Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design

Colorectal Cancer Clinical Trial

Official title:

Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250166
• Other study ID #: 23-00024-WJG
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: National Cancer Institute, Malaysia
• Contact: SHIN LU NG, master
• Phone: 0172306490
• Email: krystal_1224[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Gastrointestinal Complication
• Malnutrition
• Nutrition Poor
• Quality of Life

Intervention

Behavioral:
• iPLANT diet plan and diet counselling
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).
• Usual diet counselling
General dietary advices on how to improve oral intake and maintain healthy weight will be provided.

Locations

Country	Name	City	State
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	National Cancer Institute	Putrajaya	Wilayah Persekutuan Putrajaya

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks	Higher score indicates higher level of inflammation	Change from baseline to week 12
Primary	Change from baseline in mean platelet-lymphocyte ratio at 12 weeks	Higher score indicates higher level of inflammation	Change from baseline to week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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