Trials / Completed
CompletedNCT04400552
Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients
Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 91 (actual)
- Sponsor
- IMU University, Malaysia · Academic / Other
- Sex
- All
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-12-26
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
- First posted
- 2020-05-22
- Last updated
- 2021-08-25
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT04400552. Inclusion in this directory is not an endorsement.