Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objectives: The primary purpose of this study is to evaluate the effect of a behavioural intervention involving supported time-restricted eating (TRE), diet quality improvements, and reduced sedentary time versus usual cancer and nutrition care in BC patients receiving chemotherapy treatment on ectopic fat, cardiometabolic profile, and chemotherapy outcomes. The investigators hypothesize that the intervention will attenuate the growth of ectopic fat during chemotherapy and reduce chemotherapy symptoms.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Female biological sex at birth

• \>18 years

• Diagnosis of stage I, II, or III breast cancer

• starting neoadjuvant or adjuvant intravenous chemotherapy

• ECOG \<3;

• Oncologist approval to participate;

• English speaking (all study materials and study staff will be in English)

• Willing and able to adhere to study intervention

Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
University of Toronto
RECRUITING
Toronto
Contact Information
Primary
Rachel Sherrington, Bkin
rsherrin@ualberta.ca
780-668-1669
Time Frame
Start Date: 2024-03-13
Estimated Completion Date: 2027-06
Participants
Target number of participants: 65
Treatments
Experimental: Time-Restricted Eating and Sedentary Time Reduction
Group 1 (Experimental intervention): Participants assigned to this group will receive standard chemotherapy treatment plus a dietary program, and sedentary time reduction strategies, program and a Fitbit monitor. If you are randomized into this group, you will be asked to follow TRE, will receive nutritional education and individualized recommendations on improving diet quality and healthy eating practices, and given to strategies to work towards reducing sedentary time. These components will be gradually introduced over the 24-week program.
No_intervention: Nutrition and Exercise Guidelines
Group 2 (Non-experimental intervention): Participants randomized to this group will receive standard chemotherapy treatment plus a single, group-based nutrition during cancer class, as well as a copy of Canada's Food Guide, physical activity guidelines, and a Fitbit monitor. You will be asked to only make dietary changes if they are recommended within the class or by your doctor, and to maintain your usual timing and number of meals consumed per day. Throughout the 24-week period, you will receive seven brief phone calls from a study staff member to ask about your symptoms and provide support. After the end of the study, participants in this group will be offered a one-one-one counselling session with a registered dietitian.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: University of Alberta

This content was sourced from clinicaltrials.gov