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Early Enteral Nutritional Supplementation on Patients With Oral Cancer Undergoing Radio(Chemo)Therapy After Surgical

Primary Purpose

Malnutrition

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ensure
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Subject is male or female, between 18 and 70 years old;
  • Subject has clinical or radiological diagnosis of oral cancer (stage III and stage IV), had surgical resection 3 or 4 weeks prior to radio (chemo)therapy, and plans to receive radio (chemo)therapy treatment;
  • Subject has Karnofsky Performance Score (KPS) ≥ 60 and an expected life expectancy ≥ 6 months;
  • Subject is willing to comply with the study protocol, able and willing to consume study product according to the protocol;
  • Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study

Exclusion criteria

  • Except for oral cancer and oropharyngeal cancer, subject has malignant tumors or serious infectious diseases, such as tuberculosis activity, respiratory system, cardiovascular system, urinary system diseases, systemic edema and ascites caused by diseases, etc., cannot participant in study in the opinion of study physician.
  • Subject has dysfunction of liver, kidney or gallbladder, cannot participant in study in the opinion of study physician.
  • Subject has gastrointestinal diseases to cannot tolerate enteral nutrition (such as intestinal bleeding, intestinal obstruction, severe digestive malabsorption, severe nausea and vomiting and diarrhea) that preclude his or her participation in the opinion of study physician;
  • Subject has diabetes
  • Subject has known history of allergy or intolerance to any ingredient in the investigational product;
  • Female subjects are pregnant or plan to get pregnant within a year or are postpartum and non-lactating;
  • Subject has mental illness, cannot understand ICF, unwilling to provide informed consent.
  • Subject has amputation or implanted electronic devices or metal, it may be inappropriate to use BIA to measure body composition
  • Subject is currently or has participated in any clinical trial 2 months prior to enrollment.
  • Subject plans to take nutritional supplements and/or traditional Chinese medicine regularly during study in the opinion of study physician. Multi-vitamin and multi-mineral supplements are exception.

Sites / Locations

  • Shanghai ninth people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention oral or tube feeding group

Control oral or tube feeding group

Arm Description

Ensure 3 times/day

Only nutrition education

Outcomes

Primary Outcome Measures

Body weight
changes of body weight from baseline to Final Visit/Exit.

