Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-29 @ 1:05 PM
Study NCT ID:
NCT06250166
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-25', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean Prognostic Nutritional Index at 12 weeks', 'timeFrame': 'Change from baseline to week 12', 'description': 'The Prognostic Nutritional Index is used to assess the nutritional status. Respondents are severely malnourished if score less than 40'}, {'measure': 'Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks', 'timeFrame': 'Change from baseline to week 12', 'description': 'Higher score indicates higher level of inflammation'}, {'measure': 'Change from baseline in mean platelet-lymphocyte ratio at 12 weeks', 'timeFrame': 'Change from baseline to week 12', 'description': 'Higher score indicates higher level of inflammation'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in mean Patient-Generated Subjective Global Assessment score at 12 weeks', 'timeFrame': 'Change from baseline to week 12', 'description': '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)'}, {'measure': 'Change from baseline in mean skeletal muscle Index, body fat mass, extracellular water ratio, phase angle at 12 weeks', 'timeFrame': 'Change from baseline to week 12', 'description': '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.'}, {'measure': 'Change from baseline in mean mid arm muscle area at 12 weeks', 'timeFrame': 'Change from baseline to week 12', 'description': 'Respondents develop cachexia if values are less than 32 (male) and 18 (female)'}, {'measure': 'Change from baseline in mean handgrip strength at 12 weeks', 'timeFrame': 'Change from baseline to week 12', 'description': 'Respondents have weak muscle if the values are 27 or less (male) and 16 or less (female)'}, {'measure': 'Change from baseline in mean quality of Life at 12 weeks', 'timeFrame': 'Change from baseline to week 12', 'description': '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'}, {'measure': 'Change in mean daily energy and protein intake at 12 weeks', 'timeFrame': 'Change from baseline to week 12', 'description': 'Higher intake of daily energy and protein indicates improved oral intake'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Nutrition Poor', 'Gastrointestinal Complication', 'Quality of Life']}, 'descriptionModule': {'briefSummary': "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:\n\n1. What are the current eating trends in colorectal cancer patients?\n2. What are the common perceptions of adopting a plant-based diet in colorectal cancer?\n3. Does iPLANT diet plan improve nutritional indices of colorectal cancer patients?\n4. Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status?\n\nParticipants 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.\n\nThe researcher will compare the differences in nutritional outcomes and quality of life between intervention and control groups before and after intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with colorectal cancer, including the sites of caecum, appendix, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, and rectum\n* TNM stage II to IV\n* Receiving chemotherapy\n* Able to take food orally\n\nExclusion Criteria:\n\n* Have cognitive impairments or mental disorders\n* Diagnosed with severe illness, such as chronic kidney disease and chronic obstructive pulmonary disease\n* Within 4 weeks of bowel resection\n* Terminally ill or receive hospice care\n* Receiving enteral or total parenteral nutrition\n* Having inflammatory bowel diseases\n* Having gastrointestinal bleeding or obstruction\n* Pregnancy or breastfeeding\n* Severe anemia (\\<0.8g/dL)\n* ECOG performance score \\>2\n* High stoma output (\\>1500ml per day)'}, 'identificationModule': {'nctId': 'NCT06250166', 'briefTitle': 'Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Institute, Malaysia'}, 'officialTitle': 'Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design', 'orgStudyIdInfo': {'id': '23-00024-WJG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Receive iPLANT diet plan and diet counselling by a qualified dietitian in oncology setting.', 'interventionNames': ['Behavioral: iPLANT diet plan and diet counselling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Receive usual diet counselling only', 'interventionNames': ['Behavioral: Usual diet counselling']}], 'interventions': [{'name': 'iPLANT diet plan and diet counselling', 'type': 'BEHAVIORAL', 'description': "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).", 'armGroupLabels': ['Intervention group']}, {'name': 'Usual diet counselling', 'type': 'BEHAVIORAL', 'description': 'General dietary advices on how to improve oral intake and maintain healthy weight will be provided.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50586', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'SHIN LU NG', 'role': 'CONTACT', 'email': 'krystal_1224@hotmail.com', 'phone': '0172306490'}], 'facility': 'Hospital Kuala Lumpur', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '62250', 'city': 'Putrajaya', 'state': 'Putrajaya', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'SHIN LU NG', 'role': 'CONTACT', 'email': 'krystal_1224@hotmail.com', 'phone': '0172306490'}], 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 2.93527, 'lon': 101.69112}}], 'centralContacts': [{'name': 'SHIN LU NG, master', 'role': 'CONTACT', 'email': 'krystal_1224@hotmail.com', 'phone': '0172306490'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Malaysia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Krystal Ng Lu Shin', 'investigatorAffiliation': 'National Cancer Institute, Malaysia'}}}}