Research Highlights

A Low Fat Diet Wins

Results of the NCI sponsored Women's Intervention Nutrition Study (WINS) have been released showing that a reduction of dietary fat can improve breast cancer outcomes in women who are receiving conventional treatment for early-stage breast cancer. The study was published in the Journal of the National Cancer Institute in December 2006.

The study investigated 2,437 women between the ages of 48 and 79 who were being treated at 39 medical centers throughout the United States. The participants were randomized to two groups: women who ate their regular diet and women who ate a reduced-fat diet. The women at the beginning of the study ate diets averaging approximately 57 grams of fat per day. The intervention group then reduced their intake of fat by an average of 24 grams per day. Although the study design called for the control group to maintain their eating habits, this group reduced their intake of fat by 5 grams a day, an unintended outcome. After five years of maintaining the diet plans, a twenty-four percent reduction in the relative risk of recurrence for women on the low-fat diet was seen.

“In the WINS study, it took about four years to detect a reduction in risk, so clearly these are not immediate effects,” John Milner, Ph.D., chief of the Nutritional Science Research Group at NCI.

While the study suggests that decreasing the amount of fat in the diet can reduce the risk of breast cancer recurrence, more research is needed. “The relationship between dietary fat and breast cancer has been unclear,” said NCI Director John E. Niederhuber, M.D. “Certainly there is accumulating evidence that a healthy lifestyle — reduced fat consumption and exercise — is a worthy goal to decrease risk and to optimize long-term therapy outcome.”

Carnitine Supplementation for Cancer-Related Fatigue: A Clinical Trial Update

Dr. Ricardo Cruciani

Since 2001, Dr. Ricardo Cruciani, Vice Chair of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center, has been building a research program investigating carnitine supplementation for symptom management. Dr. Cruciani, who also serves as the Director of Clinical and Translational Medicine, studies carnitine as a means to manage cancer-related fatigue, one of the most common side effects of cancer and cancer treatment.

“The basis for this work stems from reports that show low levels of carnitine in patients with chronic disease including cancer,” Dr. Cruciani said. Carnitine plays an important role in cellular energy production by helping in the metabolism of long chain fatty acids, which represent a major fuel source for tissues such as the heart and skeletal muscle. Levocarnitine (L-carnitine) is a nutritional supplement that may help alleviate fatigue by increasing the level of carnitine in the body.

As principle investigator for two NIH developmental grants, Dr. Cruciani and his team conducted preliminary research which led to a Phase III trial through the Eastern Community Oncology Group (ECOG). ECOG, supported through NCI's Community Oncology and Prevention Trials Research Group (COPTRG), chose Dr. Cruciani's concept for carnitine supplementation for cancer-related fatigue as one of three studies to be “fast tracked.” OCCAM has provided three supplemental awards to ECOG in support of this trial. The initial OCCAM supplement was awarded to support the development of a symptom management consortium within ECOG. The latter two supplements were to support this first large scale L-carnitine supplementation trial using the aforementioned consortium and to support the investigation of associated biomarkers in the L-carnitine trial.

In the Phase III Randomized Study of Levocarnitine (L-carnitine) for the Management of Fatigue in Cancer Patients (ECOG-4Z02), researchers are assessing the prevalence of carnitine deficiencies in cancer patients and examining the effect of carnitine supplementation in patients experiencing moderate to severe fatigue. Patients were randomly assigned to receive either levocarnitine or a placebo. The study is now closed to accrual and has set itself apart as the largest and fastest accruing symptom management trial within the ECOG, recruiting 352 patients from multiple sites representing 17 states across the United States.

This Phase III clinical trial is a triumph on several levels for ECOG. “This CAM study is significant, because it uses a low toxicity intervention which also happens to be low tech. L-carnitine's potential as a fatigue treatment has a solid biological basis, and there are also promising clinical data in HIV patients,” said Dr. Worta McCaskill-Stevens, the clinical trial Program Director within the Division of Cancer Prevention's COPTRG.

The results of this Phase III study are currently being analyzed and will be ready for release at the end of this summer.