Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk.
Charles E Matthews, Steven C Moore, Hannah Arem...
https://pubmed.ncbi.nlm.nih.gov/31877085/Actively Recruiting
Led by Xiaoqin Luo · Updated on 2025-07-28
360
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating whether short-term personalized nutritional support combined with structured health education can improve nutritional status, quality of life, and clinical outcomes in patients who have undergone surgery for colorectal cancer. This trial focuses on patients with non-metastatic colorectal cancer stages IIa, IIb, and IIIa, addressing the common problem of malnutrition and poor physical condition during treatment that may affect recovery and survival. Participants are randomly assigned to one of four groups nutritional enhancement plus health education, health education alone, nutritional enhancement alone, or standard care without these interventions. Nutritional support includes personalized dietary counseling and oral or parenteral nutritional supplements tailored to individual energy and protein needs. Health education is delivered digitally via an Internet Plus platform with weekly videos and expert guidance, focusing on nutrition, exercise, and psychological well-being. The intervention phase lasts 14 days, followed by a 12-month follow-up and annual assessments up to 5 years. During the study, participants undergo assessments of nutritional status, quality of life, symptom scores, and survival at multiple time points including baseline, post-intervention, and several months afterward. Biological samples such as blood, stool, and tumor tissue are collected for analysis of metabolic, immune, and microbiome changes. Researchers also monitor treatment side effects, patient adherence, psychological health, and healthcare utilization. This comprehensive follow-up up to 5 years aims to provide evidence for integrating nutrition and health education into colorectal cancer care and to uncover biological mechanisms behind treatment effects.
CONDITIONS
Short-Term Nutritional Enhancement Combined With Health Education in Postoperative Colorectal Cancer Patients: A Randomized Controlled Trial
X
Xiaoqin Luo, Ph.D
H
Hexiang Yang, Ph.D
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Xiaoqin Luo
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive short-term nutritional enhancement and/or structured health education for 14 days after surgery. Nutritional enhancement includes personalized oral or parenteral supplements tailored to individual energy and protein needs. Health education is delivered via a digital platform with weekly videos and interactive content focusing on nutrition, exercise, and psychological well-being.
Regular assessments and adjustments every 3 days during the 14-day intervention
Duration - 12 months and annually up to 5 years
Participants are followed for 12 months and annually up to 5 years to monitor clinical outcomes, nutritional status, quality of life, and survival. Biological samples and health assessments are collected during this period to evaluate long-term effects and mechanisms of the interventions.
Visits at baseline, after intervention, 1, 2, 3, 6, and 12 months; annual visits thereafter up to 5 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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Lead Sponsor