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

National Cancer Institute, Malaysia

Status: Enrolling

Conditions: Gastrointestinal Complication; Quality of Life; Nutrition Poor; Colorectal Cancer

Treatments: Behavioral: iPLANT diet plan and diet counselling; Behavioral: Usual diet counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT06250166

23-00024-WJG

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Intervention group

Experimental group

Description:

Receive iPLANT diet plan and diet counselling by a qualified dietitian in oncology setting.

Treatment:

Behavioral: iPLANT diet plan and diet counselling

Control group

Active Comparator group

Description:

Receive usual diet counselling only

Treatment:

Behavioral: Usual diet counselling