Prolonged Nightly Fasting in Breast Cancer Survivors

NCT04330339 | Completed

• 1 other identifier: 19-586
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasting; Breast Cancer; Survivorship; Breast Cancer Recurrent

Keywords

Fasting; Breast Cancer; Survivorship; Breast Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants adhere to 13 hours of fasting

  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.

  12 weeks

Secondary Outcomes (15)

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

  12 weeks

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

  6 and 12 weeks

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

  6 and 12 weeks

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

  6 and 12 weeks

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

  6 and 12 weeks

Study Arms (1)

Fasting

EXPERIMENTAL

* 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. * Participants will fast for 13 hours nightly for 12 weeks. * Assessments will be repeated at the completion of the 12-week intervention.

Behavioral: Fasting

Interventions

Fasting BEHAVIORAL

Fasting

Fasting

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Kully Family Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 35441995 RESULT

MeSH Terms

Conditions

Fasting; Breast Neoplasms

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth K O'Donnell

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 1, 2020
• Study Start: July 24, 2020
• Primary Completion: January 31, 2021
• Study Completion: July 5, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)