NCT03795493: DREAM

Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer

Completed NA Last updated 4 December 2024

What this trial tests

NA trial testing Short-term diet and exercise intervention in Breast Cancer in 23 participants. Completed in 31 December 2023.

Timeline

23 April 2019

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	23
Start date	23 April 2019
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Canada

Drugs / interventions tested

• Short-term diet and exercise intervention

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

University of Alberta

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fifty patients with metastatic breast cancer will be randomly assigned to an acute intervention consisting of both aerobic exercise and caloric restriction administered acutely prior to each of six chemotherapy cycles, or to usual care. The aerobic exercise intervention will consist of a single supervised recumbent cycle ergometer session performed concurrent to each chemotherapy infusion. The diet intervention consists of provision of meals freshly prepared in a metabolic kitchen with caloric content equivalent to 50% of measured energy requirements and low carbohydrate content for 48-72 hours prior to each chemotherapy infusion. Tumor outcomes will be assessed via CT scan (tumor size) and MRI (novel marker of tumor regression), while treatment side effects will be assessed by MRI and treatment symptoms and quality of life will be assessed via questionnaire before, during and after up to six chemotherapy cycles of a consistent treatment protocol. Progression-free and overall survival will be tracked for two years after diagnosis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of lipid metabolic reprogramming in tumor microenvironment.
   Yang K, Wang X, Song C, He Z, et al · · 2023 · cited 175× · PMID 37064872 · DOI 10.7150/thno.82920
2. Energy Restriction and Colorectal Cancer: A Call for Additional Research.
   Castejón M, Plaza A, Martinez-Romero J, Fernandez-Marcos PJ, et al · · 2020 · cited 41× · PMID 31906264 · DOI 10.3390/nu12010114
3. Science-Driven Nutritional Interventions for the Prevention and Treatment of Cancer.
   Montégut L, de Cabo R, Zitvogel L, Kroemer G. · · 2022 · cited 32× · PMID 35997502 · DOI 10.1158/2159-8290.cd-22-0504
4. Rationale and design of the Diet Restriction and Exercise-induced Adaptations in Metastatic breast cancer (DREAM) study: a 2-arm, parallel-group, phase II, randomized control trial of a short-term, calorie-restricted, and ketogenic diet plus exercise during intravenous chemothera
   Kirkham AA, King K, Joy AA, Pelletier AB, et al · · 2021 · cited 29× · PMID 34629067 · DOI 10.1186/s12885-021-08808-2
5. Advances in Diet and Physical Activity in Breast Cancer Prevention and Treatment.
   Khalifa A, Guijarro A, Nencioni A. · · 2024 · cited 17× · PMID 39064705 · DOI 10.3390/nu16142262
6. Monitoring and Modulating Diet and Gut Microbes to Enhance Response and Reduce Toxicity to Cancer Treatment.
   Knisely A, Seo YD, Wargo JA, Chelvanambi M. · · 2023 · cited 14× · PMID 36765735 · DOI 10.3390/cancers15030777
7. The advent of precision nutrigeroscience in cancer: from clinic towards molecular biology.
   Gao Z, Liu Y, Cui Y, Han Y, et al · · 2026 · cited 2× · PMID 40850675 · DOI 10.1016/j.jare.2025.08.034
8. Combined Nutritional and Exercise Interventions for Cachexia in Chronic Diseases: A Systematic Review and Meta-analysis Limited to Cancer Cachexia.
   Okamura M, Shirado K, Shirai N, Yagi T, et al · · 2026 · PMID 41884877 · DOI 10.2490/prm.20260012