Metformin intervention against ovarian toxicity during chemotherapy for early breast cancer: Study protocol for a randomized double-blind placebo-controlled trial.


BACKGROUND:With the significant improvement of the cure rate and survival rate of cancer patients, the survivors face quality-of-life problems, such as a significant decline in reproductive system development, ovarian reserves and function, and even fertility loss and early menopause. These problems are often highly associated with chemotherapy-induced ovarian damage in cancer treatment. However, there are no ideal treatment strategies at present. In our attempt to develop reagents and approaches for delaying ovarian aging and protecting chemotherapy-induced ovarian injury, we recently found that metformin may be the most promising drug to protect female malignant tumor patients from chemotherapy-induced ovarian injury. This trial aims to test whether administration of metformin during chemotherapy can protect the normal ovarian function of patients with early breast cancer. METHODS:This study is prospective, randomized, double-blind and placebo-controlled. Female patients with early breast cancer (N = 314) will be randomly assigned to two groups (placebo, metformin 2000 mg). Metformin will be administered during and after chemotherapy for patients with stage I-IIIa breast cancer. The primary outcome will be the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year. Patients will be followed up for 5 years to observe long-term ovarian function and prognosis, such as overall survival (OS), objective response rate (ORR), and disease-free survival (DFS). Quality of life and safety will also be assessed. DISCUSSION:Our research will provide a new treatment strategy for fertility protection, and clinical treatment guidance for cancer patients.






Zhang J,Ma X,Li Y,Liu R,Li Y,Zhang P,Ren W,Cui P,Wang B,Zhang M,Jin Y,Li X,Wang S




Has Abstract


2020-07-01 00:00:00












  • Magnitude, symmetry and attenuation of upper body accelerations during walking in women: The role of age, fall history and walking surface.

    abstract:OBJECTIVES:The present experiment examined the role of age and fall history in upper body accelerations when walking on an even and on an uneven surface. STUDY DESIGN:An observational cross-sectional study. MAIN OUTCOME MEASURES:The magnitude (root mean square [RMS]), symmetry (harmonic ratio) and attenuation (attenu...


    pub_type: 杂志文章


    authors: Soleimanifar M,Mazaheri M,van Schooten KS,Asgari M,Mosallanezhad Z,Salavati M,Sedaghat-Nejad E,Parnianpour M

    更新日期:2020-09-01 00:00:00

  • The effects of hormone replacement therapy on plasma lipids in type II diabetes.

    abstract:OBJECTIVES:The effects of hormone replacement therapy on cardiovascular risk factors in postmenopausal women with non-insulin dependent diabetes mellitus (type II diabetes) is uncertain. METHODS:The effects of estrogen replacement therapy (ERT, conjugated equine estrogen0.625mg orally daily), combined estrogen and con...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Manwaring P,Morfis L,Diamond T,Howes LG

    更新日期:2000-03-31 00:00:00

  • The effects of a soy rich diet on serum lipids: the Menfis randomized trial.

    abstract:OBJECTIVE:To assess beneficial effects of a soy rich diet on the main biomarkers of cardiovascular health in menopause, compared with the effects of the hormone replacement therapy (HRT). METHODS:187 healthy asymptomatic postmenopausal women, aged 39-60, were recruited and randomized into three groups: a soy rich diet...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Chiechi LM,Secreto G,Vimercati A,Greco P,Venturelli E,Pansini F,Fanelli M,Loizzi P,Selvaggi L

    更新日期:2002-02-26 00:00:00

  • What's in a name? Some linguistic aspects of the climacteric.

    abstract::Examining such terms as climacteric or menopause and utilizing supportive historical data, an attempt is made to trace the development of these concepts, their time of inception and their spread. It is suggested that the persistence of popular terminology of the climacteric, especially in England, until late in the la...


    pub_type: 杂志文章


    authors: Wilbush J

    更新日期:1981-03-01 00:00:00

  • Position of the Spanish Menopause Society regarding the management of perimenopause.

    abstract::Perimenopause is an imprecise period in woman over 40 years of age, which comprises the time between the moment that the first changes in the menstrual cycle appear and the year following the definitive cessation of the menses. Besides irregular bleeding, many women also complain of hot flashes and other characteristi...


    pub_type: 杂志文章,实务指引


    authors: Mendoza N,Sánchez-Borrego R,Cancelo MJ,Calvo A,Checa MA,Cortés J,Elorriaga MA,Díaz T,González JV,Lete I,Lobo P,Martínez-Astorquiza T,Nieto A,Olalla MA,Pérez-Campos E,Porqueras R,Quereda F,Salamanca A,De La Viuda E,S

    更新日期:2013-03-01 00:00:00

  • Serum estrogen level after hormone replacement therapy and body mass index in postmenopausal and bilaterally ovariectomized women.

    abstract:OBJECTIVE:The objective of this study was to determine the relationships of serum estrogen levels after hormone replacement therapy (HRT) every other day and every day with body mass index (BMI) in postmenopausal and bilaterally ovariectomized women. METHODS:Eighty-six postmenopausal and 51 bilaterally ovariectomized ...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Yasui T,Uemura H,Umino Y,Takikawa M,Saito S,Kuwahara A,Matsuzaki T,Maegawa M,Furumoto H,Miura M,Irahara M

    更新日期:2005-01-10 00:00:00

  • Evaluating the content and development of decision aid tools for the management of menopause: A scoping review.

    abstract:OBJECTIVE:Decision-making during menopause (especially surgical menopause) can be complex given the variability in risk-benefit perceptions of menopausal treatments. Decision aid tools (DATs) help women participate in decision-making about options. Our objective is to identify and evaluate the content and development o...


    pub_type: 杂志文章,评审


    authors: Siyam T,Sultani H,Ross S,Chatterley T,Yuksel N

    更新日期:2017-12-01 00:00:00

  • Transvaginal estriol administration in postmenopausal women: a double blind comparative study of two different doses.

    abstract::A group of 72 postmenopausal women were treated for 4 weeks with vaginal suppositories containing 0.5 or 1.0 mg of estriol. The two different doses achieved an identical significant improvement of urogenital symptoms, while a dose-related effect seen to be on climacteric complaints, according to a good absorption of e...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Bottiglione F,Volpe A,Esposito G,Aloysio DD

    更新日期:1995-11-01 00:00:00

  • Validation and utility of the Attitudes to Ageing Questionnaire: Links to menopause and well-being trajectories.

    abstract:OBJECTIVES:Qualitative studies show that women link menopause to the ageing process, and yet surprisingly little research has investigated how attitudes to ageing might shape women's experience of menopause, as well as their overall well-being at midlife. This study validated the Attitudes to Ageing Questionnaire (AAQ)...


    pub_type: 杂志文章


    authors: Brown L,Bowden S,Bryant C,Brown V,Bei B,Gilson KM,Komiti A,Judd F

    更新日期:2015-10-01 00:00:00

  • Systemic therapy with estrogen or estrogen with progestin has no effect on skin collagen in postmenopausal women.

    abstract:OBJECTIVES:To investigate the effect of estrogen alone or combined with progestin on the amount and synthesis of skin collagen in postmenopausal women. METHODS:Forty-three early postmenopausal women were enrolled into this open, non-randomized parallel-groups study. Fifteen women received a continuous oral dose of 2 m...


    pub_type: 杂志文章


    authors: Haapasaari KM,Raudaskoski T,Kallioinen M,Suvanto-Luukkonen E,Kauppila A,Läärä E,Risteli J,Oikarinen A

    更新日期:1997-06-01 00:00:00

  • Methamphetamine and its immune-modulating effects.

    abstract::The recreational use of methamphetamine (METH, or ice) is a global burden. It pervades and plagues contemporary society; it has been estimated that there are up to 35 million users worldwide. METH is a highly addictive psychotropic compound which acts on the central nervous system, and chronic use can induce psychotic...


    pub_type: 杂志文章,评审


    authors: Papageorgiou M,Raza A,Fraser S,Nurgali K,Apostolopoulos V

    更新日期:2019-03-01 00:00:00

  • A systematic review of social support interventions for caregivers of people with dementia: Are they doing what they promise?

    abstract:OBJECTIVE:Social support interventions for caregivers of persons with dementia (PwD) are important because informal carers often rely on their social networks for support. This systematic review synthesises findings from research on social support interventions, and examines their methodological quality and effectivene...


    pub_type: 杂志文章,评审


    authors: Dam AE,de Vugt ME,Klinkenberg IP,Verhey FR,van Boxtel MP

    更新日期:2016-03-01 00:00:00

  • Defining menopausal status in epidemiologic studies: A comparison of multiple approaches and their effects on breast cancer rates.

    abstract:OBJECTIVES:Menopausal status is a common covariate in epidemiologic studies. Still, there are no standard definitions for menopausal status using observational data. This study assesses distinctions between menopausal status definitions using commonly collected epidemiologic data, and explores their impact on study out...


    pub_type: 杂志文章


    authors: Phipps AI,Ichikawa L,Bowles EJ,Carney PA,Kerlikowske K,Miglioretti DL,Buist DS

