Status:
TERMINATED
Reducing Insulin, Growth Hormones, and Tumors
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Diet Modification
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Little is known about the role of diet in the treatment of lung and other cancers, yet physicians are constantly confronted with the question 'what should I eat' by their patients. Very few randomized...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03785808
Start Date
December 21 2018
End Date
August 5 2019
Last Update
August 12 2019
Active Locations (1)
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1
Seattle Cancer Center Alliance
Seattle, Washington, United States, 98109