Skip to main content
OpenTrials
Completed

NCT Number: NCT04708860

Feasibility of Fasting & Exercise in Pts With HR+ MBC

This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

This is single-arm feasibility pilot study exploring whether a combined prolonged nightly fasting (POF) and exercise program could impact hyperglycemia and other adverse metabolic consequences of PI3 kinase inhibitors in women with metastatic breast cancer (MBC).

Women who exercise regularly and who have lower levels of blood sugar and metabolic hormones like insulin have a lower risk of developing breast cancer. Some evidence also suggests that exercise and metabolism are related to cancer recurrence in women who are diagnosed with breast cancers that can be removed with surgery, but less is known about how exercise and metabolic factors are related to cancer progression in women whose cancer has advanced beyond the breast and underarm lymph nodes. This study is designed to look at the effects of exercise combined with prolonged nightly fasting (having a longer time between dinner and breakfast the next day), on blood sugar and hormones that control metabolism. This study looks to provide important information about whether making these kinds of changes is possible for women living with advanced breast cancer and will explore how making these changes effects blood sugar and hormone levels in women taking different kinds of treatments for advanced breast cancer.

The research study procedures include screening for eligibility, a baseline visit to collect information about diet and exercise habits, a baseline blood draw, participation in a 12-week diet and exercise program, and a follow up visit and blood collection at the end of the diet and exercise program.

Participants will be in this research study for up to 14-weeks, including the baseline and end of study visits to collect study measures.

It is expected that about 30 people will take part in this research study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of ER and/or PR+ metastatic or locally unresectable breast cancer
  • Postmenopausal (including concurrent use of ovarian suppression)
  • Initiating endocrine therapy in combination with:
  • Cohort 1: alpelisib
  • Cohort 2: palbociclib
  • Self-reported ability to walk two blocks
  • > 18 years of age
  • Approval from treating oncologist, confirmed via email or in writing
  • Ability to read and understand English

Exclusion criteria

  • Diagnosis of diabetes requiring medication
  • Engaging in >90 minutes of moderate or vigorous physical activity per week

Treatment and study plan

Prolonged Nightly Fasting

Behavioral

Restriction of consumption of calorie-containing food/drinks after 8pm

Exercise

Behavioral

Personalized moderate-intensity, aerobic exercise and strength training

Primary outcomes

  1. Rate of enrollment

    Time frame: 12 months

    The primary objective is to evaluate the feasibility of the intervention. Feasibility will be defined by the rate of enrollment and the intervention will be considered feasible if at least 80% of planned participants are enrolled within 12 months of study activation.

  2. Rate of adherence to prolonged overnight fasting (POF) intervention goals

    Time frame: 12 weeks

    Feasibility will additionally be defined by participants achieving POF intervention goals on 70% of days by week 12.

  3. Rate of adherence to exercise intervention goals

    Time frame: 12 weeks

    Feasibility will also be defined by at least 70% of participants achieving 120 minutes of aerobic exercise plus 2 strength training classes per week by week 12.

Secondary outcomes

  1. Changes in metabolic biomarkers between baseline and week 12

    Time frame: 12 weeks

    We will evaluate changes in fasting glucose, insulin, insulin resistance, hemoglobin A1c and other metabolic biomarkers in study participants between the baseline and end-of-intervention blood draws.

  2. Change in quality of life and patient-reported outcome measures between baseline and week 12

    Time frame: 12 weeks

    Quality of life will be evaluated for participants at baseline and at the end of the intervention using the EORTC QLQ C-30, sleep quality will be assessed via the Pittsburgh Sleep Quality Index (PSQI). Additional patient reported outcomes include the PRO-CTCAE, the 7-Day Physical Activity Recall and the 24-Hour Dietary Recall. We will assess changes in these measures between baseline and week 12 for study participants.

  3. Differences in changes in metabolic biomarkers by treatment group (palbociclib vs palbocilib)

    Time frame: 12 weeks

    We will explore potential differences in changes in metabolic markers over the course of the 12-week POF and exercise intervention by treatment group (alpelisib vs palbociclib).

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Pilot Study of the Impact of a Combined Intermittent Fasting and Exercise Intervention on Metabolic Markers in Patients With Advanced, Hormone Receptor Positive Breast Cancer

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jan 14, 2021
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.