Table 3 Overview of ongoing or unpublished clinical trials of STF combined with chemotherapy or radiotherapy
Trial, site | N | Start | Tumor type and treatment, | STF | Primary endpoint |
|---|---|---|---|---|---|
Non-randomized trial, NCT01175837, Mayo clinic, USA | 12 | 2010 | Distinct malignancies treated with CT | + 24–48 h prior to chemotherapy (distinct regimens) | Safety and feasibility |
Phase II randomized trial, NCT01802346, USC, USA | 120 | 2013 | Breast cancer treated with AC and prostate cancer treated with docetaxel | ±96 h (using FMD) during CT | Toxicity of CT |
Phase II/III Randomized study, NCT02126449, LUMC, the Netherlands | 250 | 2014 | Stage II and III Her2 negative breast cancer treated with AC-T or FEC-T. | ±96 h (using FMD), during AC-T or FEC-T, no corticosteroids in control arm during AC or FEC | Phase II: toxicity of CT Phase III: pCR |
Phase Ib non- randomized trial, NCT02379585, Western Regional Medical Center, USA | 10 | 2015 | Breast cancer | CT ± 48 h STF | pCR |
Randomized trial, NCT02710721, Charite University, Berlin, Germany. | 60 | 2016 | Advanced metastatic prostate cancer | ±60 h (using FMD) during CT vs. Mediterranean diet | QOL |
Randomized crossover study, NTR5731, Erasmus medical center | 18 | 2016 | Metastatic colorectal cancer or other solid tumors receiving irinotecan | Dietary restriction including STF | 25% reduction of the active irinotecan metabolite, SN38, in healthy liver tissue |
Randomized trial, NCT03162289 Charite University, Berlin, Germany. | 150 | 2017 | Ovarian or breast cancer | ±60 h (using FMD) during CT | QOL |
Non-randomized trial, NCT03340935, University of Milan, Italy | 85 | 2017 | Distinct | 5 days (using FMD), 700 kcal a day during cancer treatment | Toxicity of CT |
Non-randomized trial, NCT03595540, Genova, Italy | 60 | 2017 | Distinct | 5 days (using FMD), 700 kcal a day during cancer treatment | Feasibility |
Randomized trial, NCT03709147, Milan, Italy | 88 | 2018 | Lung adenocarcinoma | ± 5 days (using FMD) during CT in combination with metformin | PFS |
Randomized trial. NCT03700437, Indiana University, USA | 40 | 2018 | Non-small cell lung cancer | ± 96 h (using FMD) during carboplatin, pemetrexed and pembrolizumab | DNA damage in and count of circulating tumor cells |
Studies of STF during radiotherapy | |||||
Randomized trial, NCT01754350, Johann Wolfgang Goethe University Hospitals, Germany | 50 | 2013 | Glioblastoma Multiforme | ±72 h during reirradiation | PFS |