Clinical trial NCT05384444: Effect of FMD on Colorectal Cancer Patients
Official title: Effect of Perioperative Dietary Restriction Strategy on Postoperative Recovery and Outcomes of Patients With Colorectal Cancer : a Multicenter Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fasting Mimicking Diet
Colorectal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Cancer Hospital, China
name: Huashan Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Tongji Hospital
name: Changhai Hospital
name: Shanghai Zhongshan Hospital
First posted: 2022-05-20
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Concealed allocation: the statisticians formulate the randomization scheme and generates the random number.
Primary purpose: TREATMENT

Brief summary: Extensive preclinical evidence suggests that short-term fasting and fasting mimicking diets (FMDs) can protect healthy cells and render cancer cells more vulnerable to chemotherapy and other therapies. However, fasting is difficult for the old and frail subjects.Therefore, FMDs may be more suitable for postoperative dietary intervention in cancer patients. Colorectal tumors have high glucose consumption, which makes tumor cells very sensitive to changes in nutritional metabolism of the surrounding environment (such as diet restriction / fasting). Previous studies have shown that cyclic FMDs are safe and feasible for cancer patients receiving chemotherapy alone. However, the effects of the FMD in patients under radical surgery for colorectal cancer have not been evaluated so far. This study aims to evaluate the impact of FMDs on postoperative recovery and outcomes of patients with colorectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Age 18 \~ 80 years old
2. Patients undergoing radical colorectal cancer resection for the first time
3. Preoperative clinical tumor stage III
4. ASA grade I-III grade
5. With BMI 19-32 kg/m2
6. Adequate liver function, adequate renal function and normal cardiac function
7. Willing to participate in the research of the subject and agree to follow up regularly

Exclusion Criteria:

1. Evidence of distant metastasis before surgery
2. Before surgery, have received treatment of neoadjuvant chemotherapy
3. Type 1 diabetes or intensive insulin therapy
4. Allergies for FMD content
5. Combined with severe primary diseases such as severe immune system or autoimmune system or long-term using of glucocorticoids or immunosuppressant
6. History of opioid abuse, mental illness or cognitive impairment

Primary outcomes:
measure: Disease-free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: Weight, height and BMI
timeFrame: 3 years
measure: upper arm circumference and waistline
timeFrame: 3 years
measure: heart rate, blood pressure and basal metabolic rate
timeFrame: 3 years
measure: body composition
timeFrame: after randomization, before discharge, before and at the completion of each FMD cycle.
measure: plasma protein
timeFrame: 3 years
measure: Nutritional status
timeFrame: 3 years
measure: Feasibility of the FMD in colorectal cancer patients
timeFrame: 3 years
measure: Quality of life(QOL)
timeFrame: 3 years
measure: Exercise tolerance
timeFrame: 3 years
measure: Postoperative pain
timeFrame: 3 years
measure: Occurrence of clinical complications
timeFrame: 3 years
measure: Neutrophil to Lymphocyte Ratio (NLR)
timeFrame: 3 years
measure: Lymphocyte to Monocyte Ratio (LMR)
timeFrame: 3 years
measure: Systemic immune-inflammation index (SII)
timeFrame: 3 years
measure: Inflammatory factor level
timeFrame: 3 years
measure: T Lymphocyte cell count
timeFrame: 3 years
measure: insulin-like growth factor-I (IGF-I)
timeFrame: 3years
measure: Glucose
timeFrame: 3years
measure: insulin
timeFrame: 3years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer center
state: Shanghai
city: Shanghai
country: China
facility: Fudan University,ZhongShan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital, Naval Medical University,
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital,Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongji Hospital,Tongji University
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Miaomiao Guo, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Zhongshan Hospital
name: Meilin Weng, PhD
role: PRINCIPAL_INVESTIGATOR
References: