Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

Overview

The aim of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.

The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is effective on improving nutritional status. An extended period of 3 months post-operative ONS feeding is effective on improving nutritional status as compared to ONS feeding post-operatively during hospital stay only. Perioperative feeding is effective on improving secondary outcomes such as sleep quality, post-operative complications and length of hospital stay.

Full Title of Study: “Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2021

Detailed Description

The main objective of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.

The specific objectives are:

1. To evaluate the baseline nutritional status of cancer patients undergoing elective surgery

2. To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients

3. To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after discharge versus ONS feeding only post-operatively during hospital on nutritional status

4. To evaluate secondary outcomes of perioperative feeding such as sleep quality, post-operative complications and length of hospital stay

Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will be conducted on malnourished cancer patients undergoing elective surgery.

Study duration: The participation duration for each participant is 4 months. The completion of the study will take around 30 months.

Interventions

  • Dietary Supplement: ONS Pre-op + ONS Post-op
    • Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital.
  • Dietary Supplement: ONS Pre-op + ONS Post-op + ONS Post-op 3 months
    • Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months.
  • Dietary Supplement: Usual intake Pre-op + ONS Post-op
    • Participants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital

Arms, Groups and Cohorts

  • Active Comparator: ONS Pre-op + ONS Post-op
    • Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital
  • Active Comparator: ONS Pre-op + ONS Post-op + ONS Post-op 3 months
    • Oral nutrition supplementation (ONS) pre-operatively, post-operatively up to being discharged from hospital and an extended oral nutrition supplementation post-operatively up to 3 months
  • Active Comparator: Usual intake Pre-op + ONS Post-op
    • Follow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital

Clinical Trial Outcome Measures

Primary Measures

  • Change in body weight
    • Time Frame: Change from baseline body weight at 4 months
    • Anthropometry measurement
  • Change in body mass index (BMI)
    • Time Frame: Change from baseline body mass index (BMI) at 4 months
    • Anthropometry measurement
  • Change in serum albumin level
    • Time Frame: Change from baseline serum albumin level at 4 months
    • Serum albumin is an indicator of protein stores to assess nutritional status
  • Change in serum pre-albumin level
    • Time Frame: Change from baseline serum pre-albumin level at 4 months
    • Serum pre-albumin is an indicator of protein stores to assess nutritional status

Secondary Measures

  • Change in handgrip force
    • Time Frame: Change from baseline handgrip force at 4 months
    • Handgrip force is a measure of handgrip strength by dynamometer
  • Change in muscle mass
    • Time Frame: Change from baseline muscle mass at 4 months
    • Muscle mass reported in kilogram is measured by bioelectrical impedance analyser
  • Change in fat mass
    • Time Frame: Change from baseline fat mass at 4 months
    • Fat mass reported in kilogram is measured by bioelectrical impedance analyser
  • Change in serum transferrin level
    • Time Frame: Change from baseline serum transferrin level at 4 months
    • Serum transferrin is a measure of nutritional status
  • Change in hemoglobin level
    • Time Frame: Change from baseline hemoglobin level at 4 months
    • Serum hemoglobin is a measure of nutritional status
  • Change in high sensitivity c-reactive protein (HsCRP) level
    • Time Frame: Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months
    • High sensitivity c-reactive protein (HsCRP) is a measure of inflammatory status
  • Change in Interleukin-6 (IL-6)
    • Time Frame: Change from baseline Interleukin-6 (IL-6) at 4 months
    • Interleukin-6 (IL-6) is a measure of inflammatory status
  • Change in salivary cortisol level
    • Time Frame: Change from baseline salivary cortisol level at 4 months
    • Salivary cortisol level is a biological marker of stress reaction
  • Change in energy intake
    • Time Frame: Change from baseline energy intake at 4 months
    • Energy intake reported in calories is a dietary measure to assess nutritional status
  • Change in protein intake
    • Time Frame: Change from baseline protein intake at 4 months
    • Protein intake reported in gram is a dietary measure to assess nutritional status
  • Change in Pittsburgh Sleep Quality Index (PSQI) scores
    • Time Frame: Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months
    • Pittsburgh Sleep Quality Index (PSQI) scores range from 0-42.Higher scores indicate poorer sleep quality
  • Presence of post-surgical complications
    • Time Frame: Change from baseline post-surgical complications at 3 months
    • Post-surgical complications are indicated by presence of wound infection, chest infection and use of antibiotics, responses are either yes or no
  • Length of hospital stay
    • Time Frame: Up to 5 days
    • Number of days participants are admitted into the hospital

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female from all ethnicity
  • 25 to 65 years
  • BMI not less than 18.0 kg/m²
  • Cancer patients who are confirmed with elective surgery whose co-morbidities are stabilized based on the ASA Physical Status Classification System ASA Class 1 and 2
  • Fulfil at least two characteristics of AND/ ASPEN Diagnosis of Malnutrition These characteristics are insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, localized or generalized fluid accumulation and diminished functional status as measured by handgrip strength.

Exclusion Criteria

  • Patients who require enteral or parenteral feeding
  • Pregnant or lactating
  • On chemotherapy or radiotherapy
  • Total gastrectomy or ileostomy
  • Metastasized cancer, upper gastrointestinal cancer, terminal diseases, decompensated liver or renal disease, major concurrent metabolic problem such as uncontrolled diabetes, dementia
  • On regular steroids prescription

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • International Medical University
  • Collaborator
    • Kotra Pharma (M) Sdn Bhd
  • Provider of Information About this Clinical Study
    • Principal Investigator: Winnie Chee, Principal Investigator – International Medical University
  • Overall Official(s)
    • Winnie SS Chee, PhD, Principal Investigator, International Medical University
  • Overall Contact(s)
    • Winnie SS Chee, PhD, +60327317305, winnie_chee@imu.edu.my

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