Reducing Insulin, Growth Hormones, and Tumors

Stopped early · Not applicable · Has a placebo group

Conditions studied: Diet Modification, Lung Cancer

In brief

The objective of this project is to compare the effect of two widely implemented cancer diets, differing drastically in macronutrient content, on biomarkers of inflammation, compared to a control diet. Diet A will be a low-carbohydrate, high-fat ketogenic-type diet with an emphasis on whole foods. By limiting carbohydrate, the diet will have an extremely low glycemic load, thereby minimizing diurnal glucose and insulin excursions. Diet B will be a low-fat, high-carbohydrate whole foods plant-based diet. It will include only fiber-rich, low-glycemic index sources of carbohydrates and largely eliminate animal protein, which will minimize rapid spikes in blood glucose and insulin and the production of IGF-1. This diet is also hypothesized to improve glucose tolerance and insulin sensitivity, which should further help minimize diurnal glycemic and insulinemic excursions. Both diets will be compared to a control diet based on the 2015 USDA Dietary Guidelines for Americans (Diet C) in patients suffering from advanced lung cancer as they are completing medical therapy. The overarching hypothesis motivating this work is that a nutrient dense diet that minimizes known factors involved in tumor growth and progression may improve the effectiveness of therapy. Our specific hypothesis is that participants following either of the experimental diets, A or B, will experience a reduction in biomarkers of insulin resistance and chronic inflammation, both of which are known risk factors for progression in lung cancer, and a greater median time to progression compared to those on the control diet (Diet C).

Key facts

Study ID: NCT03785808
Run by: Fred Hutchinson Cancer Center
People needed: 3
Starts: 2018-12-21
Expected to finish: 2019-08-05
Last updated by the study team: 2019-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults (18 years or older) receiving treatment at the Seattle Cancer Care Alliance (SCCA)
Stage IIIB and IV non-small cell adenocarcinoma or squamous cell carcinoma, or small cell lung cancer with advanced disease receiving therapy with systemic treatment
Body mass index (BMI) >= 20 kg/m\^2
Body weight within 10% of current weight within the 3 months before starting the study
Able and willing to attend bi-weekly dietary support sessions at the Seattle Cancer Care Alliance (SCCA) during the initial 12-week intervention period
Willing and able to follow the dietary regimen
Willing to maintain usual lifestyle habits (other than diet) throughout the study (e.g., physical activity habits)
Ability to understand, speak, and write in English
Ability to provide informed written consent

You may not qualify if…

Neuroendocrine large cell carcinoma or atypical carcinoids with metastatic disease
Small cell lung cancer receiving curative therapy with radiation
Use of antidiabetic medications or insulin within the last 6 months
Presence of grade 2 weight loss, cachexia, and/or severe nausea
Current participation in therapeutic first line trial
Alcohol intake > 2 drinks per day
Major dietary restriction, as determined by the researcher
Other significant health condition as determined by the researcher

Where it is running

Seattle Cancer Center Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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