Secondary Outcome Measures

Body weight
Changes of body weight from baseline to V2, V3 and V4
Body Mass Index
Body Mass Index variables at baseline to V2, V3,V4 and Final Visit/Exit
Calf circumference by measure
Calf circumference variables at baseline to V3 and Final Visit/Exit
Lean mass measured by Bioelectrical impedance analysis (BIA)
Lean mass variables at baseline, V3 and Final Visit/Exit
Fat mass measured by Bioelectrical impedance analysis (BIA)
Fat mass variables at baseline, V3 and Final Visit/Exit
Patient-Generated Subjective Global Assessment/PG-SGA scores
PG-SGA scores, an assessment tool for nutritional status at baseline, V3 and Final Visit/Exit. The Scored PG-SGA includes the four patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function), the professional part (Diagnosis, Age, Metabolic stress, and Physical Exam), the Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition, C = severely malnourished), the total numerical score, and nutritional triage Recommendations (0-1=No intervention required, 2-3 Education and lab values as appropriate, 4-8 Required intervention, >=9 Indicates a critical need for improved and/or nutrient intervention). Subtotal 4 historical components: scoring 0-30+ Weight history and Symptoms scores are additive Food intake and Activities and Function, the highest point score, Professional component: Criteria for condition, scoring 0-6 Metabolic Stress, scoring 0-3 Physical components, scoring 0-3
Dietary adherence and intake assessment
Dietary adherence and intake assessment will be conducted by dietitians at V2, V3, V4 and Final Visit/Exit. Dietary adherence will be determined through comparing subjects' meal plans and actual consumptions as reflected by food diaries.
Prealbumin by drawing blood
Prealbumin variables at baseline, V3 and Final Visit/Exit
Albumin by drawing blood
Albumin variables at baseline, V3 and Final Visit/Exit
Hemoglobin by drawing blood
Hemoglobin variables at baseline, V3 and Final Visit/Exit
C-reactive protein by drawing blood
C-reactive protein variables at baseline, V3 and Final Visit/Exit
White blood cell by drawing blood
White blood cell variables at baseline, V3 and Final Visit/Exit
Peripheral blood lymphocyte by drawing blood
Peripheral blood lymphocyte variables at baseline, V3 and Final Visit/Exit
CD4+ lymphocytes by drawing blood
CD4+ lymphocytes variables at baseline, V3 and Final Visit/Exit
CD8+ lymphocytes by drawing blood
CD8+ lymphocytes variables at baseline, V3 and Final Visit/Exit
Natural killer cell by drawing blood
Natural killer cell variables at baseline, V3 and Final Visit/Exit
Tolerability to radio(chemo)therapy assessment on treatment status
Treatment status (e.g., treatment course and doses completed as planned or changed) since last visit at V3, V4 and Final Visit/Exit
Tolerability to radio(chemo)therapy assessment on treatment change due to side effects
Number of days when treatment is suspended due to side effects since last visit at V3, V4 and Final Visit/Exit
Tolerability to radio(chemo)therapy assessment on complications
Incidence of radio(chemo)therapy-related complications such as oral mucositis, pneumonia, and shingles since last visit at V3, V4 and Final Visit/Exit
Tolerability to radio(chemo)therapy assessment on staying in hospital due to complications
Number of days when patients stay in hospital for treatment of radio(chemo)therapy-related complications since last visit at V3, V4 and Final Visit/Exit (if applicable)
Quality of life assessed by Quality of Life Questionnaire-Core 36 of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-C30 questionnaire
Subjective assessment of physical activity, mood, fatigue and eating status by EORTC Quality of Life QLQ-C30 questionnaire at baseline, V3, V4 and Final Visit/Exit
Quality of life assessed by Quality of Life Questionnaire-Head and Neck 35 questionnaire of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-H&N35
Subjective assessment of physical activity, mood, fatigue and eating status by EORTC Quality of Life QLQ-H&N35 questionnaire at baseline, V3, V4 and Final
Health economics assessment on medications treatment due to complications
Costs for medications treated for radio(chemo)therapy-related complications during this study
Health economics assessment on hospital charges due to complications
Hospital charges for treating radio(chemo)therapy-related complications during this study
Health economics assessment on overall costs for radio(chemo)therapy
Overall costs for radio(chemo)therapy
Radio(chemo)therapy treatment effect
The variable is local tumor control probability assessed at baseline and Final Visit/Exit. Local tumor control probability is defined as the percentage of patients who do not have tumor recurrence in the total patients.

