Clinical trial NCT06250166: Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design
Official title: Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Nutrition Poor
Gastrointestinal Complication
Quality of Life
Lead sponsor: National Cancer Institute, Malaysia
Sponsor class: OTHER_GOV
First posted: 2024-02-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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)

Primary outcomes:
measure: Change from baseline in mean Prognostic Nutritional Index at 12 weeks
timeFrame: Change from baseline to week 12
measure: Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks
timeFrame: Change from baseline to week 12
measure: Change from baseline in mean platelet-lymphocyte ratio at 12 weeks
timeFrame: Change from baseline to week 12
Secondary outcomes:
measure: Change from baseline in mean Patient-Generated Subjective Global Assessment score at 12 weeks
timeFrame: Change from baseline to week 12
measure: Change from baseline in mean skeletal muscle Index, body fat mass, extracellular water ratio, phase angle at 12 weeks
timeFrame: Change from baseline to week 12
measure: Change from baseline in mean mid arm muscle area at 12 weeks
timeFrame: Change from baseline to week 12
measure: Change from baseline in mean handgrip strength at 12 weeks
timeFrame: Change from baseline to week 12
measure: Change from baseline in mean quality of Life at 12 weeks
timeFrame: Change from baseline to week 12
measure: Change in mean daily energy and protein intake at 12 weeks
timeFrame: Change from baseline to week 12
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan Kuala Lumpur
city: Putrajaya
country: Malaysia
facility: National Cancer Institute
state: Wilayah Persekutuan Putrajaya
Study officials:
References: