Colorectal CancerNCT06250166
Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design
A study testing iPLANT diet plan and diet counselling and Usual diet counselling in people with Colorectal Cancer and Nutrition Poor, run by National Cancer Institute, Malaysia at 2 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Nutrition Poor, Gastrointestinal Complication
- What is being tested?
- iPLANT diet plan and diet counselling and Usual diet counselling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesMalaysia
- Study dates
- 15 Jun 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Having gastrointestinal bleeding or obstruction
- Pregnancy or breastfeeding
- Severe anemia (<0.8g/dL)
- ECOG performance score >2
- High stoma output (>1500ml per day)
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites, 2 recruiting
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
SHIN LU NG, 0172306490, krystal_1224@hotmail.com
- Recruiting
National Cancer Institute
Putrajaya, Putrajaya, 62250
SHIN LU NG, 0172306490, krystal_1224@hotmail.com
About this study
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:
- What are the current eating trends in colorectal cancer patients?
- What are the common perceptions of adopting a plant-based diet in colorectal cancer?
- Does iPLANT diet plan improve nutritional indices of colorectal cancer patients?
- Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status?
Read more
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.
- Being tested
- iPLANT diet plan and diet counselling, Usual diet counselling
- Medical subject headings
- Colorectal Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPLANT diet plan and diet counsellingBehavioural
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 counsellingBehavioural
General dietary advices on how to improve oral intake and maintain healthy weight will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Receive iPLANT diet plan and diet counselling by a qualified dietitian in oncology setting. Receives: Behavioral: iPLANT diet plan and diet counselling |
| Control group | Active comparator | Receive usual diet counselling only Receives: Behavioral: Usual diet counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to week 12
Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks
Higher score indicates higher level of inflammation
Measured: Change from baseline to week 12
Change from baseline in mean platelet-lymphocyte ratio at 12 weeks
Higher score indicates higher level of inflammation
Measured: Change from baseline to week 12
Secondary outcomes (6)
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)
Measured: 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
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.
Measured: Change from baseline to week 12
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)
Measured: Change from baseline to week 12
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)
Measured: Change from baseline to week 12
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
Measured: Change from baseline to week 12
Change in mean daily energy and protein intake at 12 weeks
Higher intake of daily energy and protein indicates improved oral intake
Measured: Change from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start15 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Krystal Ng Lu Shin, National Cancer Institute, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250166
- Sponsor's protocol ID
- 23-00024-WJG
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design
- ClinicalTrials.gov ID
- NCT06250166
- Acronym / sponsor ID
- 23-00024-WJG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- National Cancer Institute, MalaysiaOther government
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the current eating trends in colorectal cancer patients?
- What are the common perceptions of adopting a plant-based diet in colorectal cancer?
- Does iPLANT diet plan improve nutritional indices of colorectal cancer patients?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: iPLANT diet plan and diet counsellingReceive iPLANT diet plan and diet counselling by a qualified dietitian in oncology setting. |
| Control group | Active comparator | Behavioral: Usual diet counsellingReceive usual diet counselling only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPLANT diet plan and diet counsellingA 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). | Behavioural | Intervention group |
| Usual diet counsellingGeneral dietary advices on how to improve oral intake and maintain healthy weight will be provided. | Behavioural | Control group |
Primary outcome
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 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 in mean platelet-lymphocyte ratio at 12 weeks
Time frame: Change from baseline to week 12
Higher score indicates higher level of inflammation
6 secondary outcomes
Change from baseline in mean Patient-Generated Subjective Global Assessment score at 12 weeks
Time frame: 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
Change from baseline in mean mid arm muscle area at 12 weeks
Time frame: Change from baseline to week 12
Change from baseline in mean handgrip strength at 12 weeks
Time frame: 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
Change in mean daily energy and protein intake at 12 weeks
Time frame: Change from baseline to week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPLANT diet plan and diet counselling and Usual diet counselling in people with Colorectal Cancer and Nutrition Poor, run by National Cancer Institute, Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SHIN LU NG, master (0172306490, krystal_1224@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean Prognostic Nutritional Index at 12 weeks (time frame: Change from baseline to week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.