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

NCT03545490 | Completed Phase 2

• 1 other identifier: ANCH 1601
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The target population in the present study is Chinese patients with oral and oropharyngeal cancer who plan to receive radio(chemo)therapy after surgical resection in the outpatient department. Investigators hypothesize that early enteral nutrition intervention, which is initiated 2 weeks before the start of postoperative radio(chemo)therapy treatment and added on demand during radiotherapy, will improve patients' nutritional status, tolerability to the radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of oral nutritional supplements during the course of irradiation treatment. There are two cohorts in this trial, cohort 1 included patients with oral nutritional supplements and cohort 2 included patients with tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy).

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Body weight

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

  10 weeks

Secondary Outcomes (20)

• Body weight

  2weeks,5 weeks, 8 weeks

• Body Mass Index

  10 weeks

• Calf circumference by measure

  5weeks, 10 weeks

• Lean mass measured by Bioelectrical impedance analysis (BIA)

  5weeks 10 weeks

• Fat mass measured by Bioelectrical impedance analysis (BIA)

  5weeks 10 weeks

Study Arms (4)

Cohort 1-intervention

EXPERIMENTAL

Oral supplements are given through oral route 2 weeks before radiotherapy.

Dietary Supplement: Early nutritional intervention

Cohort 1-Control

ACTIVE COMPARATOR

Oral supplements are given through oral route on demand during radiotherapy.

Dietary Supplement: Early nutritional intervention

Cohort 2- Intervention

EXPERIMENTAL

Oral supplements are given by tube feeding 2 weeks before radiotherapy.

Dietary Supplement: Early nutritional intervention

Cohort 2- Control

ACTIVE COMPARATOR

Oral supplements are given by tube feeding on demand during radiotherapy.

Dietary Supplement: Early nutritional intervention

Interventions

Early nutritional intervention DIETARY_SUPPLEMENT

Early nutritional intervention (Ensure) was given two weeks before radiotherapy. Ensure 3 times per day, Mixing 55.8 g or 6 spoons of Ensure with 190 mL of warm water.

Cohort 1-Control; Cohort 1-intervention; Cohort 2- Control; Cohort 2- Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

• Jiang W, Zhang H, Dou S, He Y, Zhu G, Li R. Effectiveness of Early Oral Nutritional Supplementation in Preventing Weight Loss in Head and Neck Cancer Patients Undergoing Postoperative Radiotherapy or Chemoradiotherapy: A Prospective Randomized Controlled Trial. J Am Nutr Assoc. 2025 Aug;44(6):498-507. doi: 10.1080/27697061.2025.2458277. Epub 2025 Feb 4.

  PMID: 39903480 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Guopei Zhu

  Shanghai 9th people hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Cohort 1: nutritional supplements are given through oral route Cohort 2: nutritional supplements are given by tube feeding

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: June 4, 2018
• Study Start: June 1, 2017
• Primary Completion: October 31, 2020
• Study Completion: June 30, 2022
• Last Updated: December 18, 2023

Record last verified: 2020-08

Locations

CN (1)