Effect of Meal Timing During Adjuvant Treatment for Cancer
Recruiting
N/AInterventional Study
Cancer
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
Treatment
Participants needed
50 (estimated)
Sponsor
Fred Hutchinson Cancer Center · Other
Who this trial is looking for
This trial is looking for adults with a specific type of cancer who have had surgery and are starting additional treatment. Participants will follow a meal timing plan to see if it helps improve their treatment outcomes and health.
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 solid tumor that has been surgically removed and am starting further treatment.
I have a body mass index (BMI) of at least 18.5.
I am willing to follow the study requirements.
You may not be able to join if
I do not plan to have any additional treatment after surgery.
I usually eat within a 10-hour window most days.
I work night shifts regularly.
I need nutrition through a feeding tube.
I am pregnant or breastfeeding.
I have a second cancer that needs treatment.
I have serious mental health or social issues that would affect my participation.
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 a few quick questions to see if you may meet the eligibility requirements.
The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response, patient well-being and long-term metabolic health. In alignment with these priorities, we propose to focus on patients with histologically or cytologically confirmed solid tumors treated with curative-intent surgical resection and planne…
The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response, patient well-being and long-term metabolic health. In alignment with these priorities, we propose to focus on patients with histologically or cytologically confirmed solid tumors treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care).
A promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years (no upper age limit)
* Any sex or gender
* Histologically or cytologically confirmed solid tumor treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation p…
Inclusion Criteria:
* Age ≥18 years (no upper age limit)
* Any sex or gender
* Histologically or cytologically confirmed solid tumor treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care)
* BMI ≥18.5 kg/m2
* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
Exclusion Criteria:
* No plan for systemic adjuvant therapy after surgery
* Strictly adhering to a \<10-hour eating window on most days
* Regular overnight shift work (≥1 night shift per week)
* Dependent on parenteral or enteral nutrition
* Pregnant or breastfeeding
* Active second malignancy requiring systemic therapy (exceptions: non-melanoma skin cancers or in situ cervical cancers adequately treated)
* Severe psychiatric, cognitive, or social conditions that would interfere with adherence to study procedures
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