Effect of FMD on Colorectal Cancer Patients

NCT ID: NCT05384444

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fasting Mimicking Diet Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Concealed allocation: the statisticians formulate the randomization scheme and generates the random number.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Allocation concealment:an independent researcher implements the randomized allocation scheme to ensure that the subjects and the researchers who screen the subjects are unable to know the subsequent subjects in advance

Study Groups

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Fasting mimicking diet

The cyclic FMD diet consists of a 5 day regimen: day 1 diet of the diet supplies \~1000 kcal (10% protein, 56% fat, 34% carbohydrate), day 2-5 are identical in formulation and provide 800 kcal (9% protein, 44% fat, 47% carbohydrate). At least 4 cyclic FMDs will be performed after operation.

Group Type EXPERIMENTAL

Fasting mimicking diet

Intervention Type OTHER

The fasting mimicking diet consists of a 5 day regimen: day 1 diet of the diet supplies \~1000 kcal (10% protein, 56% fat, 34% carbohydrate), day 2-5 are identical in formulation and provide 800 kcal (9% protein, 44% fat, 47% carbohydrate). At least 4 cyclic FMDs will be performed after operation.

regular diet

regular diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fasting mimicking diet

The fasting mimicking diet consists of a 5 day regimen: day 1 diet of the diet supplies \~1000 kcal (10% protein, 56% fat, 34% carbohydrate), day 2-5 are identical in formulation and provide 800 kcal (9% protein, 44% fat, 47% carbohydrate). At least 4 cyclic FMDs will be performed after operation.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Cancer Hospital, China

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Changhong Miao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miaomiao Guo, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Meilin Weng, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

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Fudan University Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Fudan University Shanghai Cancer center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Fudan University,ZhongShan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Changhai Hospital, Naval Medical University,

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai First People's Hospital,Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Tongji Hospital,Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Changhong Miao, PhD

Role: CONTACT

+8613621756315

Changhong Miao, PhD

Role: CONTACT

+8618217755229

Facility Contacts

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Yingwei Wang, PhD

Role: primary

+86-13918690528

Zhirong Sun, PhD

Role: primary

+8618017317650

Changhong Miao, PhD

Role: primary

+86-13621756315

Xiaoming Deng, PhD

Role: primary

+8613817283189

Yimin Qiu, PhD

Role: primary

+86-18121285957

Xiaoqing Zhang, M.D

Role: primary

+8613661452939

Other Identifiers

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B2020-063(2)

Identifier Type: -

Identifier Source: org_study_id

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