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The goal of this intervention study is to investigate the effectiveness of individualized plant-based diet plan on nutritional indices and clinical outcomes in colorectal cancer patients receiving chemotherapy. The main questions to answer are:
Participants will be randomly assigned into two arms (intervention and control) using opaque envelop system. Intervention group will receive individualized plant-based diet plan and diet counselling, whereas the control group will receive usual diet counselling.
The researcher will compare the differences in nutritional outcomes and quality of life between intervention and control groups before and after intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Receive iPLANT diet plan and diet counselling by a qualified dietitian in oncology setting. |
|
| Control group | Active Comparator | Receive usual diet counselling only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPLANT diet plan and diet counselling | Behavioral | A diet plan which mainly consists of plant-based food will be designed based on participants' energy and protein needs. The counselling covers (1) guidance to achieve energy and protein requirement (2) advice on food to be included in iPLANT diet plan (Mediterranean diet: increase intake of fish and legumes; moderate intake of eggs, dairy, nuts, poultry; limit intake of red meat). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean Prognostic Nutritional Index at 12 weeks | The Prognostic Nutritional Index is used to assess the nutritional status. Respondents are severely malnourished if score less than 40 | Change from baseline to week 12 |
| Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks | Higher score indicates higher level of inflammation | Change from baseline to week 12 |
| Change from baseline in mean platelet-lymphocyte ratio at 12 weeks | Higher score indicates higher level of inflammation | Change from baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean Patient-Generated Subjective Global Assessment score at 12 weeks | The PG-SGA score is derived from components of weight history, food intake, nutritional impact symptoms, and activity function. The possible scores range from 0 (well-nourished) to 37 (worst possible malnourished) | Change from baseline to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SHIN LU NG, master | Contact | 0172306490 | krystal_1224@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Kuala Lumpur | Recruiting | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
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|
| Usual diet counselling | Behavioral | General dietary advices on how to improve oral intake and maintain healthy weight will be provided. |
|
| Change from baseline in mean skeletal muscle Index, body fat mass, extracellular water ratio, phase angle at 12 weeks |
The higher values of skeletal muscle index and phase angle indicate lower risk of malnutrition, whereas higher reading of extracellular water ratio indicates higher risk of malnutrition. Higher body fat mass indicates higher adiposity level. |
| Change from baseline to week 12 |
| Change from baseline in mean mid arm muscle area at 12 weeks | Respondents develop cachexia if values are less than 32 (male) and 18 (female) | Change from baseline to week 12 |
| Change from baseline in mean handgrip strength at 12 weeks | Respondents have weak muscle if the values are 27 or less (male) and 16 or less (female) | Change from baseline to week 12 |
| Change from baseline in mean quality of Life at 12 weeks | EORTC QLQ-CR29 is a validated tool to measure the functional scales and symptomatic level of colorectal cancer that resulted from disease or treatment factors. Possible scores range from 0 to 100, which higher score indicates better functional scale or worse symptomatic level | Change from baseline to week 12 |
| Change in mean daily energy and protein intake at 12 weeks | Higher intake of daily energy and protein indicates improved oral intake | Change from baseline to week 12 |
| National Cancer Institute | Recruiting | Putrajaya | Putrajaya | 62250 | Malaysia |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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