    更新日期:2010-09-01 00:00:00

  • Adverse drug reactions in elderly patients with cognitive disorders: A systematic review.

    abstract::Elderly subjects with cognitive disorders are at particularly high risk of adverse drug reactions (ADRs). The objectives of our systematic review were to describe the prevalence of ADRs in elderly patients with cognitive disorders, the different types of ADRs and the medications suspected of involvement; to describe w...


    pub_type: 杂志文章,评审


    authors: Kanagaratnam L,Dramé M,Trenque T,Oubaya N,Nazeyrollas P,Novella JL,Jolly D,Mahmoudi R

    更新日期:2016-03-01 00:00:00

  • Parsing the ageing Asian woman: symptom results from the China study of midlife women.

    abstract:OBJECTIVES:It has become popular to assert that Asian women in general have low midlife rates of reporting a wide variety of symptoms and that these rates are much lower than those found among women in western countries. Comparable data from mainland China remains sparse, however. This study aimed to uncover the sympto...


    pub_type: 杂志文章


    authors: Shea JL

    更新日期:2006-08-20 00:00:00

  • Long-term compliance of continuous combined estrogen and progestogen replacement in postmenopausal women.

    abstract::The occurrence of uterine bleeding usually associated with hormonal replacement therapy is not acceptable for many women. Our objective was to review data on compliance and bleeding patterns in 70 postmenopausal women on oral replacement with estradiol 2 mg, estriol 1 mg, and norethisterone acetate 1 mg daily administ...


    pub_type: 杂志文章


    authors: Dören M,Schneider HP

    更新日期:1996-10-01 00:00:00

  • Endometrial thickness assessed by transvaginal ultrasound insufficiently predicts occurrence of hyperplasia during unopposed oestrogen use.

    abstract::In the present study, unopposed oestrogens were given to 184 non-hysterectomized women, for a duration varying from four weeks to 24 months, while the endometrial responses were monitored by transvaginal sonography (TVS) and backed up by endometrial sampling (conducted when the endometrial thickness reached 8 mm (doub...


    pub_type: 杂志文章


    authors: Meuwissen JH,Oddens BJ,Klinkhamer PJ

    更新日期:1996-05-01 00:00:00

  • Menopausal hormone therapy use in relation to breast cancer incidence in 11 European countries.

    abstract:INTRODUCTION:The use of menopausal hormone therapy (MHT) has decreased in many countries in the past 10 years. This is a consequence of the initial publication of the results of the Women's Health Initiative (WHI) randomized trial of estrogen plus progestin. In various countries, further studies then analyzed the incid...


    pub_type: 杂志文章


    authors: Antoine C,Ameye L,Paesmans M,de Azambuja E,Rozenberg S

    更新日期:2016-02-01 00:00:00

  • Exercise and type 2 diabetes: new prescription for an old problem.

    abstract::During the past 50 years, the prevalence of a cluster of chronic, inactivity-related diseases including obesity, insulin resistance and type 2 diabetes mellitus (T2DM), collectively referred to as 'metabolic syndrome' (MetS) has reached global epidemic proportions. Appropriate exercise training is a clinically proven,...


    pub_type: 杂志文章,评审


    authors: Bird SR,Hawley JA

    更新日期:2012-08-01 00:00:00

  • Dose proportionality study of four doses of an estradiol transdermal system, Estradot.

    abstract:OBJECTIVES:To establish dose proportionality among four doses of a new estradiol transdermal system (ETS), Estradot, in healthy postmenopausal women and to evaluate the wear and irritation properties of the ETS. METHODS:In an open label, single-dose, randomized, four-period crossover study, healthy postmenopausal wome...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Hossain M,Quebe-Fehling E,Sergejew T,Schmidt G,Skerjanec A,Ibarra de Palacios P,Krinsky L

    更新日期:2003-11-20 00:00:00

  • Soy for the treatment of perimenopausal symptoms--a systematic review.

    abstract:OBJECTIVES:Many women have turned to complementary and alternative medicines for relief from their perimenopausal symptoms. The prevalence of plant-based medicine use among perimenopausal women highlights the need for investigation into these interventions. The aim of this study was to evaluate the benefit of soy prepa...


    pub_type: 杂志文章,评审


    authors: Huntley AL,Ernst E

    更新日期:2004-01-20 00:00:00

  • Compliance with long-term oral hormonal replacement therapy.

    abstract:OBJECTIVE:To study long-term compliance with oral hormonal replacement therapy (HRT). METHODS:A total of 151 early postmenopausal women were initially randomly allocated to three groups in a double-blind, placebo controlled trial. Fifty women received continuous combined therapy, another 50 were placed on sequential t...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Eiken P,Kolthoff N

