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

NCT ID: NCT03545490

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-06-30

Brief Summary

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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).

Detailed Description

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This clinical trial will be conducted in a single-center, prospective, and randomized manner. In this protocol, the standard radio(chemo)therapy duration is 6-7 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 when post-operative radio(chemo)therapy completes. Standard enteral nutrition intervention (SEN) refers to starting of enteral nutrition intervention on demand during (chemo)radiotherapy. Nutritional supplementation was given either through the oral route (Cohort 1) or tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy, cohort 2). 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 addition to nutritional supplements.

Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cohort 1: nutritional supplements are given through oral route Cohort 2: nutritional supplements are given by tube feeding
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cohort 1-intervention

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

Group Type EXPERIMENTAL

Early nutritional intervention

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Early nutritional intervention

Intervention Type 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 2- Intervention

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

Group Type EXPERIMENTAL

Early nutritional intervention

Intervention Type 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 2- Control

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

Group Type ACTIVE_COMPARATOR

Early nutritional intervention

Intervention Type 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.

Interventions

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Early nutritional intervention

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role lead

Responsible Party

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Guopei Zhu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guopei Zhu

Role: STUDY_DIRECTOR

Shanghai 9th people hospital

Locations

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Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 39903480 (View on PubMed)

Other Identifiers

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ANCH 1601

Identifier Type: -

Identifier Source: org_study_id