Esophageal CancerNCT03286920
Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer
An observational study of Esophageal Cancer, run by Peking University Cancer Hospital & Institute at 23 sites in China.
Trial summary
This clinical trial is designed to be a multi-center prospective observational study which shall compare the effect of different postoperative home nutrition modes on recent nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Oral nutrition supplement and Tube feeding nutrition supplement
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 23 sitesChina
- Study dates
- 20 Sep 2017to Sep 2018
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with esophageal cancer who undergo surgery
Who may be able to join
- Age below 80 years old;
- Esophageal cancer;
- Radical surgery;
- Normal gastrointestinal function
Who cannot join
- Patients with diabetes and poor blood glucose control;
- Patients with severe postoperative complications;
- Patients who can't tolerate lactose;
- Patients who decline inclusion and follow-ups
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
Anyang Tumor Hospital
Anyang, Henan
Xiaotian Shi, M.D., +86 13703725817, shxt531216sh@163.com
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Keneng Chen, M.D., +86 13501085973, chenkeneng@bjmu.edu.cn
Liang Dai, M.D., +86 18610065191, dailiangsharp_26@aliyun.com
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Deruo Liu, M.D., +86 13801186957, fenghongxiang617@126.com
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Zhipeng Ren, M.D., +86 15901297308, renzhipeng04@163.com
- Recruiting
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui
Yang Geng, Master, +86 15755235970, 495922402@qq.com
- Recruiting
First Hospital of Jilin University
Changchun, Jilin
Youbin Cui, M.D., +86 13364513508, cuiyb@jlu.edu.cn
- Recruiting
Second Xiangya Hospital of Central South University
Changsha, Hunan
Wenliang Liu, M.D., +86 13507438708, liuwenliang1859@163.com
- Recruiting
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality
Wei Guo, M.D., +86 13527323568, gyguowei@hotmail.com
- Recruiting
Union hospital of Fujian Medical University
Fuzhou, Fujian
Chun Chen, M.D., +86 13365910325, chenchun0209@163.com
- Recruiting
Sun Yat-sen University Cancer Hospital
Guangdong, Guangdong
Wenfeng Ye, M.D., +86 13902266462, gzyewf@hotmai.com
- Recruiting
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong
Guibin Qiao, M.D., +86 13602749153, guibinqiao@126.com
- Recruiting
Zhejiang Cancer Hospital
Hanzhou, Zhejiang
Qixun Chen, M.D>, +86 13958108371, chenqixun64@sina.com
- Recruiting
The Third Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Jianqun Ma, M.D., +86 13359990466, jianqunma@aliyun.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Zaicheng Yu, Master, +86 13705699600, 13705699600@163.com
Renquan Zhang, Master, +86 13505693475, zhangrenquan@live.cn
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Hui Tian, M.D., +86 13791122838, tianhuiql@126.com
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Zhou Wang, M.D., +86 13665312567, wz620226@hotmail.com
- Recruiting
First People's Hospital of Yunan province
Kunming, Yunan
Liang Bu, M.D., +86 13611000133, thoracicsurgeon@vip.sina.com
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality
Hong Hu, Master, +86 13512102066, huhong0997@163.com
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Zhigang Li, M.D., +86 13816121518, dr_lizhigang@hotmail.com
- Recruiting
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning
Hongxu Liu, M.D., +86 13840004476
- Recruiting
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei
Ming He, M.D., +86 13833187902, heming6699@sina.com
- Recruiting
Shanxi Province Cancer Hospital
Taiyuan, Shanxi
Shiping Guo, Master, +86 13700541808, chunhua527@126.com
- Recruiting
Tongji Hospital
Wuhan, Hubei
Xiangning Fu, M.D., +86 13607150390, fuxn2006@aliyun.com
About this study
This clinical trial is designed to be a multi-center prospective observational study which shall compare the effect of different postoperative home nutrition modes on recent nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes. Different postoperative home nutrition modes adopted in this study includes oral natural diet, oral nutrition supplement and tube feeding.
Read the detailed description
STUDY BACKGROUND Esophageal cancer is a common cancer in China and due to its influence on diet intake, patients with esophageal cancer are often combined with nutrition deficiency, which causes relatively high nutrition risk to treatment. Studies conducted by Martin et al showed that the degree of body weight loss in patients with malignancy is related to BMI level and prognosis. The patients with severe body weight loss and low BMI have poor prognosis, especially for patients with esophageal cancer.
At present, perioperative nutrition support for patients with esophageal cancer has been recognized and has been recommended as routine in 2017 NCCN guideline. How to implement good home nutrition within one month after patient discharge and recover nutrition index as soon as possible has become a focus for esophageal surgeon.
Many clinical trials have already investigated enteral nutrition support approach during anti-cancer treatment period in patients with malignancy. However, only a few clinical trials are good designed. Therefore the investigators hope to via this multi-center prospective observational study to provide evidence for this question.
OBJECTIVES:
- To explore the relationship between postoperative home nutrition support treatment approach and nutritional status of patients with esophageal cancer;
- To explore the relationship between postoperative home nutrition support treatment approach and recent prognosis in patients with esophageal cancer;
- To promote the standardized application of postoperative home nutrition support treatment for patients with esophageal cancer.\
OUTLINE:
Included patients shall be divided into three groups according to the treatment plan of all centers, including oral natural diet, oral nutrition supplement and tube feeding. As for patients in oral natural diet group, the patients shall receive oral natural diet. As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d. As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding enteral supplement providing 750-1500kcal/d.
All the included patients shall be followed up weekly within 1-3 weeks after discharge via telephone, at Day 30 after discharge and at Day 90 after discharge to assess the effectiveness and safety of different home nutrition supplement approaches.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
- Conditions
- Esophageal Cancer
- Being tested
- Oral nutrition supplement, Tube feeding nutrition supplement
- Keywords
- home nutrition, BMI, postoperative, body weight
- Medical subject headings
- Esophageal Neoplasms, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutrition supplementDietary supplement
As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.
Tube feeding nutrition supplementDietary supplement
As for patients in tube feeding group, in addition to oral natural die, the participants shall receive Tube feeding nutrition supplement providing 750-1500kcal/d.
| Study group | Role | What they receive |
|---|---|---|
| Oral natural diet | As for patients in oral natural diet group, the the participants shall receive oral natural diet. | |
| Oral nutrition supplement group | As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d. Receives: Dietary Supplement: Oral nutrition supplement | |
| Tube feeding nutrition supplement group | As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding nutrition supplement providing 750-1500kcal/d. Receives: Dietary Supplement: Tube feeding nutrition supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of 5% body weight loss on Day 30
Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge
Measured: Day 30 after discharge
Secondary outcomes (5)
Completion ratio of different nutrition support approaches
Completion ratio of different nutrition support approaches
Measured: Day 30 after discharge
Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale
Assessment on patients' quality of life using EORTC QLQ-C30 scale and QLQ-OG25 scale in different nutrition support approach groups and investigate the relationship between different nutrition support approaches and patients' quality of life
Measured: Day30 and Day 90
Complications of home enteral nutrition support
Assessment on complications of home enteral nutrition support
Measured: Day30
Delay and interruption ratio of adjuvant treatment
Delay and interruption ratio of adjuvant treatment including whether chemotherapy and radiotherapy can be implemented on time
Measured: Day 30 and Day 90
Re-hospitalization ratio
Re-hospitalization ratio within 90 days after discharge
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start20 Sep 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Zhejiang Cancer Hospital, Shanghai Chest Hospital, China-Japan Friendship Hospital, Fudan University, Shandong Provincial Hospital, Hebei Medical University Fourth Hospital, Anyang Tumor Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University, Tongji Hospital, Shanxi Province Cancer Hospital, The Third Affiliated Hospital of Harbin Medical University, Liaoning Cancer Hospital & Institute, Wuhan General Hospital of Guangzhou Military Command, Second Xiangya Hospital of Central South University, The First Hospital of Jilin University, Chinese PLA General Hospital, Hunan Provincial People's Hospital, Fujian Cancer Hospital, Qilu Hospital of Shandong University, Union hospital of Fujian Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Responsible party
- Principal investigator, Ke-Neng Chen, MD, PhD, FRCS, Peking University Cancer Hospital & Institute
- Investigators
- Keneng Chen, M.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286920
- Sponsor's protocol ID
- 2017-06-01
- Status last verified
- Jan 2018
- First submitted
- 15 Sep 2017
- Last updated
- 23 Jan 2018
- 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 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03286920
- Acronym / sponsor ID
- 2017-06-01
- Conditions
- Esophageal Cancer
- Keywords
- home nutrition, BMI, postoperative, body weight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Zhejiang Cancer Hospital, Shanghai Chest Hospital, China-Japan Friendship Hospital, Fudan University, Shandong Provincial Hospital, Hebei Medical University Fourth Hospital, Anyang Tumor Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University, Tongji Hospital, Shanxi Province Cancer Hospital, The Third Affiliated Hospital of Harbin Medical University, Liaoning Cancer Hospital & Institute, Wuhan General Hospital of Guangzhou Military Command, Second Xiangya Hospital of Central South University, The First Hospital of Jilin University, Chinese PLA General Hospital, Hunan Provincial People's Hospital, Fujian Cancer Hospital, Qilu Hospital of Shandong University, Union hospital of Fujian Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Sep 2017 (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 is designed to be a multi-center prospective observational study which shall compare the effect of different postoperative home nutrition modes on recent nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes. Different postoperative home nutrition modes adopted in this study includes oral natural diet, oral nutrition supplement and tube feeding.
