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| Name | Class |
|---|---|
| Kotra Pharma (M) Sdn Bhd | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONS Pre-op + ONS Post-op | Active Comparator | Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital |
|
| ONS Pre-op + ONS Post-op + ONS Post-op 3 months | Active Comparator | 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 |
|
| Usual intake Pre-op + ONS Post-op | Active Comparator | Follow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Anthropometry measurement | Change from baseline body weight at 4 months |
| Change in body mass index (BMI) | Anthropometry measurement | Change from baseline body mass index (BMI) at 4 months |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in handgrip force | Handgrip force is a measure of handgrip strength by dynamometer | Change from baseline handgrip force at 4 months |
| Change in muscle mass | Muscle mass reported in kilogram is measured by bioelectrical impedance analyser |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winnie SS Chee, PhD | IMU University, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Medical University | Kuala Lumpur | 57000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34732233 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Randomized controlled trial
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| 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 |
|
| Change from baseline muscle mass at 4 months |
| Change in fat mass | Fat mass reported in kilogram is measured by bioelectrical impedance analyser | Change from baseline fat mass at 4 months |
| Change in serum transferrin level | Serum transferrin is a measure of nutritional status | Change from baseline serum transferrin level at 4 months |
| Change in hemoglobin level | Serum hemoglobin is a measure of nutritional status | Change from baseline hemoglobin level at 4 months |
| 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 |
| 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 |
| Change in salivary cortisol level | Salivary cortisol level is a biological marker of stress reaction | Change from baseline salivary cortisol level at 4 months |
| 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 |
| 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 |
| 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 |
| 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 |
| Length of hospital stay | Number of days participants are admitted into the hospital | Up to 5 days |
| D017437 |
| Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |