Research Highlights

WHEL Study Results

The researchers from the Women’s Healthy Eating and Living (WHEL) study reported that women who consumed a low-fat diet rich in vegetables, fruit, and fiber after treatment for breast cancer essentially had the same risk of recurrence, incidence of new primary breast cancers, and risk of overall mortality as women who consumed diets with less servings of fruits and vegetables. The study was published in the Journal of the American Medical Association in July 2007.

The NCI-sponsored study, which followed 3,088 women with early-stage stage breast cancer over a seven-year period, was a randomized controlled trial that assigned women to either a control group or an intensive diet intervention group who were counseled to maintain a daily diet of five vegetable servings, 16 ounces of vegetable juice, 3 fruit servings, 30 grams of fiber, and 15-20 percent dietary fat. The goal was to substantially increase levels of circulating carotenoids in the blood, because previous research showed that low levels of carotenoids are associated with higher rates of breast cancer recurrence.

Earlier findings from the WHEL study, which was supported by an NCI R01 grant (Grant No. 5R01CA069375), did find that higher intake of vegetables and fruits increased the carotenoid levels in the women used in the study. “We have doubled the circulating carotenoid levels in the blood, which is much more than any other study has accomplished previously and will allow us to properly test the hypotheses,” principal investigator John P. Pierce, Ph.D., director of the Cancer Prevention and Control Program at the University of California, San Diego Cancer Center, reported back in 2006.

Interestingly, the Women’s Intervention Nutrition Study (WINS), a randomized clinical trial of 2,437 breast cancer patients who maintained a low-fat diet, reported results contrary to those of the WHEL study. The WINS results showed a reduction in the relative risk of recurrence in postmenopausal women, especially those whose cancers do not respond to estrogen (ER-negative). “These results suggest that an intervention aimed at reducing dietary fat consumption can reduce the risk of cancer recurrence,” said principal investigator Rowan T. Chlebowski, M.D., Ph.D., of the Los Angeles Biomedical Research Institute in California. “Although further confirmation is needed, a low-fat diet may offer other health benefits, such as modest weight loss.”

Dr. Sharon Ross, NCI’s program director of the WHEL study, describes the results as unfortunate and says that the next study, which would also be funded under an R01 grant, will analyze components in the women’s diets, including the specific foods that are being consumed.

“We don’t know the exact combination of fruits and vegetables that may decrease recurrence,” says Dr. Ross. “Subgroup analyses…will look at the differences in diet among the women.” In the meantime, there is no harm in increasing your vegetable intake, she adds.

“We may not know what the best diet is to prevent recurrence (in breast cancer) is,” Dr. Ross says. “But that doesn’t mean you should go have a bad diet.” There are many benefits to a healthy diet, including the prevention of heart disease, she adds.

A supplement to the study funded a survey of WHEL participants that focused on their past and current use of various CAM modalities, including mind-body practices, energy-based therapies, and alternative medical systems, such as homeopathy and naturopathy. A database tracking nutritional supplements that the women in the study took was also compiled. The results of this supplemental study are currently being analyzed and will be ready for release in 2008.

NCI CAM Studies Presented at ASCO

From June 2-5, 2007, the American Society of Clinical Oncology (ASCO) held its annual meeting in Chicago with over 30,000 participants in attendance. During the four-day conference, several NCI-sponsored CAM studies for cancer prevention and treatment were presented – an area that does not normally receive much attention at ASCO annual meetings.

A phase III clinical trial looking at the use of shark cartilage in cancer patients was one CAM study presented at the meeting.

“It’s uncommon to have phase III cancer CAM clinical trials with survival endpoints, and it’s also uncommon for CAM trials to be the subject of oral presentations instead of just posters at ASCO,” says Dr. Jeffrey White, OCCAM director. “It’s good to see this, because it raises the level of awareness for CAM research.”

The idea that shark cartilage could help treat non-small cell lung cancer was put to the test in a study led by Dr. Charles Lu from the University of Texas M.D. Anderson Cancer Center. Held at multiple sites in the U.S. and Canada, the trial accrued over 380 patients. All patients received conventional platinum-based chemotherapy with or without radiation therapy but were also randomized to receive either Neovastat, a drug containing a liquid extract of shark cartilage, or a placebo. The results of the study showed that the Neovastat did not affect survival rates for cancer patients. An earlier study had indicated that patients who took Neovastat had a decrease in the formation of new blood vessels, a process known as anti-angiogenesis. Several other drugs with anti-angiogenic effects are currently under investigation as potential anti-cancer agents.

A preliminary study involving flaxseed and its affect on prostate cancer was also presented at the meeting. This study found that men who added flaxseed to their diet had slower tumor growth rates compared to those who didn’t, suggesting flaxseed may have the potential to fight early prostate cancer.

One clinical study, funded by NCI’s Community Clinical Oncology Program, found that certain doses of American ginseng can be effective in alleviating cancer-related fatigue.

The abstracts of these NCI studies and information about the 2007 ASCO meeting can be found at www.asco.org.

Preventing Chemotherapy-Induced Neuropathy

Reprinted from the Cancer Bulletin, April 3, 2007
http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_040307/page7

Name of the Trial

Phase III Randomized Study of Alpha-Lipoic Acid in Preventing Platinum-Induced Peripheral Neuropathy in Cancer Patients Receiving a Cisplatin- or Oxaliplatin-Containing Chemotherapy Regimen (MDA-CCC-0327). See the protocol summary at http://cancer.gov/clinicaltrials/MDA-CCC-0327.

Principal Investigator

Dr. Ying Guo, University of Texas M.D. Anderson Cancer Center

Why This Trial Is Important?

Peripheral neuropathy is characterized by sensations of pain, tingling, burning, numbness, or weakness that usually begin in the hands or feet. It can be caused by certain illnesses, for example, diabetes. It can also be a side effect of treatment with platinum-based chemotherapy drugs.

Chemotherapy-induced peripheral neuropathy can be either acute or chronic. Acute peripheral neuropathy may begin during or shortly after administration of a platinum-containing drug and usually goes away on its own after several days. Chronic peripheral neuropathy may arise weeks or months after chemotherapy treatment and may be very difficult to treat; in some patients, it may be irreversible.

In this trial, researchers are testing the ability of alpha-lipoic acid to prevent peripheral neuropathy caused by the platinum-containing drugs cisplatin and oxaliplatin. Alpha-lipoic acid is an antioxidant produced naturally by the body; it can also be found in some foods and as a nutritional supplement. In diabetes patients, it has been shown to relieve symptoms of neuropathy.

"Peripheral neuropathy is a potentially disabling condition that affects many cancer patients treated with platinum-based chemotherapy," said Dr. Guo. "We hope that alpha-lipoic acid will help prevent this condition in patients being treated with cisplatin or oxaliplatin."

Patients will be randomly assigned to receive oral alpha-lipoic acid or a placebo three times a day for at least 24 weeks.

Who Can Join This Trial?

Researchers will enroll 224 patients scheduled to receive cisplatin- or oxaliplatin-based chemotherapy for cancer and who have not experienced previous peripheral neuropathy. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/MDA-CCC-0327.

Study Sites and Contact Information

Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://www.cancer.gov/clinicaltrials/MDA-CCC-0327 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.