Table 5 Clinical trials of diet and prebiotics interventions on immunotherapy
Phase (Trial ID) | Patients (n) | Cancer type | Microbial Intervention | Immunotherapy treatment | Primary outcomes measures | Ref. |
|---|---|---|---|---|---|---|
II (NCT06466434) | 75 | Melanoma | PreFED | ICI | Efficacy | |
II (NCT04645680) | 50 | Melanoma | Dietary supplement: isocaloric high-fiber | αPD-1 mAb and/or αCTLA-4 mAb | Change in the gut microbiome | |
NA (NCT06298734) | 40 | Melanoma | Dietary supplement: EX/DT/COMB | αPD-1 mAb /αCTLA-4 mAb /αLAG-3 mAb | Change in gut microbiome diversity | |
NA (NCT06236360) | 30 | Melanoma | Dietary supplement: MINI-MD | αPD-1 mAb plus αCTLA-4 mAb | Efficacy | |
NA (NCT04866810) | 80 | Melanoma | Behavioral: high fiber, plant based diet+exercise | Immunotherapy | Feasibility | |
II (NCT03709147) | 64 | Lung cancer | Dietary supplement: FMD | Chemo-immunotherapy | PFS | |
NA (NCT03700437) | 12 | NSCLC | Dietary supplement: FMD | Chemo-immunotherapy | Feasibility, compliance | |
NA (NCT06671613) | 66 | NSCLC | Dietary supplement: FMD | αPD-1/PDL-1 mAb | Feasibility, compliance | |
II (NCT05763992) | 145 | TNBC | Fasting-Like Approach | Chemo-immunotherapy | Rate of pCR | |
NA (NCT06610097) | 30 | TNBC | Dietary supplement: high fiber | Chemo-immunotherapy | Species and diversity | |
NA (NCT05083416) | 29 | HNSCC | Behavioral: PNF | ICI | Rates of PNF compliance, change in gut microbiome and microbial metabolites | |
NA (NCT06391099) | 60 | Melanoma, Kidney Cancer | Dietary supplement: KD | αPD-1 mAb | AEs, adherence | |
NA (NCT05356182) | 30 | Solid tumors | Low protein diet | ICI | Feasibility | |
NA (NCT05832606) | 60 | Solid tumors | Dietary supplement: high fiber | αPD-1 mAb and/or αCTLA-4 mAb | Feasibility, irAEs | |
NA (NCT06438588) | 10 | Solid tumors | Dietary supplement: FMD | ICI | Symptom Measurement, AEs, physical function, QOL, fecal calprotectin |
