Adrian S. Dobs, M.D., MHS
Pancreatic Cancer Patients
The specific aims of this project are:
- To evaluate the safety and efficacy of fish oils in the maintenance of body weight and lean body mass in patients with pancreatic cancer, relative to disease extent;
- To determine the extent to which the use of fish oils prevent or delay the loss of functional status and quality of life. Performance status will be assessed by the ECOG performance status (EPS) scale. Muscle strength will be documented by functional muscle tests to include the distance covered in six-minute walk, timed chair stands, timed stair climbing, and ability to perform gait exercises (tandem standing). Quality of life will be documented using standardized, cancer-specific questionnaires;
- To evaluate the mechanism of omega-3 fish oil effect on weight maintenance by documenting the anti-inflammatory, anti-oxidant and anti-catabolic/anabolic actions of omega 3 fish oils. Specifically, we will measure a) the anti-inflammatory markers: TNF-?, IL-6, IFN-?, C- reactive protein, alpha –1 antitrypsin, and alpha-1 acid glycoprotein; b) oxidative stress markers: plasma vitamin E (?-tocopherol), plasma LPO (TBARS), erythrocyte SOD activity, and leukocyte oxidative DNA damage (8-OHdG/106dG); and c) catabolic/anabolic effect: salivary cortisol profiles and gonadal hormones.
In order to achieve these specific aims, this study is currently open for enrollment of patients to conduct a developmental, three-month placebo-controlled, clinical trial in which patients with pancreatic cancer stage I through IV (resectable and unresectable) will be randomized to fish oils vs. an appearance matched oral placebo. The omega-3 fatty acids, in the form of fish oils are obtained commercially and are tested to ensure consistency in the product. Primary biological outcome variables are change in lean body mass, inflammatory and pancreatic tumor markers. Functional status and quality of life are also measured.
The specific aims of this project are:
- To evaluate the safety and efficacy of fish oils in the maintenance of body weight and lean body mass in patients with pancreatic cancer, relative to disease extent;
- To determine the extent to which the use of fish oils prevent or delay the loss of functional status and quality of life. Performance status will be assessed by the ECOG performance status (EPS) scale. Muscle strength will be documented by functional muscle tests to include the distance covered in six-minute walk, timed chair stands, timed stair climbing, and ability to perform gait exercises (tandem standing). Quality of life will be documented using standardized, cancer-specific questionnaires;
- To evaluate the mechanism of omega-3 fish oil effect on weight maintenance by documenting the anti-inflammatory, anti-oxidant and anti-catabolic/anabolic actions of omega 3 fish oils. Specifically, we will measure a) the anti-inflammatory markers: TNF-?, IL-6, IFN-?, C- reactive protein, alpha –1 antitrypsin, and alpha-1 acid glycoprotein; b) oxidative stress markers: plasma vitamin E (?-tocopherol), plasma LPO (TBARS), erythrocyte SOD activity, and leukocyte oxidative DNA damage (8-OHdG/106dG); and c) catabolic/anabolic effect: salivary cortisol profiles and gonadal hormones.
In order to achieve these specific aims, this study is currently open for enrollment of patients to conduct a developmental, three-month placebo-controlled, clinical trial in which patients with pancreatic cancer stage I through IV (resectable and unresectable) will be randomized to fish oils vs. an appearance matched oral placebo. The omega-3 fatty acids, in the form of fish oils are obtained commercially and are tested to ensure consistency in the product. Primary biological outcome variables are change in lean body mass, inflammatory and pancreatic tumor markers. Functional status and quality of life are also measured.
