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NCT Number: NCT04400552

Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

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.

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Key information

Conditions

Cancer of Breast Breast Diseases Breast Neoplasms Cancer Colon Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Medical University

Kuala Lumpur, 57000, Malaysia

About this study

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:

  • To evaluate the baseline nutritional status of cancer patients undergoing elective surgery
  • To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients
  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONS Pre-op + ONS Post-op

Dietary Supplement

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.

ONS Pre-op + ONS Post-op + ONS Post-op 3 months

Dietary Supplement

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.

Usual intake Pre-op + ONS Post-op

Dietary Supplement

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

Primary outcomes

  1. Change in body weight

    Time frame: Change from baseline body weight at 4 months

    Anthropometry measurement

  2. Change in body mass index (BMI)

    Time frame: Change from baseline body mass index (BMI) at 4 months

    Anthropometry measurement

  3. 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

  4. 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 outcomes

  1. Change in handgrip force

    Time frame: Change from baseline handgrip force at 4 months

    Handgrip force is a measure of handgrip strength by dynamometer

  2. 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

  3. 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

  4. Change in serum transferrin level

    Time frame: Change from baseline serum transferrin level at 4 months

    Serum transferrin is a measure of nutritional status

  5. Change in hemoglobin level

    Time frame: Change from baseline hemoglobin level at 4 months

    Serum hemoglobin is a measure of nutritional status

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Length of hospital stay

    Time frame: Up to 5 days

    Number of days participants are admitted into the hospital

Sponsors and collaborators

Lead sponsor

IMU University, Malaysia

Other

Collaborators

  • Kotra Pharma (M) Sdn Bhd

Registry information

Official study title

Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 22, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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