Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer

NCT03795493 | Completed

• 1 other identifier: HREBA.CC-18-0657
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Exercise; Nutrition; Caloric Restriction; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Tumor size change after 6 cycles (mm)

  Change in tumor size measured by computerized tomography after 6 cycles.

  0-6 weeks before the first chemotherapy treatment of the first cycle and 1-4 weeks after the last chemotherapy treatment of the last cycle

Secondary Outcomes (2)

• Tumor response to therapy by magnetic resonance imaging (mm²/s)

  0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle

• Tumor size change after 3 cycles (mm)

  0-6 weeks before the first chemotherapy treatment of the first cycle and 1-3 weeks after the last chemotherapy treatment of the third cycle

Other Outcomes (13)

• Left ventricular ejection fraction (%)

  0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle

• Left ventricular global longitudinal strain (%)

  0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle

• Left ventricular mass (g/m²)

  0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle

Study Arms (2)

Intervention Group

EXPERIMENTAL

Standard chemotherapy treatment and oncology care plus short-term diet and exercise intervention.

Behavioral: Short-term diet and exercise intervention

Control Group

NO INTERVENTION

Standard chemotherapy treatment and oncology care.

Interventions

Short-term diet and exercise intervention BEHAVIORAL

Participants assigned to the intervention group will perform both the diet and acute exercise interventions. The interventions will be applied prior to up to six chemotherapy cycles of a consistent protocol. The total number of treatments of a given protocol received prior to treatment conclusion is dependent on patient condition and oncologic care preferences.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stage IV or metastatic breast cancer;
• Measurable metastases.
• Age \>18
• Starting (or having only received one treatment of) any type of intravenously administered chemotherapy;
• Eastern Cooperative Oncology Group (ECOG) Score \< 3
• Oncologist approval to participate
• Able to communicate and read and understand English;
• Willing and able to adhere to the study interventions and assessments;

You may not qualify if:

• Limitations to sustained exercise (including bone metastases in the femur neck);
• Clinical evidence of cachexia (oncologist's discretion, study team will use body mass index \<18.5kg/m² as a flag to highlight concern to treating oncologist);
• Body mass \>109 kg at time of enrollment;
• Diabetes;
• Severe food allergies;
• History of eating disorder (diagnosed or self-reported);
• Strict diet restrictions including vegetarian or vegan;
• Unable to provide informed consent (i.e. cognitive impairment);
• Supplemental oxygen requirement;
• Uncontrolled pleural effusions (oncologists approval if pleural effusions exists and are controlled);
• Bilirubin \>30 umol/L;
• Creatinine \>120 umol/L;
• Pregnant;
• Contraindications to 3T MRI for research purposes

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Cancer Society (CCS): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (1)

• Kirkham AA, King K, Joy AA, Pelletier AB, Mackey JR, Young K, Zhu X, Meza-Junco J, Basi SK, Hiller JP, Brkin T, Michalowski B, Pituskin E, Paterson DI, Courneya KS, Thompson RB, Prado CM. 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 chemotherapy versus usual care. BMC Cancer. 2021 Oct 10;21(1):1093. doi: 10.1186/s12885-021-08808-2.

  PMID: 34629067 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Carla Prado, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Richard Thompson, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: January 7, 2019
• Study Start: April 23, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

CA (1)