Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

Cancer of Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400552
• Other study ID #: IMU R204/2017
• Status: Completed
• Phase: N/A
• Start date: December 26, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: International Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer Colon
• Cancer of Breast

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
Malaysia	International Medical University	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
International Medical University	Kotra Pharma (M) Sdn Bhd

Country where clinical trial is conducted

Malaysia, 

Outcome

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