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Trial Title:
Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design
NCT ID:
NCT06250166
Condition:
Colorectal Cancer
Nutrition Poor
Gastrointestinal Complication
Quality of Life
Conditions: Official terms:
Colorectal Neoplasms
Malnutrition
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
iPLANT diet plan and diet counselling
Description:
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).
Arm group label:
Intervention group
Intervention type:
Behavioral
Intervention name:
Usual diet counselling
Description:
General dietary advices on how to improve oral intake and maintain healthy weight will be
provided.
Arm group label:
Control group
Summary:
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:
1. What are the current eating trends in colorectal cancer patients?
2. What are the common perceptions of adopting a plant-based diet in colorectal cancer?
3. Does iPLANT diet plan improve nutritional indices of colorectal cancer patients?
4. Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of
life without compromising their nutritional status?
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed with colorectal cancer, including the sites of caecum, appendix, ascending
colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid
colon, and rectum
- TNM stage II to IV
- Receiving chemotherapy
- Able to take food orally
Exclusion Criteria:
- Have cognitive impairments or mental disorders
- Diagnosed with severe illness, such as chronic kidney disease and chronic
obstructive pulmonary disease
- Within 4 weeks of bowel resection
- Terminally ill or receive hospice care
- Receiving enteral or total parenteral nutrition
- Having inflammatory bowel diseases
- Having gastrointestinal bleeding or obstruction
- Pregnancy or breastfeeding
- Severe anemia (<0.8g/dL)
- ECOG performance score >2
- High stoma output (>1500ml per day)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Kuala Lumpur
Address:
City:
Kuala Lumpur
Zip:
50586
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
SHIN LU NG
Phone:
0172306490
Email:
krystal_1224@hotmail.com
Facility:
Name:
National Cancer Institute
Address:
City:
Putrajaya
Zip:
62250
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
SHIN LU NG
Phone:
0172306490
Email:
krystal_1224@hotmail.com
Start date:
June 15, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
National Cancer Institute, Malaysia
Agency class:
Other
Source:
National Cancer Institute, Malaysia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06250166
