No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
55 (estimated)
Sponsor
Thomas Jefferson University · Other
Who this trial is looking for
This trial is looking for adults with early-stage breast cancer who are starting chemotherapy. Taking part involves following a specific eating schedule for 16 weeks while undergoing treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have a body mass index (BMI) between 25 and 40.
I have been diagnosed with invasive breast cancer.
My cancer is at stage I-III.
I am willing to follow the eating schedule for 16 weeks.
I have good health to start chemotherapy.
I can communicate in English.
I have an email address and can check it daily.
You may not be able to join if
I have clinical T4 or N3 disease.
I have had any prior treatment for my current breast cancer.
I am pregnant or breastfeeding.
I have type 1 diabetes or type 2 diabetes treated with insulin.
I have a history of eating disorders.
I work on a rotating shift schedule.
I have impaired decision-making capacity.
I started my chemotherapy more than 2 weeks ago.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This phase II trial studies whether time restricted eating (TRE) works to improve outcomes in patients with stage I-III breast cancer receiving chemotherapy before surgery (neoadjuvant) with a body mass index (BMI) 25-40. TRE has been shown to elicit similar metabolic changes as calorie restriction such as reduction in blood glucose levels, improved insulin sensitivity, and reduction of tumor cell…
This phase II trial studies whether time restricted eating (TRE) works to improve outcomes in patients with stage I-III breast cancer receiving chemotherapy before surgery (neoadjuvant) with a body mass index (BMI) 25-40. TRE has been shown to elicit similar metabolic changes as calorie restriction such as reduction in blood glucose levels, improved insulin sensitivity, and reduction of tumor cell growth. TRE may improve outcomes in patients with breast cancer.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
INCLUSION CRITERIA:
* Patient must be \>= 18 years of age at time of consent and must be able to understand and provide informed consent
* BMI 25-40 at time of enrollment
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient must have a recent diag…
INCLUSION CRITERIA:
* Patient must be \>= 18 years of age at time of consent and must be able to understand and provide informed consent
* BMI 25-40 at time of enrollment
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma
\* Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy
* Patients must have clinical stage I-III (utilizing tumor, node, metastasis \[TNM\] criterion) at diagnosis
* Clinical T size must be \>= 1.5 cm if there is no radiographic or clinical evidence of axillary lymph node involvement. Any size tumor is allowed if axillary lymph nodes appear to be involved
* Patient must be willing and able (have no contraindication) to receive recommended standard neoadjuvant therapy consisting of at least 16 weeks of planned neoadjuvant chemotherapy
* Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician
* Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks
* Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 6 months after the last study intervention
* Patient must have a personal email address, an internet-capable device, and the ability/ willingness to read and reply to email every day for the duration of the study
EXCLUSION CRITERIA:
* Clinical T4 and/or N3 disease, including inflammatory breast cancer
* Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy
* Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention
* Patients with type 1 diabetes, or type 2 diabetes treated with insulin
* Patients with a history of eating disorder
* Patients who work on a rotating shift schedule
* Patients must not have impaired decision-making capacity
* Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool
* Patients that are \> 2 weeks into starting neoadjuvant chemotherapy regimen
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.