Table 2.
| Status | Study title | Conditions | Interventions | Design | Primary endpoint | Estimated enrolment | Actual start date |
|---|---|---|---|---|---|---|---|
| Recruiting NCT04248998 |
Calorie Restriction With or Without Metformin in Triple Negative
Breast Cancer BREAKFAST trial |
Triple-negative breast cancer | FMD with or without Metformin | RCT | Rate of pCRs | 90 participants | 5 May 2020 |
| Recruiting NCT03162289 |
Intermittent Fasting Accompanying Chemotherapy in Gynecological
Cancers (FIT2) |
Breast cancer and ovarian cancer | Fasting: fasting regime of 60–72 h (36–48 h before and 24 h
after CT) Vegan [60–72 h vegan diet with sugar restriction (36–48 h before and 24 h after CT)] |
RCT | Summarized change in FACT-G score | 150 participants | 10 May 2017 |
| NCT00936364 | Short-Term Fasting: Impact on Toxicity | Malignant solid tumors | STF/modified fast fasting | RCT | Identification of the longest duration of fasting which is safe | 70 participants | 9 July 2009 |
| Active, not recruiting NCT02710721 |
Clinical Study on the Efficacy of Fasting and Nutritional Therapy as a Complementary Treatment of Advanced Metastatic Prostate Cancer Undergoing Chemotherapy—an Exploratory Randomized Controlled Trial | Castration-resistant prostate cancer or hormone-sensitive metastatic prostate cancer with high disease burden | A 60-h-modified fasting (36 h before and 24 h after chemotherapy) with a dietary energy supply 350–400 kcal per day (Chemolieve) | RCT | Summarized change in FACT score from baseline to Day 8 after each chemotherapy | 60 participants | April 2016 |
| Unknown NCT04027478 |
Can Fasting Decrease the Side Effects of Chemotherapy | Patients undergoing chemotherapy with Taxol/carboplatin planned for at least six cycles | FMD consisting of 10 kcal/kg/day and including 50% fat, 40% carbohydrates, and no more than 10% protein | RCT | Grade 2–4 nausea when patients are in the FMD sequence versus the non-fasting sequence | 39 participants | 1 September 2019 |
| New NCT05327608 |
Intermittent Fasting for the Improvement of Outcomes in Patients With Stage I–III Breast Cancer Receiving Chemotherapy Before Surgery | Stage I–III breast cancer receiving chemotherapy before surgery | STF Chemotherapy |
Interventional (Clinical Trial) Single Group Assignment |
Proportion of patients that can adhere to intermittent fasting | 50 participants | 1 May 2022 |
| Enrolling by invitation NCT04247464 |
Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients | Colorectal carcinoma | Fasting Chemotherapy |
RCT | Changes in the CTC-AE 5.0 toxicity table score | 100 participants | 23 September 2020 |
| Recruiting NCT03700437 |
Randomized Controlled Pilot Study to Evaluate Fasting-mimicking Diet in Patients Receiving Chemo-immunotherapy for Treatment of Metastatic Non-small-Cell Lung Cancer | Stage IV lung adenocarcinoma treated with carboplatin/pemetrexed and pembrolizumab | Chemolieve® for 3 days prior to and on the day of chemo-immunotherapy during the first four cycles | Interventional (Clinical Trial) Single Group Assignment |
Proportion of the patients who can finish the FMD without serious AEs | 12 participants | 2 November 2018 |
| Unknown NCT03595540 |
Phase II Clinical Study of a Fasting-Mimicking Diet in Patients Undergoing Oncologic Treatment | Solid or hematologic tumors undergoing active treatment | Prolon by L-Nutra concomitantly with standard antitumor therapies | Interventional (Clinical Trial) Single Group Assignment |
Percentage of prescribed diet consumed and intake of any extra food | 60 participants | 22 November 2017 |
ClinicalTrials.gov. Available online: Search of: chemotherapy, fasting | Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Unknown status Studies | Cancer | Adult - List Results – ClinicalTrials.gov accessed on 01 June 2022.
FACT-G: Functional Assessment of Cancer Therapy – General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQoL in cancer patients: Physical, social, emotional, and functional well-being.
AEs, adverse events; CTC-AE, Common Terminology Criteria for Adverse Event; FMD, fasting mimicking diet; pCRs, pathologic complete responses; RCT, randomized controlled trial; STF, short-term fasting.