Malnutrition Clinical Trial
Official title:
Is Correction of Malnutrition Sufficient to Improve Low Physical Function Before Elective Colorectal Cancer Surgery? A Randomized Controlled Trial of Nutrition vs Nutrition and Exercise Prehabilitation
Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions), 60% of older elective colorectal cancer surgery patients with poor physical function were unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic cut-point. Compared to the patients that attained >400m 6MWD preoperatively, twice as many of <400m patients were malnourished. Malnutrition has long been associated with worse functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally deficient patients, the etiology for their poor physical function is malnutrition. Correction of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and improve patient outcomes.
The investigators propose a randomized controlled trial of nutrition prehabilitation alone vs nutrition prehabilitation with supportive exercise in patients with malnutrition and 6MWD <400m before elective colorectal surgery. The primary objective, and therapeutic target, will be achievement of minimal clinical important difference for the 6MWD (14m for within group comparisons and 19m between groups). Ability to adhere to the interventions will be monitored. The findings of this study will guide optimal treatment for this vulnerable population by exploring the role of nutrition alone vs. nutrition with exercise to optimize surgical outcomes. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT03268902 -
Early Life Interventions for Childhood Growth and Development In Tanzania
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
| Completed |
NCT04608656 -
Livestock for Health Project
|
N/A | |
| Completed |
NCT06009198 -
Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan
|
N/A | |
| Recruiting |
NCT05417672 -
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
|
||
| Recruiting |
NCT05257980 -
Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial
|
N/A | |
| Completed |
NCT05015647 -
Low Protein Diet in CKD Patients at Risk of Malnutrition
|
N/A | |
| Completed |
NCT03628196 -
A Nutrition-Focused QIP in Outpatient Clinics
|
||
| Enrolling by invitation |
NCT04675229 -
Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
|
||
| Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
| Not yet recruiting |
NCT05860556 -
Sustainable Eating Pattern to Limit Malnutrition in Older Adults
|
||
| Not yet recruiting |
NCT06047054 -
Incidence Rate and Risk Factors of Malnutrition in ICU
|
||
| Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 | |
| Not yet recruiting |
NCT04183075 -
Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
|
N/A | |
| Not yet recruiting |
NCT03150927 -
Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children
|
N/A | |
| Recruiting |
NCT03408067 -
Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients
|
N/A | |
| Recruiting |
NCT02833740 -
Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition
|
N/A | |
| Completed |
NCT02938247 -
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake
|
N/A | |
| Completed |
NCT02938234 -
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake
|
N/A |