Detailed description
STUDY BACKGROUND Esophageal cancer is a common cancer in China and due to its influence on diet intake, patients with esophageal cancer are often combined with nutrition deficiency, which causes relatively high nutrition risk to treatment. Studies conducted by Martin et al showed that the degree of body weight loss in patients with malignancy is related to BMI level and prognosis. The patients with severe body weight loss and low BMI have poor prognosis, especially for patients with esophageal cancer.
At present, perioperative nutrition support for patients with esophageal cancer has been recognized and has been recommended as routine in 2017 NCCN guideline. How to implement good home nutrition within one month after patient discharge and recover nutrition index as soon as possible has become a focus for esophageal surgeon.
Many clinical trials have already investigated enteral nutrition support approach during anti-cancer treatment period in patients with malignancy. However, only a few clinical trials are good designed. Therefore the investigators hope to via this multi-center prospective observational study to provide evidence for this question.
OBJECTIVES:
- To explore the relationship between postoperative home nutrition support treatment approach and nutritional status of patients with esophageal cancer;
- To explore the relationship between postoperative home nutrition support treatment approach and recent prognosis in patients with esophageal cancer;
- To promote the standardized application of postoperative home nutrition support treatment for patients with esophageal cancer.\
OUTLINE:
Included patients shall be divided into three groups according to the treatment plan of all centers, including oral natural diet, oral nutrition supplement and tube feeding. As for patients in oral natural diet group, the patients shall receive oral natural diet. As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d. As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding enteral supplement providing 750-1500kcal/d.
All the included patients shall be followed up weekly within 1-3 weeks after discharge via telephone, at Day 30 after discharge and at Day 90 after discharge to assess the effectiveness and safety of different home nutrition supplement approaches.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral natural diet | – | –As for patients in oral natural diet group, the the participants shall receive oral natural diet. |
| Oral nutrition supplement group | – | Dietary Supplement: Oral nutrition supplementAs for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d. |
| Tube feeding nutrition supplement group | – | Dietary Supplement: Tube feeding nutrition supplementAs for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding nutrition supplement providing 750-1500kcal/d. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with esophageal cancer who undergo surgery
Key inclusion criteria (4 listed)
- Age below 80 years old;
- Esophageal cancer;
- Radical surgery;
- Normal gastrointestinal function
Key exclusion criteria (4 listed)
- Patients with diabetes and poor blood glucose control;
- Patients with severe postoperative complications;
- Patients who can't tolerate lactose;
- Patients who decline inclusion and follow-ups
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 |
|---|---|---|
| Oral nutrition supplementAs for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d. | Dietary supplement | Oral nutrition supplement group |
| Tube feeding nutrition supplementAs for patients in tube feeding group, in addition to oral natural die, the participants shall receive Tube feeding nutrition supplement providing 750-1500kcal/d. | Dietary supplement | Tube feeding nutrition supplement group |
Primary outcome
Percentage of 5% body weight loss on Day 30
Time frame: Day 30 after discharge
Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge
5 secondary outcomes
Completion ratio of different nutrition support approaches
Time frame: Day 30 after discharge
Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale
Time frame: Day30 and Day 90
Complications of home enteral nutrition support
Time frame: Day30
Delay and interruption ratio of adjuvant treatment
Time frame: Day 30 and Day 90
Re-hospitalization ratio
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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.
Keneng Chen, M.D. principal investigator
Peking University Cancer Hospital & Institute
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Peking University Cancer Hospital & Institute at 23 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 4 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keneng Chen, M.D. (+86 13501085973, chenkeneng@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of 5% body weight loss on Day 30 (time frame: Day 30 after discharge). 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 23 Jan 2018.