Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-99
SponsorUniversity of Illinois at Chicago

About this trial

This study is being done to better understand how time restricted eating (eating all food in an 8 hour window) can help a person receiving chemotherapy treatment for breast cancer, stages I-IV. The aim is to find out if time restricted is feasible and acceptable to individuals starting chemotherapy for breast cancer. We will test 3 different eating window options compared to a control group for 24 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 25-99 at time of consent

English language or Spanish language (based on availability of lab interpreters)

ECOG 0 or 1

Breast cancer to meet histologically confirmed Stage I-III or Stage IV with Medical Oncology approval.

Disqualifiers

Women with type 1 or insulin dependent type 2 diabetes

Women with BMI > 45kg/m2 and < 18.5 kg/m2

Women who are pregnant or nursing. A negative serum or urine pregnancy test is required per institutional practice guidelines.

Shift workers

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time restricted eating

    Behavioral

    Participants assigned to this arm will follow the 8-h TRE protocol. Participants will consume food ad libitum (no calorie or food restrictions) during a self-selected 8-h eating window (beginning at 10:00 am, 11:00am, or 12:00 pm) and fasting for 16 hours daily. They will follow this same eating pattern for the length of the intervention. Calorie free drinks such as water, black coffee, and diet soda, are permitted during the fasting period. The eating window will allow for a typical breakfast/lunch/dinner eating pattern.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Standard Care controlNo intervention 0 interventions
Group B: 8-h TREExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment feasibility

women eligible and referred by staff to the research team. We will also track the number of referred women approached (by phone \& in person) by our research team for screening/enrollment and the number of women who decline and their reasons for non-enrollment

Time frame
24 weeks
2

TRE Acceptibility

attendance at study visits, completeness of data, and overall and treatment specific loss to follow-up/withdrawal will be closely monitored

Time frame
24 weeks
3

TRE adherence

Diet adherence will be monitored either by patient reported start and stop times of food intake and diet pattern scoring and will be assessed by the study coordinator with a total score of 7 days per week followed by a post intervention qualitative survey.

Time frame
24 weeks

Secondary outcomes

1

Quality of Life

European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire

Time frame
24 weeks
2

Fatigue

The Functional assessment of Cancer therapy - fatigue

Time frame
24 weeks
3

Treatment related side effects

Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, PRO-CTCAE

Time frame
24 weeks
4

Biochmical blood count Safety

CBC

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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