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

February 25, 2024 updated by: Krystal Ng Lu Shin, National Cancer Institute, Malaysia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50586
    • Wilayah Persekutuan Putrajaya
      • Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Receive iPLANT diet plan and diet counselling by a qualified dietitian in oncology setting.
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).
Active Comparator: Control group
Receive usual diet counselling only
Behavioral: Usual diet counselling
General dietary advices on how to improve oral intake and maintain healthy weight will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mean Prognostic Nutritional Index at 12 weeks
Time Frame: 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
Change from baseline to week 12
Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks
Time Frame: Change from baseline to week 12
Higher score indicates higher level of inflammation
Change from baseline to week 12
Change from baseline in mean platelet-lymphocyte ratio at 12 weeks
Time Frame: Change from baseline to week 12
Higher score indicates higher level of inflammation
Change from baseline to week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-00024-WJG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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