None listed
Conditions
Brief summary
Arthralgia (joint pain) and other joint related symptoms are common side effects of taking letrozole (hormone therapy). As such, some patients stop taking their hormone therapy earlier than the recommended 5 years after breast surgery. The purpose of this study is to find out if glucosamine can ease joint pain in patients taking letrozole, and therefore reduce the chance that they will stop their hormone therapy early. Participants (ER and/or PR receptor positive, postmenopausal, early breast cancer) will receive either crystalline glucosamine sulphate (1500mg tablet) or placebo that will be taken concurrently with letrozole and will be followed for a total of 24 months (maximum treatment period of 18 months followed by an off study treatment visit 6 months later). The discontinuation rate of letrozole will be determined at 12 months and 18 months. Off study treatment visit should be 24 months post-randomisation or, if discontinued study treatment prior to 18 months post-randomisation, off study visit should be 6 months post permanent cessation of CGS/placebo.
Interventions
Crystalline glucosamine sulphate is administered at 1500mg once daily over a period of 18 months. Administration of crystalline glucosamine sulphate will begin at the same time as letrozole administration. Crystalline glucosamine sulphate is administered as a single dose sachet of powder for oral solution.
Sponsors
Australia and New Zealand Breast Cancer Trials Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Patients who have received a prior aromatase inhibitor (AI). Patients receiving any other investigational agent. Patients with metastatic disease. Patients with known inflammatory arthritis that have required 3 months or more of continuous use of disease modifying agents (e.g. oral methotrexate, oral prednisone) during the 5 years prior to the date of randomisation. History of allergic reactions attributed to glucosamine, glucosamine sulphate or compounds of similar chemical or biologic composition to glucosamine sulphate. This includes shellfish. Poorly controlled diabetes. Those with well controlled diabetes may enter this study, provided diabetic control is monitored by a clinician. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant women are excluded from this study because AIs are not appropriate breast cancer treatment in these patients. Patients with previous or concomitant invasive malignancy are not eligible. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant), who are eligible if adequately treated: basal or squamous cell carcinoma of the skin in situ non-breast carcinoma without invasion contra- or ipsilateral in situ breast carcinoma non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence
Outcome results
None listed