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

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ClinicalTrials.gov Identifier: NCT03545490
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment Phase
Malnutrition Other: Ensure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : May 31, 2019


Arm Intervention/treatment
Experimental: Intervention oral or tube feeding group
Ensure 3 times/day
Other: Ensure
Ensure(Supplement) +Nutrition education Ensure 3 times per day, Mixing 55.8 g or 6 spoons of Ensure with 190 mL of warm water.
Other Name: Nutrition education

No Intervention: Control oral or tube feeding group
Only nutrition education



Primary Outcome Measures :
  1. Body weight [ Time Frame: 10 weeks ]
    changes of body weight from baseline to Final Visit/Exit.


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 2weeks,5 weeks, 8 weeks ]
    Changes of body weight from baseline to V2, V3 and V4

  2. Body Mass Index [ Time Frame: 10 weeks ]
    Body Mass Index variables at baseline to V2, V3,V4 and Final Visit/Exit

  3. Calf circumference by measure [ Time Frame: 5weeks, 10 weeks ]
    Calf circumference variables at baseline to V3 and Final Visit/Exit

  4. Lean mass measured by Bioelectrical impedance analysis (BIA) [ Time Frame: 5weeks 10 weeks ]
    Lean mass variables at baseline, V3 and Final Visit/Exit

  5. Fat mass measured by Bioelectrical impedance analysis (BIA) [ Time Frame: 5weeks 10 weeks ]
    Fat mass variables at baseline, V3 and Final Visit/Exit

  6. Patient-Generated Subjective Global Assessment/PG-SGA scores [ Time Frame: 5weeks 10 weeks ]

    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

  7. Dietary adherence and intake assessment [ Time Frame: 2weeks,5 weeks, 8 weeks, 10 weeks ]
    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.

  8. Prealbumin by drawing blood [ Time Frame: 5weeks 10 weeks ]
    Prealbumin variables at baseline, V3 and Final Visit/Exit

  9. Albumin by drawing blood [ Time Frame: 5weeks 10 weeks ]
    Albumin variables at baseline, V3 and Final Visit/Exit

  10. Hemoglobin by drawing blood [ Time Frame: 5weeks 10 weeks ]
    Hemoglobin variables at baseline, V3 and Final Visit/Exit

  11. C-reactive protein by drawing blood [ Time Frame: 5weeks 10 weeks ]
    C-reactive protein variables at baseline, V3 and Final Visit/Exit

  12. White blood cell by drawing blood [ Time Frame: 5weeks 10 weeks ]
    White blood cell variables at baseline, V3 and Final Visit/Exit

  13. Peripheral blood lymphocyte by drawing blood [ Time Frame: 5weeks 10 weeks ]
    Peripheral blood lymphocyte variables at baseline, V3 and Final Visit/Exit

  14. CD4+ lymphocytes by drawing blood [ Time Frame: 5weeks 10 weeks ]
    CD4+ lymphocytes variables at baseline, V3 and Final Visit/Exit

  15. CD8+ lymphocytes by drawing blood [ Time Frame: 5weeks 10 weeks ]
    CD8+ lymphocytes variables at baseline, V3 and Final Visit/Exit

  16. Natural killer cell by drawing blood [ Time Frame: 5weeks 10 weeks ]
    Natural killer cell variables at baseline, V3 and Final Visit/Exit

  17. Tolerability to radio(chemo)therapy assessment on treatment status [ Time Frame: 5 weeks, 8 weeks, 10 weeks ]
    Treatment status (e.g., treatment course and doses completed as planned or changed) since last visit at V3, V4 and Final Visit/Exit

  18. Tolerability to radio(chemo)therapy assessment on treatment change due to side effects [ Time Frame: 5 weeks, 8 weeks, 10 weeks ]
    Number of days when treatment is suspended due to side effects since last visit at V3, V4 and Final Visit/Exit

  19. Tolerability to radio(chemo)therapy assessment on complications [ Time Frame: 5 weeks, 8 weeks, 10 weeks ]
    Incidence of radio(chemo)therapy-related complications such as oral mucositis, pneumonia, and shingles since last visit at V3, V4 and Final Visit/Exit

  20. Tolerability to radio(chemo)therapy assessment on staying in hospital due to complications [ Time Frame: 5 weeks, 8 weeks, 10 weeks ]
    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)

  21. 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 [ Time Frame: 5 weeks, 8 weeks, 10 weeks ]
    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

  22. 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 [ Time Frame: 5 weeks, 8 weeks, 10 weeks ]
    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

  23. Health economics assessment on medications treatment due to complications [ Time Frame: 10 weeks ]
    Costs for medications treated for radio(chemo)therapy-related complications during this study

  24. Health economics assessment on hospital charges due to complications [ Time Frame: 10 weeks ]
    Hospital charges for treating radio(chemo)therapy-related complications during this study

  25. Health economics assessment on overall costs for radio(chemo)therapy [ Time Frame: 10 weeks ]
    Overall costs for radio(chemo)therapy

  26. Radio(chemo)therapy treatment effect [ Time Frame: 10 weeks ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545490


Contacts
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Contact: Rongrong LI 86 15801985171 rongrli2003@163.com

Locations
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China, Shanghai
Shanghai ninth people's hospital Recruiting
Shanghai, Shanghai, China, 200011
Contact: Guopei Zhu, M.D.         
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Director: Guopei Zhu Shanghai 9th people hospital

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Responsible Party: Guopei Zhu, Director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT03545490     History of Changes
Other Study ID Numbers: ANCH 1601
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malnutrition
Mouth Neoplasms
Nutrition Disorders
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases