Supplement found to improve quality of life for female cancer survivors

ScienceDaily (June 6, 2011) — A natural nutritional supplement, marketed for the last decade as a sexual aid, has been shown to significantly improve overall quality of life for female cancer survivors, according to researchers at Wake Forest Baptist Medical Center.

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The findings will be presented June 6 at the 2011 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

Interested in quality of life issues for female cancer survivors, Kathryn M. Greven, M.D., a radiation oncologist at Wake Forest Baptist, first learned of the supplement, called ArginMax for WomenTM, from a small study conducted at Stanford University that found that it improved sexual function. Sexual dysfunction is prevalent in female cancer survivors, so Greven set out to see if the supplement could produce the same benefit in this population. She found that, while taking the supplement did not result in any improvement in sexual function for female cancer survivors, the supplement did improve their overall quality of life.

With funding from the National Cancer Institute, researchers at the Comprehensive Cancer Center at Wake Forest Baptist, the Derrick L. Davis Forsyth Regional Cancer Center, and multiple other cancer centers across the country recruited 186 female cancer survivors to participate in the study.

To be considered, adult female volunteers had to be at least six months beyond their last active treatment for any kind of cancer, with no current evidence of cancer. Adhering to standard double-blind, placebo-controlled protocol, neither the participants nor the investigators knew who was receiving the supplement and who was receiving a placebo.

The Daily Wellness Company, based in Honolulu, Hawaii, provided materials for the study, including ArginMaxTM and placebo pills. Participants received three capsules of either ArginMaxTM or placebo twice a day for 12 weeks and were asked to complete two standardized questionnaires that accurately measure sexual function and quality of life. The questionnaires were completed at the start of the study, at four weeks, eight weeks and 12 weeks.

The Female Sexual Function Index is a questionnaire that measures different aspects of sexual function, such as desire, arousal, lubrication, orgasm, satisfaction and pain.

The FACT-G questionnaire measures overall quality of life and has been used in research of all cancer types. It evaluates physical, emotional, social and functional well-being.

ArginMaxTM was originally designed as a sexual enhancement aid, so researchers were primarily looking for improvements in sexual function in this new population. They found no benefit in this area.

However, the study findings did reveal an across-the-board boost in measures of overall quality of life for the patients who were randomized to take ArginMaxTM. The FACT-G questionnaires showed improvements in both physical and functional well being among the participants taking the supplement.

"The group taking the supplements experienced significant improvement in overall quality of life, particularly physical well-being," said Greven, the lead investigator on the study. "Bothersome symptoms such as lack of energy, pain, nausea, and sleeplessness were all improved, as were measures of functional well-being, for example the ability to perform normal activities at home or work. Simply, they reported a greater enjoyment of life, without any additional side effects from the supplement."

Edward G. Shaw, M.D., M.A., an oncologist as well as counselor, is principal investigator for Wake Forest Baptist's Community Clinical Oncology Program Research Base and a co-researcher on the study. He explained that cancer survivors can suffer from persistent inflammation, also known as chronic oxidative stress, that can continue for years following treatment of cancer causing fatigue that affects quality of life. He hypothesized that the ingredients in ArginMax for WomenTM may be helping to counteract this process.

ArginMaxTM is made from a patented formula containing a proprietary blend of L-arginine, ginseng, ginkgo, and 14 vitamins and minerals noted for boosting energy and circulation and optimizing hormonal balance. A separate Men's formula also is available.

"Beyond managing individual symptoms as they appear, the medical community has not been able to offer cancer patients more global symptom relief," he said. "This research is empowering for the community of cancer survivors. There's been some thought that dietary supplements could offer a potential benefit, but previous studies on other drugs and supplements have had disappointing outcomes. We'd like to see the results replicated in other studies, as they give us renewed hope in this area."

Greven said the findings have sparked interest among researchers about whether the supplement could improve quality of life and energy levels for other populations, as well. Future studies are being planned.

"It is very exciting that we've found something that has the potential to affect and improve quality of life for female cancer survivors," Greven said. "We still need to do further work to find an approach that will improve female sexual dysfunction."

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No tie found between PTEN and response to breast cancer drug herceptin, according to new study

ScienceDaily (June 3, 2011) — Contrary to what many oncologists had thought, a tumor suppressor protein known as PTEN does not reduce the effectiveness of the breast cancer drug herceptin, according to a study by Mayo Clinic and North Central Cancer Research Group (NCCTG) investigators.

