Effect of Soy Phytoestrogens on Hot Flashes in Postmenopausal Women With Breast Cancer: A Randomized, Controlled Clinical Trial

Patten, Cheri L. Van

doi:10.1200/jco.20.6.1449

Cited by 153 publications

(75 citation statements)

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“…Systematic meta-analysis had shown that soy products ameliorate menopausal symptoms in post-menopausal women (19). However, BS does not reduce the hot flash symptoms in BC patients, which may relate to the short duration of usage or the placebo effect (20,21).…”

Section: Discussionmentioning

confidence: 99%

A phase II double-blinded study to evaluate the efficacy of EW02 in reducing chemotherapy-induced neutropenia in breast cancer

Liu

Huang

et al. 2015

Oncology Letters

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Abstract. EW02, a polysaccharide-enriched crude extract from black soybean, has been shown to assist hematopoiesis in chemotherapy-treated animals. The present study aimed to clarify the safety, quality of life (QOL) and efficacy for myelopoiesis of EW02 administration in early breast cancer (EBC) patients receiving adjuvant chemotherapy. A total of 60 eligible EBC patients were enrolled in a randomized, double-blinded trial, 40 of whom were prescribed 700 mg oral EW02 three times daily for 15 days in chemotherapy cycle (C)2. The remainder were prescribed a placebo. All subjects took EW02 in C3 for 15 days. Blood samples were collected at different time-points for determining the blood cell count, and the serum level of granulocyte colony-stimulating factor (G-CSF) and interleukin (IL)-6. All patients tolerated EW02 well without severe side-effects. QOL evaluation showed that only the score of one questionnaire section (QLQ-C30) was significantly increased at C1 day (D)8 to C2D8 when the EW02 and placebo groups were compared (P=0.045). No significant myelopoiesis recovery, and no incremental change in IL-6 and G-CSF levels were found in C2. Subgroup analysis showed a slightly lower decrease in absolute neutrophil count (ANC) in the EW02 patients who underwent Adriamycin + cyclophosphamide treatment compared with the placebo group. Although EW02 failed to show efficacy for myelopoiesis in the present study, EW02 was still well tolerated in EBC patients who underwent adjuvant chemotherapy.

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Section: Discussionmentioning

confidence: 99%

A phase II double-blinded study to evaluate the efficacy of EW02 in reducing chemotherapy-induced neutropenia in breast cancer

Liu

Huang

et al. 2015

Oncology Letters

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“…The Panel considers that no conclusions can be drawn from these uncontrolled studies for the scientific substantiation of the claim. Some RCTs included women with a diagnosis of breast cancer and/or on tamoxifen therapy (MacGregor et al, 2005;Nikander et al, 2003;Petri Nahas et al, 2004;Quella et al, 2000;Secreto et al, 2004;Van Patten et al, 2002). In one study, tamoxifen use was not an exclusion criterion, and the number of women recruited who were on tamoxifen (if any) was not reported (Albertazzi et al, 1998).…”

Section: 3mentioning

confidence: 99%

“…Twelve studies on soy isoflavones met the inclusion criteria (Albertazzi et al, 1998;Burke et al, 2003;Colacurci et al, 2004;Faure et al, 2002;Han et al, 2002;Knight et al, 2001;Murkies et al, 1995;Penotti et al, 2003;Scambia et al, 2000;St Germain et al, 2001;Upmalis et al, 2000;Van Patten et al, 2002). The Panel notes that study quality was not assessed in this meta-analysis and that some of the studies included did not allow conclusions to be drawn on the effects of isoflavones on the frequency of hot flushes owing to the following limitations: inclusion of women with breast cancer on tamoxifen (Van Patten et al, 2002), uncertainty as to whether women were on tamoxifen (Albertazzi et al, 1998), uncertainty as to whether subjects were blinded to the intervention (Colacurci et al, 2004), uncertainty on the amount of isoflavones provided (Murkies et al, 1995), and uncertainty as to comparability at baseline in the study groups (Scambia et al, 2000). The Panel considers that no conclusions can be drawn from these studies, and thus from the meta-analysis for the scientific substantiation of the claim.…”

Section: 3mentioning

confidence: 99%

Scientific Opinion on the substantiation of health claims related to soy isoflavones and protection of DNA, proteins and lipids from oxidative damage (ID 1286, 4245), maintenance of normal blood LDL cholesterol concentrations (ID 1135, 1704a, 3093a), reduction of vasomotor symptoms associated with menopause (ID 1654, 1704b, 2140, 3093b, 3154, 3590), maintenance of normal skin tonicity (ID 1704a), contribution to normal hair growth (ID 1704a, 4254), “cardiovascular health” (ID 3587), treatment of prostate c

2011

EFS2

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“…[55][56][57][58] The duration of supplementation investigated in these studies ranged from 9 to 12 weeks during which no severe side-effects were experienced. There was no statistical difference in menopausal symptoms between the treatment and placebo groups in all four studies.…”

Section: Emerging Phytoestrogen Supplement Marketmentioning

confidence: 99%

Do phytoestrogens reduce the risk of breast cancer and breast cancer recurrence? What clinicians need to know

Velentzis¹,

Woodside²,

Cantwell³

et al. 2008

European Journal of Cancer

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. Do phytoestrogens reduce the risk of breast cancer and breast cancer recurrence? What clinicians need to know. European journal of cancer (Oxford, England : 1990), 44(13), 1799 -1806 . DOI: 10.1016 /j.ejca.2008 Published in: European journal of cancer (Oxford, England : 1990) Queen's University Belfast -Research Portal: Link to publication record in Queen's University Belfast Research Portal General rights Copyright for the publications made accessible via the Queen's University Belfast Research Portal is retained by the author(s) and / or other copyright owners and it is a condition of accessing these publications that users recognise and abide by the legal requirements associated with these rights. In this article, we present findings from human observational and intervention studies related to both isoflavone and lignan exposure and breast cancer risk and survival. In addition, the clinical implications of these findings are examined in the light of a growing dietary supplement market. An increasing number of breast cancer patients seek to take supplements together with their standard treatment in the hope that these will either prevent recurrence or treat their menopausal symptoms. Observational studies suggest a protective effect of isoflavones on breast cancer risk and the case may be similar for increasing lignan consumption although evidence so far is inconsistent. In contrast, short-term intervention studies suggest a possible stimulatory effect on breast tissue raising concerns of possible adverse effects in breast cancer patients. However, owing to the dearth of human studies investigating effects on breast cancer recurrence and survival the role of phytoestrogens remains unclear. So far, not enough clear evidence exists on which to base guidelines for clinical use, although raising patient awareness of the uncertain effect of phytoestrogens is recommended.

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Effect of Soy Phytoestrogens on Hot Flashes in Postmenopausal Women With Breast Cancer: A Randomized, Controlled Clinical Trial

Abstract: The soy beverage did not alleviate hot flashes in women with breast cancer any more than did a placebo. Future research into other compounds is recommended to identify safe and effective therapies for hot flashes in breast cancer survivors.

Cited by 153 publications

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A phase II double-blinded study to evaluate the efficacy of EW02 in reducing chemotherapy-induced neutropenia in breast cancer

A phase II double-blinded study to evaluate the efficacy of EW02 in reducing chemotherapy-induced neutropenia in breast cancer

Do phytoestrogens reduce the risk of breast cancer and breast cancer recurrence? What clinicians need to know

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