Full Information

First Posted
March 21, 2018
Last Updated
May 22, 2018
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT03545490
Brief Title
Early Enteral Nutritional Supplementation on Patients With Oral Cancer Undergoing Radio(Chemo)Therapy After Surgical
Official Title
A Prospective, Randomized, Clinical Study to Evaluate the Effects of Early Enteral Nutritional Supplementation on Clinical Outcomes in Patients With Oral Cancer Undergoing Radio(Chemo)Therapy After Surgical Resection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The target population in the present study is Chinese patients with oral cancer who plan to receive radio(chemo)therapy after surgical resection in outpatient clinic department. Investigators hypothesize that enteral nutrition intervention, which is initiated 2 weeks before the start of post-operative radio(chemo)therapy treatment and ongoing 2 weeks after the completion of irradiation treatment, will improve patients' nutritional status, tolerability to radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of enteral nutrition during the course of irradiation treatment.
Detailed Description
This clinical trial will be conducted in a single center, prospective, and randomized manner. In this protocol, standard radio(chemo)therapy duration is 6 weeks. Early enteral nutrition intervention (EEN) refers to starting enteral nutrition intervention 2 weeks before post-operative radio(chemo)therapy begins and stopping this intervention 2 weeks after post-operative radio(chemo)therapy completes. Standard enteral nutrition intervention (SEN) refers to starting of enteral nutrition intervention 3 weeks after post-operative radio(chemo)therapy begins and stopping this intervention 2 weeks after post-operative radio(chemo)therapy completes. Nutritional supplementation periods for EEN and SEN groups are 10 weeks and 5 weeks, respectively. Dietitians will design meal plans for both groups of subjects so that their normal diets will provide 25-30 kcal/d/kg body weight in additional to nutritional supplements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention oral or tube feeding group
Arm Type
Experimental
Arm Description
Ensure 3 times/day
Arm Title
Control oral or tube feeding group
Arm Type
No Intervention
Arm Description
Only nutrition education
Intervention Type
Other
Intervention Name(s)
Ensure
Other Intervention Name(s)
Nutrition education
Intervention Description
Ensure(Supplement) +Nutrition education Ensure 3 times per day, Mixing 55.8 g or 6 spoons of Ensure with 190 mL of warm water.
Primary Outcome Measure Information:
Title
Body weight
Description
changes of body weight from baseline to Final Visit/Exit.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Body weight
Description
Changes of body weight from baseline to V2, V3 and V4
Time Frame
2weeks,5 weeks, 8 weeks
Title
Body Mass Index
Description
Body Mass Index variables at baseline to V2, V3,V4 and Final Visit/Exit
Time Frame
10 weeks
Title
Calf circumference by measure
Description
Calf circumference variables at baseline to V3 and Final Visit/Exit
Time Frame
5weeks, 10 weeks
Title
Lean mass measured by Bioelectrical impedance analysis (BIA)
Description
Lean mass variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
Fat mass measured by Bioelectrical impedance analysis (BIA)
Description
Fat mass variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
Patient-Generated Subjective Global Assessment/PG-SGA scores
Description
PG-SGA scores, an assessment tool for nutritional status at baseline, V3 and Final Visit/Exit. The Scored PG-SGA includes the four patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function), the professional part (Diagnosis, Age, Metabolic stress, and Physical Exam), the Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition, C = severely malnourished), the total numerical score, and nutritional triage Recommendations (0-1=No intervention required, 2-3 Education and lab values as appropriate, 4-8 Required intervention, >=9 Indicates a critical need for improved and/or nutrient intervention). Subtotal 4 historical components: scoring 0-30+ Weight history and Symptoms scores are additive Food intake and Activities and Function, the highest point score, Professional component: Criteria for condition, scoring 0-6 Metabolic Stress, scoring 0-3 Physical components, scoring 0-3
Time Frame
5weeks 10 weeks
Title
Dietary adherence and intake assessment
Description
Dietary adherence and intake assessment will be conducted by dietitians at V2, V3, V4 and Final Visit/Exit. Dietary adherence will be determined through comparing subjects' meal plans and actual consumptions as reflected by food diaries.
Time Frame
2weeks,5 weeks, 8 weeks, 10 weeks
Title
Prealbumin by drawing blood
Description
Prealbumin variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
Albumin by drawing blood
Description
Albumin variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
Hemoglobin by drawing blood
Description
Hemoglobin variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
C-reactive protein by drawing blood
Description
C-reactive protein variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
White blood cell by drawing blood
Description
White blood cell variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
Peripheral blood lymphocyte by drawing blood
Description
Peripheral blood lymphocyte variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
CD4+ lymphocytes by drawing blood
Description
CD4+ lymphocytes variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
