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Table 1 Three clinical trials assessing a ketogenic diet as an adjuvant therapy for breast cancer

From: Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial

Identifiers and status

First posted

Design

Participants

Interventions

Follow-up

Primary outcomes

NCT03962647; not yet recruiting

24 May 2019

Single-group assignment, clinical trial

30 patients, ER+ breast cancer

Experimental: 2-week ketogenic diet

After 2 weeks of a ketogenic diet

Patients who complete the dietary intervention

NCT03535701; recruiting

24 May 2018

Non-randomized, clinical trial

15 patients with stage IV breast cancer (KETO-CARE)

Active comparator:aArm I (standard of care);

Experimental: arm II (standard of care, ketogenic diet)

Baseline up to 26 weeks

Adherence and compliance to the ketogenic diet;

Changes in psychosocial measures;

Changes in physiological outcomes

NCT02092753; completed

20 March 2014

Non-randomized, clinical trial

150 patients with breast cancer during the rehabilitation phase

Placebo comparator: standard diet;

Experimental: ketogenic diet;

Experimental: logi diet

20 weeks spanning 3 phases: 3 weeks of stationary intervention, 16 weeks of outhouse phase, and 1 final week of stationary intervention

Quality of life. This will be assessed by comparing the results of the EORTC QLQ-30 and the QLQ-BR23 questionnaires