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Completed

NCT Number: NCT04330339

Prolonged Nightly Fasting in Breast Cancer Survivors

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.

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Key information

Conditions

Fasting Behavior Breast Cancer Breast Cancer Recurrent Breast Diseases Breast Neoplasms Feeding Behavior Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Survivorship

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Fasting

Behavioral

Fasting

Primary outcomes

  1. Percentage of Participants adhere to 13 hours of fasting

    Time frame: 12 weeks

    Feasibility will be demonstrated if ≥60% of participants adhere to 13 hours of fasting nightly at least 70% of the nights during the intervention.

    Adherence will be assessed through patient-reported fasting logs.

Secondary outcomes

  1. Change in body mass index (BMI) (kg/m^2)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (kg/m^2). Body mass index calculated using patient height (meters) and weight (kilograms) measured at baseline and at the completion of the study intervention. BMI = weight in kilograms divided by the square of height in meters.

  2. Quality of life (QOL) Change using the Functional Assessment of Cancer Therapy General Scale (FACT-G)

    Time frame: 6 and 12 weeks

    FACT-G is a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences)

  3. Change in Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety and/or depression)

    Time frame: 6 and 12 weeks

    Effects of prolonged nightly fasting on psychological well-being using The Hospital Anxiety and Depression Scale (HADS). Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences)

  4. Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue

    Time frame: 6 and 12 weeks

    13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Higher scores represent better functioning or less fatigue.Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences

  5. Change in physical activity using the Godin Leisure-Time Exercise Questionnaire

    Time frame: 6 and 12 weeks

    Calculated score where patient-reported weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components, as shown in the following formula:

    Weekly leisure activity score = (9 x Strenuous) + (5 x Moderate) + (3 x Light)

  6. Change in lipid profile

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). (total cholesterol: mg/dL; triglycerides: mg/dL; high-density lipoprotein cholesterol mg/dL; low-density lipoprotein cholesterol mg/dL; very low-density lipoprotein cholesterol: mg/dL; cholesterol/HDL ratio mg/dL).

  7. Change in hemoglobin A1c (%)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), hemoglobin A1c reported as percentage of average blood sugar level (mg/dL or mmol/L), higher % corresponds to higher average blood sugar levels (normal A1C level is below 5.7%)

  8. Change in c-reactive protein (mg/L)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), mg/L (hs-CRP level of 1 mg/L or lower indicates low risk of CVD, hs-CRP level of 1-3 mg/L indicates moderate risk of CVD, hs-CRP level of greater than 3 mg/L indicates high risk of CVD)

  9. Change in interleukin-6 (pg/mL)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL

  10. Change in tumor necrosis factor alpha (pg/mL)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL

  11. Change in insulin (mcU/mL)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (mcU/mL)

  12. Change in leptin (ng/mL)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL)

  13. Change in adiponectin level (microgram/mL)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (microgram/mL)

  14. Change in insulin-like growth factor (ng/mL)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL)

  15. Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population)

    Time frame: 12 weeks

    Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). Plasma glucose: mmol/L (or mg/dL), Insulin: pmol/L (or microunits/mL)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Kully Family Foundation

Registry information

Official study title

Pilot Study to Assess Prolonged Nightly Fasting in Breast Cancer Survivors

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 1, 2020
Registry last updated
Jul 21, 2022

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.

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