CD8+ lymphocytes by drawing blood
Description
CD8+ lymphocytes variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
Natural killer cell by drawing blood
Description
Natural killer cell variables at baseline, V3 and Final Visit/Exit
Time Frame
5weeks 10 weeks
Title
Tolerability to radio(chemo)therapy assessment on treatment status
Description
Treatment status (e.g., treatment course and doses completed as planned or changed) since last visit at V3, V4 and Final Visit/Exit
Time Frame
5 weeks, 8 weeks, 10 weeks
Title
Tolerability to radio(chemo)therapy assessment on treatment change due to side effects
Description
Number of days when treatment is suspended due to side effects since last visit at V3, V4 and Final Visit/Exit
Time Frame
5 weeks, 8 weeks, 10 weeks
Title
Tolerability to radio(chemo)therapy assessment on complications
Description
Incidence of radio(chemo)therapy-related complications such as oral mucositis, pneumonia, and shingles since last visit at V3, V4 and Final Visit/Exit
Time Frame
5 weeks, 8 weeks, 10 weeks
Title
Tolerability to radio(chemo)therapy assessment on staying in hospital due to complications
Description
Number of days when patients stay in hospital for treatment of radio(chemo)therapy-related complications since last visit at V3, V4 and Final Visit/Exit (if applicable)
Time Frame
5 weeks, 8 weeks, 10 weeks
Title
Quality of life assessed by Quality of Life Questionnaire-Core 36 of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-C30 questionnaire
Description
Subjective assessment of physical activity, mood, fatigue and eating status by EORTC Quality of Life QLQ-C30 questionnaire at baseline, V3, V4 and Final Visit/Exit
Time Frame
5 weeks, 8 weeks, 10 weeks
Title
Quality of life assessed by Quality of Life Questionnaire-Head and Neck 35 questionnaire of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-H&N35
Description
Subjective assessment of physical activity, mood, fatigue and eating status by EORTC Quality of Life QLQ-H&N35 questionnaire at baseline, V3, V4 and Final
Time Frame
5 weeks, 8 weeks, 10 weeks
Title
Health economics assessment on medications treatment due to complications
Description
Costs for medications treated for radio(chemo)therapy-related complications during this study
Time Frame
10 weeks
Title
Health economics assessment on hospital charges due to complications
Description
Hospital charges for treating radio(chemo)therapy-related complications during this study
Time Frame
10 weeks
Title
Health economics assessment on overall costs for radio(chemo)therapy
Description
Overall costs for radio(chemo)therapy
Time Frame
10 weeks
Title
Radio(chemo)therapy treatment effect
Description
The variable is local tumor control probability assessed at baseline and Final Visit/Exit. Local tumor control probability is defined as the percentage of patients who do not have tumor recurrence in the total patients.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Subject is male or female, between 18 and 70 years old; Subject has clinical or radiological diagnosis of oral cancer (stage III and stage IV), had surgical resection 3 or 4 weeks prior to radio (chemo)therapy, and plans to receive radio (chemo)therapy treatment; Subject has Karnofsky Performance Score (KPS) ≥ 60 and an expected life expectancy ≥ 6 months; Subject is willing to comply with the study protocol, able and willing to consume study product according to the protocol; Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study Exclusion criteria Except for oral cancer and oropharyngeal cancer, subject has malignant tumors or serious infectious diseases, such as tuberculosis activity, respiratory system, cardiovascular system, urinary system diseases, systemic edema and ascites caused by diseases, etc., cannot participant in study in the opinion of study physician. Subject has dysfunction of liver, kidney or gallbladder, cannot participant in study in the opinion of study physician. Subject has gastrointestinal diseases to cannot tolerate enteral nutrition (such as intestinal bleeding, intestinal obstruction, severe digestive malabsorption, severe nausea and vomiting and diarrhea) that preclude his or her participation in the opinion of study physician; Subject has diabetes Subject has known history of allergy or intolerance to any ingredient in the investigational product; Female subjects are pregnant or plan to get pregnant within a year or are postpartum and non-lactating; Subject has mental illness, cannot understand ICF, unwilling to provide informed consent. Subject has amputation or implanted electronic devices or metal, it may be inappropriate to use BIA to measure body composition Subject is currently or has participated in any clinical trial 2 months prior to enrollment. Subject plans to take nutritional supplements and/or traditional Chinese medicine regularly during study in the opinion of study physician. Multi-vitamin and multi-mineral supplements are exception.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongrong LI
Phone
86 15801985171
Email
rongrli2003@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guopei Zhu
Organizational Affiliation
Shanghai 9th people hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai ninth people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guopei Zhu, M.D.

12. IPD Sharing Statement

Learn more about this trial

Early Enteral Nutritional Supplementation on Patients With Oral Cancer Undergoing Radio(Chemo)Therapy After Surgical

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