Meeting News CoveragePerspective

Men’s health supplements fail to improve prostate cancer outcomes

Using men’s health supplements did not help prevent distant metastases, cancer-related death or adverse events among men undergoing definitive radiation therapy for localized prostate cancer, according to the results of a retrospective study presented at the ASTRO Annual Meeting.

“Around 50% of the patients we see are on any kind of supplement,” Nicholas G. Zaorsky, MD, resident physician in radiation oncology at Fox Chase Cancer Center, told HemOnc Today. “At least 10% are on men’s health supplements. We wanted to understand whether these supplements actually made a difference in terms of outcomes or side effects.”

The researchers defined men’s health supplements as supplements specifically labeled and marketed with the terms “men’s health” or "prostate health." These supplements are frequently labeled as having potential anticancer benefits, although no associations have been proven, according to the researchers.

Zaorsky and colleagues sought to evaluate the impact of men’s health supplements on patient outcomes and adverse events among men undergoing definitive intensity modulated radiation therapy (IMRT) for localized prostate cancer.

Study endpoints included freedom from biochemical failure, freedom from distant metastases, disease-specific survival (DSS), OS, and genitourinary and gastrointestinal toxicities.

The researchers evaluated data from 2,207 patients treated at a NCI-designated comprehensive cancer center who consented to have their information stored in a prospective database.  Men received a median IMRT dose of 78 Gy between 2001 and 2012, and 10% (n = 217) of men reported using men’s health supplements.

Median follow-up was 46 months.

Researchers performed online searches to determine the ingredients in men’s health supplements. The supplements included a median of three identifiable ingredients (range, 0-78), the most common of which was palmetto (91%). Unidentifiable ingredient names included “other,” “trade secret enzyme” and “prostate complex.”

None of the supplements evaluated had received FDA approval or had been studied in a published report.

The researchers reported that the use of men’s health supplements did not influence any outcomes. A similar proportion of men who did not and who did use supplements experienced events related to biochemical failure (9% vs. 8%), distant metastases (3% vs. 2), DSS (1% for both) and OS (9% vs. 5%).

Further, the use of men’s health supplements did not reduce the rates of grade 3 to grade 4 genitourinary (6% vs. 5%) or GI (1% vs. 0) adverse events.

“Physicians should speak to patients about all of the medications they are on, including supplements,” Zaorsky said. “Sometimes patients will not consider supplements to be medications that could affect their outcomes or side effects. We are also hoping that supplement companies will provide clear messages to their consumers. If a man is diagnosed with prostate cancer and he sees a men’s health supplement on the shelf, he might see the words ‘clinically proven’ on the bottle and think he should take it. The companies making these pills should be more transparent and not create a false message.” – by Cameron Kelsall

For more information:

Nicholas G. Zaorsky, MD, can be reached at Fox Chase Cancer Center, 333 Cottman Ave., Philadelphia, PA 19111; email: Nicholas.zaorsky@fccc.edu.

Reference:

Zaorsky NG, et al. Men’s health supplement use and outcomes among men receiving definitive intensity modulated radiation therapy for localized prostate cancer. Presented at: ASTRO Annual Meeting; Oct. 18-21, 2015; San Antonio, TX.

Disclosure: The researchers report no relevant financial disclosures.

Using men’s health supplements did not help prevent distant metastases, cancer-related death or adverse events among men undergoing definitive radiation therapy for localized prostate cancer, according to the results of a retrospective study presented at the ASTRO Annual Meeting.

“Around 50% of the patients we see are on any kind of supplement,” Nicholas G. Zaorsky, MD, resident physician in radiation oncology at Fox Chase Cancer Center, told HemOnc Today. “At least 10% are on men’s health supplements. We wanted to understand whether these supplements actually made a difference in terms of outcomes or side effects.”

The researchers defined men’s health supplements as supplements specifically labeled and marketed with the terms “men’s health” or "prostate health." These supplements are frequently labeled as having potential anticancer benefits, although no associations have been proven, according to the researchers.

Zaorsky and colleagues sought to evaluate the impact of men’s health supplements on patient outcomes and adverse events among men undergoing definitive intensity modulated radiation therapy (IMRT) for localized prostate cancer.

Study endpoints included freedom from biochemical failure, freedom from distant metastases, disease-specific survival (DSS), OS, and genitourinary and gastrointestinal toxicities.

The researchers evaluated data from 2,207 patients treated at a NCI-designated comprehensive cancer center who consented to have their information stored in a prospective database.  Men received a median IMRT dose of 78 Gy between 2001 and 2012, and 10% (n = 217) of men reported using men’s health supplements.

Median follow-up was 46 months.

Researchers performed online searches to determine the ingredients in men’s health supplements. The supplements included a median of three identifiable ingredients (range, 0-78), the most common of which was palmetto (91%). Unidentifiable ingredient names included “other,” “trade secret enzyme” and “prostate complex.”

