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

NCT06250166 | Recruiting

• 1 other identifier: 23-00024-WJG
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

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. 1.What are the current eating trends in colorectal cancer patients?
2. 2.What are the common perceptions of adopting a plant-based diet in colorectal cancer?
3. 3.Does iPLANT diet plan improve nutritional indices of colorectal cancer patients?
4. 4.Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status?

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks

  Higher score indicates higher level of inflammation

  Change from baseline to week 12

• 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 Outcomes (6)

• Change from baseline in mean Patient-Generated Subjective Global Assessment score at 12 weeks

  Change from baseline to week 12

• 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

• Change from baseline in mean mid arm muscle area at 12 weeks

  Change from baseline to week 12

• Change from baseline in mean handgrip strength at 12 weeks

  Change from baseline to week 12

• Change from baseline in mean quality of Life at 12 weeks

  Change from baseline to week 12

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: iPLANT diet plan and diet counselling

Control group

ACTIVE COMPARATOR

Receive usual diet counselling only

Behavioral: Usual diet counselling

Interventions

iPLANT diet plan and diet counselling BEHAVIORAL

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).

Intervention group

Usual diet counselling BEHAVIORAL

General dietary advices on how to improve oral intake and maintain healthy weight will be provided.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute, Malaysia: lead

Study Sites (2)

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

RECRUITING

National Cancer Institute

Putrajaya, Putrajaya, 62250, Malaysia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

SHIN LU NG, master

CONTACT

0172306490; krystal_1224@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 8, 2024
• Study Start: June 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)