Clinical trial NCT04330339: Prolonged Nightly Fasting in Breast Cancer Survivors
Official title: Pilot Study to Assess Prolonged Nightly Fasting in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Breast Cancer
Survivorship
Breast Cancer Recurrent
Keywords: Fasting
Breast Cancer
Survivorship
Breast Cancer Recurrent
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Kully Family Foundation
First posted: 2020-04-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being done to examine whether fasting for 13 hours every night is feasible and if it can help breast cancer survivors lose weight and improve their health.

* Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring. Recent research suggests that prolonged nighttime fasting (\>13 hours) may improve the risk of recurrence for breast cancer.
* This study will examine if fasting for 13 hours per night is doable for participants and will also study what the effect of fasting is on quality of life, mood, fatigue, body size, and markers of health in the blood.

Detailed description: This research study involves fasting (not eating any food or drinking fluids that contain calories) for 13 hours nightly for 12 weeks.

* It is expected that about 40 people will take part in this research study.
* Eligible participants will undergo baseline assessments prior to starting the intervention.

  * Baseline assessments include measurements of weight, height, quality of life, fatigue, mood, levels of physical activity, and blood markers.
  * Assessments will be repeated at the completion of the 12-weeks

This is a a Feasibility Study, which means this is the first time that investigators are examining prolonged nightly fasting and its effect on breast cancer survivors body size, blood markers, quality of life, emotional regulation, fatigue and level of physical activity.

Eligibility criteria: Inclusion Criteria:

* Participants must have a documented history of histologically confirmed invasive breast cancer.
* Participants with a history of stage I to III invasive breast cancer, and no current evidence of disease.
* A history of bilateral breast cancer is allowed provided the patient is currently disease free, with stage I to III disease on both sides.
* No evidence of distant metastatic disease or unresectable locally recurrent disease
* All adjuvant or neoadjuvant cytotoxic chemotherapy, radiation, and surgery for breast cancer must have been completed at least 6 month prior to registration. Except:

  * Adjuvant hormonal therapy is permitted. Must have been on for a minimum of 1 month.
  * Adjuvant trastuzumab, pertuzumab, TDM1, or neratinib for Her2 positive breast cancer is permitted Age ≥18 years.
* Participant must be female.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Distant metastatic breast cancer (Stage IV breast cancer) or unresectable locally recurrent disease
* Participants with diabetes mellitus.
* Participants with a pre-existing eating disorder (anorexia nervosa, bulimia)
* Participants with a BMI\< 19kg/m2 or a weight loss of 5% in the last month or 10% in the last 3 months.
* Participants using weight loss medications at the time of study enrollment.
* Participants using oral steroids at the time of enrollment.
* Participants who are receiving any other investigational agents. Participants with uncontrolled intercurrent illness.
* Participants with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because the effects of prolonged fasting on the fetus are not known.

Primary outcomes:
measure: Percentage of Participants adhere to 13 hours of fasting
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in body mass index (BMI) (kg/m^2)
timeFrame: 12 weeks
measure: Quality of life (QOL) Change using the Functional Assessment of Cancer Therapy General Scale (FACT-G)
timeFrame: 6 and 12 weeks
measure: Change in Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety and/or depression)
timeFrame: 6 and 12 weeks
measure: Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue
timeFrame: 6 and 12 weeks
measure: Change in physical activity using the Godin Leisure-Time Exercise Questionnaire
timeFrame: 6 and 12 weeks
measure: Change in lipid profile
timeFrame: 12 weeks
measure: Change in hemoglobin A1c (%)
timeFrame: 12 weeks
measure: Change in c-reactive protein (mg/L)
timeFrame: 12 weeks
measure: Change in interleukin-6 (pg/mL)
timeFrame: 12 weeks
measure: Change in tumor necrosis factor alpha (pg/mL)
timeFrame: 12 weeks
measure: Change in insulin (mcU/mL)
timeFrame: 12 weeks
measure: Change in leptin (ng/mL)
timeFrame: 12 weeks
measure: Change in adiponectin level (microgram/mL)
timeFrame: 12 weeks
measure: Change in insulin-like growth factor (ng/mL)
timeFrame: 12 weeks
measure: Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth K O'Donnell
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Donnell E, Shapiro Y, Comander A, Isakoff S, Moy B, Spring L, Wander S, Kuter I, Shin J, Specht M, Kournioti C, Hu B, Sullivan C, Winters L, Horick N, Peppercorn J. Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). Breast Cancer Res Treat. 2022 Jun;193(3):579-587. doi: 10.1007/s10549-022-06594-4. Epub 2022 Apr 20.