    更新日期:1995-09-01 00:00:00

  • Monitoring of oestrogen replacement therapy by vaginosonography of the endometrium.

    abstract::To prevent hyperplasia and carcinoma of the endometrium during oestrogen replacement therapy (ORT), the addition of progestogens once a month is considered mandatory. However, there is no sound scientific basis for this assumption. As the addition of progestogens has several disadvantages, it is important to minimize ...


    pub_type: 杂志文章


    authors: Meuwissen JH,van Langen H,Moret E,Navarro-Morquecho I

    更新日期:1992-08-01 00:00:00

  • Does apolipoprotein E genotype relate to BMD and bone markers in postmenopausal women?

    abstract:OBJECTIVES:Bone mineral density (BMD) and development of osteoporosis are partly determined by genetic factors. The associations between one of suggested candidate, apolipoprotein E (apo E) genotype to bone mineral density (BMD) and bone biochemical markers was studied in 464 subjects recruited from a population-based ...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Heikkinen AM,Kröger H,Niskanen L,Komulainen MH,Ryynänen M,Parviainen MT,Tuppurainen MT,Honkanen R,Saarikoski S

    更新日期:2000-01-15 00:00:00

  • The role of stress and self-efficacy in somatic and psychological symptoms during the climacteric period - Is there a specific association?

    abstract:OBJECTIVES:To investigate the influence and specificity of sociodemographic and psychological factors on the perception of symptoms associated with menopause. STUDY DESIGN:Data are based on a nationwide cross-sectional survey study in Germany. A representative sample of 1350 females aged 14-95 years was examined. Soci...


    pub_type: 杂志文章


    authors: Weidner K,Bittner A,Beutel M,Goeckenjan M,Brähler E,Garthus-Niegel S

    更新日期:2020-06-01 00:00:00

  • Comparison of a transdermal continuous combined and an interrupted progestogen HRT.

    abstract:OBJECTIVES:Pilot study to compare the effects of a continuous combined hormone replacement therapy (HRT) regimen with an interrupted progestogen regimen administered transdermally, upon the endometrium of postmenopausal women, the incidence of amenorrhoea and relief of menopausal symptoms. METHODS:Fifty-nine postmenop...


    pub_type: 杂志文章,随机对照试验


    authors: Cameron ST,Glasier AF,Gebbie A,Dewart H,Baird DT

    更新日期:2006-01-10 00:00:00

  • In utero exposure to carcinogens: Epigenetics, developmental disruption and consequences in later life.

    abstract::The uterine environment is often viewed as a relatively safe haven, being guarded by the placenta which acts as a filter, permitting required materials to enter and unwanted products to be removed. However, this defensive barrier is sometimes breached by potential chemical hazards to which the mother may be subjected....


    pub_type: 杂志文章,评审


    authors: Waring RH,Harris RM,Mitchell SC

    更新日期:2016-04-01 00:00:00

  • Prevention of postmenopausal bone loss with minimal uterine bleeding using low dose continuous estrogen/progestin therapy: a 2-year prospective study.

    abstract:OBJECTIVE:To re-examine the minimal effective dose of conjugated estrogen (CEE)-progestin hormone replacement on postmenopausal bone loss. DESIGN:A 2-year, prospective, open label, randomized study. SETTING:Department of Obstetrics and Gynecology of a university hospital. PARTICIPANTS:Fifty-two postmenopausal or oop...


    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Mizunuma H,Okano H,Soda M,Kagami I,Miyamoto S,Tokizawa T,Honjo S,Ibuki Y

    更新日期:1997-05-01 00:00:00

  • Metabolic syndrome after menopause and the role of hormones.

    abstract:OBJECTIVES:The purpose of this review is to focus on the importance of metabolic syndrome (MBS) and its increased prevalence in postmenopausal (PM) women. Also the role of hormonal therapy in PM women with MBS will be discussed. METHODS:Review of the relevant literature and results from recent clinical trials. RESULT...


    pub_type: 杂志文章,评审


    authors: Lobo RA

    更新日期:2008-05-20 00:00:00

  • Facial wrinkling in postmenopausal women. Effects of smoking status and hormone replacement therapy.

    abstract:BACKGROUND:There is some evidence that hormone replacement therapy may produce significant improvements in fine wrinkling, while aging skin is more frequently found in smokers. However, studies of the combined effect of a protective factor, such as HRT, and a damaging factor, such as smoking, are rare. OBJECTIVES:To d...


    pub_type: 临床试验,杂志文章


    authors: Castelo-Branco C,Figueras F,Martínez de Osaba MJ,Vanrell JA

    更新日期:1998-05-20 00:00:00