyang, Henan
Anlin Hao, M.D.
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yin Li, M.D., +86 (010) 87788052, liyin@cicams.ac.cn
- Recruiting
Changzhi People's Hospital
Changzhi, Shanxi
Changhong Lian, M.D.
- Recruiting
Daping Hospital, Third Affiliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality
Wei Guo, M.D.
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Shuoyan Liu, M.D.
- Recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu
Jianqiang Zhao, M.D.
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Lin Li, M.D.
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Lin Zhang, M.D.
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
Guangqiang Zhao, M.D.
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Feng Jiang, M.D.
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Jinhua Luo, M.D.
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Zhigang Li, M.D.
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Lijie Tan, M.D.
- Recruiting
Shanxi Cancer Hospital, Chinese Academy of Medical Sciences
Taiyuan, Shanxi
Jianhong Lian, M.D.
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Peng Tang, M.D.
- Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Xiangnan Li, M.D.
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Yan Zheng, M.D.
About this study
Official title: Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management
This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis. Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival.
Read the detailed description
Severe malnutrition is a significant risk factor for postoperative complications in esophageal cancer patients. Early oral nutritional supplementation after surgery can prevent weight loss and improve quality of life. The EFFORT trial showed that individual-based enteral nutrition support reduced complications, extended 1-year survival, and improved quality of life. This study aims to assess the safety and effectiveness of individualized perioperative nutrition support guided by daily energy targets in esophageal cancer patients at nutritional risk. It also seeks to determine if supplementing immunonutrition can effectively reduce postoperative complications. This study was conducted as a multicenter, open-label, randomized, controlled phase 3 trial. The experiment group was administered goal-directed enteral nutritional therapy, while the control group received conventional enteral nutritional therapy. The study observed the participants' major pulmonary and other complications within 90 days post-surgery and nutritional status, disease-free survival (DFS), and overall survival (OS) in both groups.
- Conditions
- Esophagus Cancer
- Being tested
- Goal-directed EN therapy, Conventional EN therapy
- Keywords
- Esophageal Cancer, Esophagectomy, Nutritional Therapy, Morbidity, Survival, Malnourished
- Medical subject headings
- Esophageal Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed EN therapyDietary supplement
The participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal.
Conventional EN therapyDietary supplement
The participants will be administered the conventional nutritional therapy according to the Chinese expert consensus on perioperative nutritional support in enhanced recovery after surgery (2019 edition).
| Study group | Role | What they receive |
|---|---|---|
| Goal-directed enteral nutritional therapy | Experimental | The participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal. Receives: Dietary Supplement: Goal-directed EN therapy |
| Conventional enteral nutritional therapy | Active comparator | The participants will be administered with an unsupervised and liberal nutritional support. The EN regimens will not include ORAL IMPACT®. Receives: Dietary Supplement: Conventional EN therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative pulmonary complications
According to the Esophagectomy Complications Consensus Group (ECCG) standardization of complications reporting, pulmonary complications include pneumonia, pleural effusion, pneumothorax, atelectasis, mucous plugging, respiratory failure, acute respiratory distress syndrome, acute aspiration, tracheobronchial injury, and prolonged air-leak.
Measured: Randomization to three months after surgery
Rate of unplanned hospital admissions
Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute hospital admission.
Measured: Randomization to three months after surgery
Rate of unplanned ICU admission
Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute ICU admission.
Measured: Randomization to three months after surgery
Overall survival
The time from randomization to death. Any patients lost to follow up or still alive at the time of evaluation are censored.
Measured: Randomization to five years
Secondary outcomes (9)
Rate of postoperative non-pulmonary complications
Non-pulmonary complications according to the ECCG standardization of complications reporting.
Measured: Randomization to three months after surgery
Level of serum prealbumin
Prealbumin, also known as transthyretin, has a half-life in plasma of ∼2 days, much shorter than that of albumin. Prealbumin is therefore more sensitive to changes in protein-energy status than albumin, and its concentration closely reflects recent dietary intake rather than overall nutritional status.
Measured: Randomization to three months after surgery
Body mass index (BMI)
A person's weight in kilograms divided by the square of height in meters.
Measured: Randomization to three months after surgery
Lean body mass
The weight of the body minus the fat content, representing the amount of muscle, bone, and organs in the body.
Measured: Randomization to three months after surgery
Rate of treatment-related adverse events (TRAEs)
An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
Measured: Randomization to three months after surgery
Rate of R0 resection
Distance between tumor and the circumferential resection margin (CRM) more than 1 mm.
Measured: Randomization to three months after surgery
Rate of pathologic complete response (pCR)
The absence of invasive/in situ cancer in the resected esophagus and regional lymph nodes.
Measured: Randomization to three months after surgery
Disease-free survival (DFS)
Defined as the proportion of patients without disease progression or death.
Measured: Randomization to five years
Scale of health-related quality of life (HRQOL)
A state of complete physical, mental and social well-being, and not merely the absence of disease and infirmity evaluated by EORTC OES18、EQ-5D、FAACT.
Measured: Randomization to three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start30 Mar 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YIN LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Yin Li, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510543
- Sponsor's protocol ID
- GENTLEMAN
- Acronym
- GENTLEMAN
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management
- ClinicalTrials.gov ID
- NCT06510543
- Acronym / sponsor ID
- GENTLEMAN / GENTLEMAN
- Conditions
- Esophagus Cancer
- Keywords
- Esophageal Cancer, Esophagectomy, Nutritional Therapy, Morbidity, Survival, Malnourished
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 May 2031 (estimated)
- First posted
- 19 Jul 2024 (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.
This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis. Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival.
Detailed description
Severe malnutrition is a significant risk factor for postoperative complications in esophageal cancer patients. Early oral nutritional supplementation after surgery can prevent weight loss and improve quality of life. The EFFORT trial showed that individual-based enteral nutrition support reduced complications, extended 1-year survival, and improved quality of life. This study aims to assess the safety and effectiveness of individualized perioperative nutrition support guided by daily energy targets in esophageal cancer patients at nutritional risk. It also seeks to determine if supplementing immunonutrition can effectively reduce postoperative complications. This study was conducted as a multicenter, open-label, randomized, controlled phase 3 trial. The experiment group was administered goal-directed enteral nutritional therapy, while the control group received conventional enteral nutritional therapy. The study observed the participants' major pulmonary and other complications within 90 days post-surgery and nutritional status, disease-free survival (DFS), and overall survival (OS) in both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-directed enteral nutritional therapy | Experimental | Dietary Supplement: Goal-directed EN therapyThe participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal. |
| Conventional enteral nutritional therapy | Active comparator | Dietary Supplement: Conventional EN therapyThe participants will be administered with an unsupervised and liberal nutritional support. The EN regimens will not include ORAL IMPACT®. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18-80 years old;
- ECOG PS 0~1;
- NRS 2002 score ≥3;
- Malnutrition diagnosed according to the GLIM criteria;
- Histopathologically confirmed as esophageal squamous cell carcinoma;
Key exclusion criteria (13 listed)
- NRS 2002 score < 3;
- Upfront surgery without neoadjuvant treatment;
- Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
- Receiving any other nutritional support during the study;
- Unable to consume nutrition orally or receive it through tube feeding before surgery;
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 |
|---|---|---|
| Goal-directed EN therapyThe participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal. | Dietary supplement | Goal-directed enteral nutritional therapy |
| Conventional EN therapyThe participants will be administered the conventional nutritional therapy according to the Chinese expert consensus on perioperative nutritional support in enhanced recovery after surgery (2019 edition). | Dietary supplement | Conventional enteral nutritional therapy |
Primary outcome
Rate of postoperative pulmonary complications
Time frame: Randomization to three months after surgery
According to the Esophagectomy Complications Consensus Group (ECCG) standardization of complications reporting, pulmonary complications include pneumonia, pleural effusion, pneumothorax, atelectasis, mucous plugging, respiratory failure, acute respiratory distress syndrome, acute aspiration, tracheobronchial injury, and prolonged air-leak.
Rate of unplanned hospital admissions
Time frame: Randomization to three months after surgery
Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute hospital admission.
Rate of unplanned ICU admission
Time frame: Randomization to three months after surgery
Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute ICU admission.
Overall survival
Time frame: Randomization to five years
The time from randomization to death. Any patients lost to follow up or still alive at the time of evaluation are censored.
9 secondary outcomes
Rate of postoperative non-pulmonary complications
Time frame: Randomization to three months after surgery
Level of serum prealbumin
Time frame: Randomization to three months after surgery
Body mass index (BMI)
Time frame: Randomization to three months after surgery
Lean body mass
Time frame: Randomization to three months after surgery
Rate of treatment-related adverse events (TRAEs)
Time frame: Randomization to three months after surgery
Rate of R0 resection
Time frame: Randomization to three months after surgery
Rate of pathologic complete response (pCR)
Time frame: Randomization to three months after surgery
Disease-free survival (DFS)
Time frame: Randomization to five years
Scale of health-related quality of life (HRQOL)
Time frame: Randomization to three months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- 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.
Yin Li, M.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-directed EN therapy and Conventional EN therapy in people with Esophagus Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 17 sites 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaozheng Kang, M.D. (+86 13910052790, kangxz@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative pulmonary complications (time frame: Randomization to three months after surgery). The study lists 4 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 19 Jul 2024.