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The study, which looked at tumors from 1,802 patients enrolled in the NCCTG N9831 clinical trial, found that patients with HER2-positive breast cancer and had either a loss of PTEN functioning or normal PTEN activity did equally well when herceptin was added to chemotherapy to prevent breast cancer recurrence.

The researchers presented their findings during the American Society of Clinical Oncology Annual Meeting in Chicago.

"This is the largest study to date evaluating PTEN's presence or loss in the context of antiHER2 therapy, and we found no connection," says the study's lead investigator, oncologist Edith Perez, M.D., director of the Breast Clinic at Mayo Clinic in Jacksonville, Fla., and the Serene M. and Frances C. Durling Professor. "Our research team is very pleased to be able to test an important question in treatment of breast cancer and arrive at a definitive answer."

The researchers stained the samples for PTEN expression and linked that data with disease-free survival. They found that PTEN status did not impact disease-free survival significantly; there was only a slightly greater benefit of adding herceptin for patients with PTEN-tumors.

Preclinical studies and some small patient studies had suggested that tumors with loss of PTEN expression would not benefit from herceptin, Dr. Perez says. As a result, investigators were considering using PTEN biomarkers in clinical studies as a test of herceptin resistance, and patients who tested positive for PTEN loss might then be offered other therapies, or invited to participate in clinical trials.

"We have all been interested in biomarkers that predict for benefit to antiHER2 therapy," Dr. Perez says, "but PTEN is not one that we should pursue further, based on our rigorous analysis."

The tumor samples examined in the study came from NCCTG N9831, a phase III randomized, multicenter clinical trial that tested adjuvant herceptin given with, or following, chemotherapy with paclitaxel, compared with chemotherapy alone.

The study was funded by the National Cancer Institute, the National Institutes of Health and Genentech. The study includes 16 co-authors; nine are from the Mayo Clinic campuses in Florida, Minnesota, and Arizona.

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Patients referred to dermatologists skin lesions evaluations also found to have other skin cancers

ScienceDaily (May 17, 2011) — Among patients referred by non-dermatologists to dermatologists for evaluation of skin lesions suspected of being malignant, only apparently one-fifth were found to be cancerous, although dermatologists identified and biopsied other incidental lesions, approximately half of which were malignant, according to a report in the May issue of Archives of Dermatology, one of the JAMA/Archives journals.

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"More than one million skin cancers are diagnosed annually in the United States , with one in five Americans developing skin cancer during their lifetime," the authors write as background information in the article. "Non-dermatologists, particularly primary care physicians, play an important role in skin lesion assessment and initiation of referrals to the dermatologist."

Kate V. Viola, M.D., of the Robert Wood Johnson Clinical Scholars Program and Yale University School of Medicine, New Haven , Conn. , and colleagues sought to evaluate the proportion of suspicious lesions identified by non-dermatologists that are found to be malignant compared to the number of secondary skin lesions identified at the time of dermatology referral.

The authors evaluated medical records of 400 patients who were referred by a non-dermatologist to the dermatology service at the Veterans Affairs (VA) Connecticut Health System for evaluation of suspicious skin lesions between January 1, 2006 and December 31, 2009.

Of the 400 patients included in the study, the average age was 77.7 years, 98 percent were white men and 74 (18.5 percent) had a history of skin cancer. Most lesions (224 of 400 or 56 percent) were considered to be non-malignant by the consulting dermatologist, requiring no biopsy. Of the 176 lesions that needed biopsies, 88 were malignant according to the dermatopathology report, meaning 88 of 400 patients (22 percent) had an index lesion (lesions that prompted the referral) that was positive for cancer.

Dermatologists biopsied an additional 111 incidental lesions (secondary lesions identified, not the reason for referral), of which 61 (55 percent) were malignant. Twelve of 61 patients (19.7 percent) with a malignant incidental lesion had an index lesion that was not biopsied. Nearly half of all skin cancers identified were not the referral lesion, and 9.8 percent of the incidental lesions discovered by the dermatologist were melanomas.

In the present study, "a substantial proportion of malignant lesions was incidentally identified by the consulting dermatologist in addition to the primary lesion of concern," the authors write. The authors also suggest that "non-dermatologists may benefit from focused educational initiatives on skin cancer detection, particularly the significance of the total body skin examination and the expectations for and limitations of teledermatology."

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