TerminatedNot applicableNCT03785808
Official study title

Reducing Insulin, Growth Hormones, and Tumors

Study summary

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).

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedSpecial Diet Therapy (low-carb) and Special Diet Therapy (low-fat)

Plus 1 other study approaches.

Who it may be forDiet Modification · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 12, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Fred Hutchinson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Fred Hutchinson Cancer Center
Interventions being studied
Behavioral: Special Diet Therapy (low-carb); Behavioral: Special Diet Therapy (low-fat); Behavioral: Special Diet Therapy (USDA control)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Seattle Cancer Center AllianceSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 12, 2019. Always confirm current availability with the study team.

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