A trial to determine the effect of glucosamine versus placebo on aromatase inhibitor induced arthralgia (joint pain) in postmenopausal women with early breast cancer who are on letrozole

Inclusion Criteria29

• Patients must be female, greater than or equal to 18 years, and be planned to commence letrozole.
• Patients must have histologically or cytologically confirmed hormone receptor positive early breast cancer in whom adjuvant treatment with letrozole is planned (initial, switch or extended situations allowed, provided no prior aromatase inhibitor had been used). Hormone receptor positivity is defined as any positivity of oestrogen and/or progesterone receptor.
• Bilateral breast cancer is allowed provided at least one of the cancers is hormone receptor positive.
• Patients with stage I, II and III disease are eligible. There must be no clinical indication of metastatic disease.
• Patients must be postmenopausal according to the following definitions:
• Prior bilateral oophorectomy;
• Aged 60 years or more and with amenorrhoea for >1year;
• If the patient has any clinical evidence of ovarian function, FSH and oestradiol levels must be assessed and be in the postmenopausal range;
• Patients who have taken HRT must have ceased HRT at least 8 weeks prior to randomisation and have biochemical (FSH and oestradiol) confirmation of postmenopausal status;
• Aged under 60 years:
• with a uterus and amenorrhoea for at least 12 months prior to trial entry
• with a uterus and amenorrhoea for less than 12 months prior to trial entry, FSH and oestradiol levels must be in the post-menopausal range
• without a uterus, FSH and oestradiol level must be in the postmenopausal range
• with a uterus and amenorrhoea following endometrial ablation or adjuvant chemotherapy. FSH and oestradiol levels must be in the postmenopausal range
• Patients
• May have received prior glucosamine (including current) provided patient is willing to withdraw her glucosamine product (by the day of randomisation) if current and to be randomised
• May have received prior adjuvant tamoxifen for up to 6 years prior to randomisation. Tamoxifen must have ceased, but not more than 6 months previously
• Must have completed adjuvant chemotherapy and radiotherapy if this has been prescribed. May be receiving trastuzumab if indicated
• Patients must have normal organ and marrow function as defined below:
• WBC >2.0x109/L
• Absolute neutrophil count >1.5x109 /L
• Platelets >100x109/L
• Total bilirubin within normal institutional limits (unless patient has Gilbert’s syndrome)
• AST/ALT 2.5 X institutional upper limit of normal
• Creatinine 1.5 X institutional upper limit of normal
• Life expectancy of greater than 2 years.
• Patients must have an ECOG performance status of 0 – 2.
• Written informed consent must be signed and dated by the patient and the investigator prior to randomisation.
• Patients must be willing and able to undergo the required assessment schedule.