Effect of Nutritional Formula (Protison) on Various Cancer Patients: A Randomized Clinical Trial
Study Details
Study Description
Brief Summary
Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. Hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-PCNF (rich in ω-3 FA, fibers, MTC, BCAA, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. Hence, oncologic nutritionist strongly recommends cancer patients (with cachexia) to consume a diet rich in protein and dietary fibers along with balanced essential micronutrients like vitamins and minerals (Van Norren et al., 2009; Yeh et al., 2013). From the above statement, it cleared that nutritional support is a crucial aspect of multi-modal cancer care, by improving the overall health status by suppressing various adverse events as well as enhance treatment regimen for a speedy recovery. Hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-PCNF (rich in ω-3 FA, fibers, MTC, BCAA, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PCNF Totally 42 cancer patients with poor nutritional status under nasogastric (NG) tube feeding was recruited and administered with the commercial nutritional formula (PCNF; 237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks (84 days). |
Dietary Supplement: Protison cancer nutritional formula (PCNF)
PCNF (237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Calorie intake [12 weeks]
The mean value of calorie intake (energy) were significantly increased in PCNF supplemented subjects
- Anthropometric parameters [12 weeks]
BMI were markedly improved in PCNF intook subjects
- Protein nutritional assessment index or nutritional status [12 weeks]
Protein nutritional assessment index (total protein, pre-albumin , and transferrin) were significantly improved
Secondary Outcome Measures
- Glycemic indices [12 weeks]
No significant changes in any of the glycemic indices or lipid profile PCNF groups
Eligibility Criteria
Criteria
Inclusion Criteria:
- only hospitalized cancer patients with risk of malnutrition and underweight (confirmed with BMI, protein, and pre-albumin level) and must be under NG tube feeding.
Exclusion Criteria:
- avoiding cancer patients under critical conditions, with cardiac, renal, and hepatic disorders. Also, heavy smokers, chronic or chain smokers, and pregnant/lactating women were not included.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chung Shan Medical University | Taichung city | Taichung | Taiwan | 40201 |
Sponsors and Collaborators
- Chung Shan Medical University
Investigators
- Principal Investigator: Chin-Kun Wang, Ph.D, Chung Shan Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS17106