None of the supplements evaluated had received FDA approval or had been studied in a published report.

The researchers reported that the use of men’s health supplements did not influence any outcomes. A similar proportion of men who did not and who did use supplements experienced events related to biochemical failure (9% vs. 8%), distant metastases (3% vs. 2), DSS (1% for both) and OS (9% vs. 5%).

Further, the use of men’s health supplements did not reduce the rates of grade 3 to grade 4 genitourinary (6% vs. 5%) or GI (1% vs. 0) adverse events.

“Physicians should speak to patients about all of the medications they are on, including supplements,” Zaorsky said. “Sometimes patients will not consider supplements to be medications that could affect their outcomes or side effects. We are also hoping that supplement companies will provide clear messages to their consumers. If a man is diagnosed with prostate cancer and he sees a men’s health supplement on the shelf, he might see the words ‘clinically proven’ on the bottle and think he should take it. The companies making these pills should be more transparent and not create a false message.” – by Cameron Kelsall

For more information:

Nicholas G. Zaorsky, MD, can be reached at Fox Chase Cancer Center, 333 Cottman Ave., Philadelphia, PA 19111; email: Nicholas.zaorsky@fccc.edu.

Reference:

Zaorsky NG, et al. Men’s health supplement use and outcomes among men receiving definitive intensity modulated radiation therapy for localized prostate cancer. Presented at: ASTRO Annual Meeting; Oct. 18-21, 2015; San Antonio, TX.

Disclosure: The researchers report no relevant financial disclosures.

    Perspective

    A large number of “men’s health” and “prostate health” supplements are commercially available. The new study by Zaorsky and colleagues examined whether the use of such supplements was associated with any benefit in terms of cancer control or a reduction in side effects among men undergoing radiation therapy for prostate cancer. After adjusting for other factors, there was no significant difference in the risk for biochemical progression, distant metastasis, cancer-specific mortality or overall mortality between users and nonusers. Use of these supplements also did not have a significant association with the risk for toxicity from treatment.
    Limitations of this study include a small sample size of men taking a variety of different supplements. As a result, it is not possible to rule out a benefit of one particular men’s health formulation on radiation therapy outcomes, or for men undergoing different types of prostate cancer treatment.
    Notably, other classes of supplements may have a role for patients undergoing radiation therapy, such as the use of synbiotics to reduce symptoms of radiation proctitis. However, some herbal/hormonal dietary supplements may actually cause harm. For example, Shariat and colleagues reported on two patients using the same herbal formulation for health and aging issues, who developed clinically aggressive prostate cancer.  Chemical analysis revealed the presence of testosterone and estradiol in the supplement, and the product was removed from the market after a warning from the FDA.
    Given the lack of proven benefit for most supplements, and even the potential for harm, any claims regarding utility for prostate health should be viewed with considerable skepticism. Men with prostate cancer should talk to their doctors regarding the best ways to improve their lifestyle and overall health.

    References:
    Nascimento M, et al. Int J Radiat Oncol Biol Phys. 2014;doi:10.1016/j.ijrobp.2014.05.049.
    Shariat SF, et al. Clin Cancer Res. 2008;doi:10.1158/1078-0432.CCR-07-1576.
    • Stacy Loeb, MD, MSc
    • NYU Langone Medical Center

    Disclosures: Loeb reports no relevant financial disclosures.

    Perspective
    Sumanta Kumar Pal

    Sumanta Kumar Pal

    Zaorsky and colleagues take on the controversial topic of supplement use among patients with prostate cancer in work presented at the 2015 ASTRO Annual Meeting. Specifically, in a database of 2,207 men receiving radiation treatment for localized prostate cancer, they sought to determine whether outcomes varied in the roughly 10% of the cohort that used men’s health supplements. Ultimately, no difference was found in clinical outcome — 5-year disease-specific survival (DSS) and OS were similar among users and non-users. Importantly, there were no differences in mild or severe latent toxicities among groups. 

    This work is highly relevant to the broader debate surrounding use of supplements — the debate goes well-beyond the often exorbitant costs. Recent high-profile studies have suggested that supplements may actually contribute to a higher rate of hospitalizations for a variety of indications. Within prostate cancer, large, prospective studies evaluating similar strategies (eg, vitamin E or selenium) have shown little benefit with respect to disease prevention. In advanced disease, regimens such as high-dose calcitriol, when added to chemotherapy, may actually impede survival. Considering these elements, the onus is on the investigative community to demonstrate clinical benefit from supplements — until this is achieved, use should be discouraged. 

    • Sumanta Kumar Pal, MD
    • HemOnc Today Editorial Board member City of Hope Medical Center

    Disclosures: Pal reports no relevant financial disclosures.

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