表 2. Clinical trials related to FMD in cancer therapy.
FMD在肿瘤治疗中的临床试验
| Trial number | Therapeutic interventions | Cancer type | Number of participants | Status | Primary endpoints | Main study findings |
|
Chemo-immunotherapy + FMD |
Non-small cell lung cancer |
12 |
Completed |
Feasibility and compliance |
No results available |
|
|
Standard antitumour treatment + FMD |
Different tumour types |
101 |
Completed |
G3/4 AE rate |
Safety and feasibility of FMD; reduced glucose and growth factor levels after FMD; favorable reshaping of systemic and intratumor immunity after FMD |
|
|
Standard antitumor treatment + FMD |
Prostate cancer |
40 |
Completed |
Body weight, abdominal circumference, and blood pressure |
Weight loss, abdominal circumference reduction, and blood pressure reduction |
|
|
Active medical treatment + FMD |
Different tumour types |
90 |
Completed |
Feasibility and safety |
Safety and feasibility of FMD; reduced fat mass and plasma insulin, and IGF-1 and leptin levels after FMD |
|
|
Standard neoadjuvant chemotherapy + FMD |
HER2-negative breast cancer |
131 |
Completed |
pCR rate |
No pCR differences among groups; higher radiological response rates in FMD patients; higher Miller & Payne4/5 pathological responses in FMD patients; reduced DNA damage in T lymphocytes of FMD patients |
|
|
Chemotherapy + FMD |
Prostate cancer |
49 |
Completed |
Quality of life changes |
No results available |
|
|
Platinum salt + pemetrexed + pembrolizumab in association to metformin + FMD |
Lung Adenocarcinoma |
64 |
Recruiting |
PFS |
No results available |
|
|
Chemotherapy + FMD |
HER2-negative Breast Cancer |
240 |
Recruiting |
Pathologic and radiologic response rate |
No results available |
|
|
Preoperative chemotherapy + Metformin + FMD |
Triple-negative Breast Cancer |
30 |
Active, not recruiting |
pCR rate |
No results available |
|
|
Radical surgery + FMD |
Colorectal Cancer |
602 |
Recruitment has not started |
DFS |
No results available |
|
|
Chemotherapy + FMD |
Different tumour types |
39 |
Unknown status |
Nausea grade |
No results available |
|
|
Surgery + FMD |
Breast cancer and melanoma |
100 |
Completed |
Absolute/relative changes in PBMCs |
No results available |