Clinical trial NCT04400552: Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients
Official title: Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Breast
Cancer Colon
Lead sponsor: International Medical University
Sponsor class: OTHER
Collaborators: name: Kotra Pharma (M) Sdn Bhd
First posted: 2020-05-22
Enrollment: 91
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight
timeFrame: Change from baseline body weight at 4 months
measure: Change in body mass index (BMI)
timeFrame: Change from baseline body mass index (BMI) at 4 months
measure: Change in serum albumin level
timeFrame: Change from baseline serum albumin level at 4 months
measure: Change in serum pre-albumin level
timeFrame: Change from baseline serum pre-albumin level at 4 months
Secondary outcomes:
measure: Change in handgrip force
timeFrame: Change from baseline handgrip force at 4 months
measure: Change in muscle mass
timeFrame: Change from baseline muscle mass at 4 months
measure: Change in fat mass
timeFrame: Change from baseline fat mass at 4 months
measure: Change in serum transferrin level
timeFrame: Change from baseline serum transferrin level at 4 months
measure: Change in hemoglobin level
timeFrame: Change from baseline hemoglobin level at 4 months
measure: Change in high sensitivity c-reactive protein (HsCRP) level
timeFrame: Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months
measure: Change in Interleukin-6 (IL-6)
timeFrame: Change from baseline Interleukin-6 (IL-6) at 4 months
measure: Change in salivary cortisol level
timeFrame: Change from baseline salivary cortisol level at 4 months
measure: Change in energy intake
timeFrame: Change from baseline energy intake at 4 months
measure: Change in protein intake
timeFrame: Change from baseline protein intake at 4 months
measure: Change in Pittsburgh Sleep Quality Index (PSQI) scores
timeFrame: Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months
measure: Presence of post-surgical complications
timeFrame: Change from baseline post-surgical complications at 3 months
measure: Length of hospital stay
timeFrame: Up to 5 days
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: International Medical University
Study officials:
affiliation: International Medical University
name: Winnie SS Chee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong TX, Chen ST, Ong SH, Shyam S, Kandasami P, Chee WSS. Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery. Trials. 2021 Nov 3;22(1):767. doi: 10.1186/s13063-021-05716-5.