| CTRI Number |
CTRI/2025/11/097935 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Can Healthy Lifestyle Changes Help People With Early Colon Cancer Get Better Outcomes |
|
Scientific Title of Study
|
Association of lifestyle factors with clinical outcomes in newly diagnosed non metastatic colorectal cancer and the role of lifestyle intervention |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prem Venkatt |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Medical Oncology
JIPMER
Gorimedu
Pondicherry
PONDICHERRY
605001
India |
| Phone |
9489992666 |
| Fax |
|
| Email |
premthangavel94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Kayal |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Medical Oncology
JIPMER
Gorimedu
Pondicherry
PONDICHERRY
605001
India |
| Phone |
7598118439 |
| Fax |
|
| Email |
kayalsmita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prem Venkatt |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Medical Oncology
JIPMER
Gorimedu
Pondicherry
PONDICHERRY
605001
India |
| Phone |
9489992666 |
| Fax |
|
| Email |
premthangavel94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Gorimedu
Puducherry
605001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prem Venkatt |
JIPMER |
Department of Medical Oncology
Regional Cancer Centre
Pondicherry
PONDICHERRY |
9489992666
premthangavel94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cancer survivorship healthy lifestyle implementation program |
A cohort of 30 patients from Part I (which is a observational study) shall be enrolled in the pilot study , 2 weeks to 8 weeks after completion of treatment, for colorectal cancer based on purposive sampling.An interventional program- the CshLIP (Cancer survivorship healthy Lifestyle Intervention Pro-gram) based on the modified AICR will be done for those patients enrolled in Part -II of the study. This program will focus on the domain where the patient needs an intervention. For example- if a patient has a healthy dietary lifestyle but is physically inactive, intervention shall be done for the domain of physical activity |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
PART-I
Inclusion Criteria:
1.Newly diagnosed Early/Locally advanced Stage I to III CRC patients with histopathologically confirmed diagnosis
2.Adults (more than or equal to 18 years)
3.ECOG less than or equal to 3
PART-II
Inclusion criteria:
1.Non- metastatic colorectal cancer patients who have completed treatment within the past 2 to 8 weeks
2.Age more than or equal to 18 years
3.ECOG PS more than or equal to 2
|
|
| ExclusionCriteria |
| Details |
PART-I
1.Non-consenting patients
2.Patients who cannot read or write Tamil or English
3.Pregnant or Lactating Women
4.Patients with Previous Malignancies that may confound the results
PART-II
1.Patients with uncontrolled diabetes, severe cardiovascular disease, or advanced chronic kidney/liver disease that may impact lifestyle changes.
2.Patients with dementia, psychiatric disorders, or conditions affecting their ability to adhere to lifestyle interventions.
3.Non- consenting patients
4.Patients who cannot read or write Tamil or English
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Part I- Assessment of lifestyle factors in newly diagnosed colorectal cancer patients
Part II- Pilot study of lifestyle interventions in treated cases of colorectal cancer patients |
Baseline, 3 months, 6 months upto end of study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This 2-year prospective study at JIPMER aims to assess lifestyle factors and implement a structured lifestyle intervention in patients with non-metastatic (stage I–III) colorectal cancer. In the first phase, eligible patients will be recruited and evaluated using a structured proforma capturing clinical, anthropometric, and metabolic data, along with the Composite Lifestyle Mapping Index (CLeMI) questionnaire to assess diet, physical activity, sedentary behavior, substance use, stress, and sleep. Quality of life will be measured using the EORTC QLQ-C30 and CR-29 tools. Participants will be followed at 3 and 6 months for lifestyle reassessment, quality-of-life changes, and clinical outcomes including recurrence, disease-free survival, and overall survival. The second phase is a pilot study of the Cancer Survivorship Healthy Lifestyle Implementation Program (CshLIP)—a culturally adapted lifestyle modification program based on AICR recommendations. Thirty treated colorectal cancer patients will receive individualized lifestyle counselling, reinforced through periodic telephonic follow-up and in-person review at 3 months. The primary outcomes will be adherence to the intervention and improvement in lifestyle scores at 3 and 6 months |