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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Nutrition Poor; Gastrointestinal Complication; Quality of Life
• Interventions: Behavioral: iPLANT diet plan and diet counselling; Behavioral: Usual diet counselling

• Registration Number: NCT06250166
• Lead Sponsor: National Cancer Institute, Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-08
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	iPLANT diet plan and diet counselling	Receive iPLANT diet plan and diet counselling by a qualified dietitian in oncology setting.
Control group	Usual diet counselling	Receive usual diet counselling only

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks	Change from baseline to week 12	Higher score indicates higher level of inflammation
Change from baseline in mean platelet-lymphocyte ratio at 12 weeks	Change from baseline to week 12	Higher score indicates higher level of inflammation
Change from baseline in mean Prognostic Nutritional Index at 12 weeks	Change from baseline to week 12	The Prognostic Nutritional Index is used to assess the nutritional status. Respondents are severely malnourished if score less than 40

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean handgrip strength at 12 weeks	Change from baseline to week 12	Respondents have weak muscle if the values are 27 or less (male) and 16 or less (female)
Change in mean daily energy and protein intake at 12 weeks	Change from baseline to week 12	Higher intake of daily energy and protein indicates improved oral intake
Change from baseline in mean mid arm muscle area at 12 weeks	Change from baseline to week 12	Respondents develop cachexia if values are less than 32 (male) and 18 (female)
Change from baseline in mean Patient-Generated Subjective Global Assessment score at 12 weeks	Change from baseline to week 12	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 in mean skeletal muscle Index, body fat mass, extracellular water ratio, phase angle at 12 weeks	Change from baseline to week 12	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 in mean quality of Life at 12 weeks	Change from baseline to week 12	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

Trial Locations

Locations (2)

National Cancer Institute; 🇲🇾 Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia

Hospital Kuala Lumpur; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia