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Trial registered on ANZCTR


Registration number
ACTRN12611000891921
Ethics application status
Not yet submitted
Date submitted
9/08/2011
Date registered
22/08/2011
Date last updated
18/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
A multicentre, randomised, double-blind phase II study of crystalline glucosamine sulphate versus placebo in the management of aromatase inhibitor induced arthralgia in post menopausal women with early breast cancer on letrozole
Secondary ID [1] 262367 0
ANZ1101
Universal Trial Number (UTN)
Trial acronym
GALA (GlucosAmine for Letrozole induced Arthralgia)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Letrozole induced Arthralgia 268071 0
Breast cancer 270549 0
Condition category
Condition code
Cancer 268216 268216 0 0
Breast
Musculoskeletal 270707 270707 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 270708 270708 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 266760 0
Prevention
Comparator / control treatment
Placebo consisting of sodium chloride plus mannitol powder as a single dose sachet of powder for oral solution.
Control group
Placebo

Outcomes
Primary outcome [1] 268956 0
To determine the discontinuation rate of letrozole at 12 months of treatment with and without CGS.
Timepoint [1] 268956 0
12 months post randomisation
Secondary outcome [1] 276688 0
The discontinuation rate of letrozole at 18 months for letrozole induced arthralgia
Timepoint [1] 276688 0
18 months post randomisation

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
143
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA
Recruitment outside Australia
Country [1] 3626 0
New Zealand
State/province [1] 3626 0

Funding & Sponsors
Funding source category [1] 267243 0
Other Collaborative groups
Name [1] 267243 0
Australia and New Zealand Breast Cancer Trial Group
Country [1] 267243 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Breast Cancer Trials Group
Address
PO Box 155
Hunter Region Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 266308 0
None
Name [1] 266308 0
Address [1] 266308 0
Country [1] 266308 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269234 0
Ethics committee address [1] 269234 0
Ethics committee country [1] 269234 0
Date submitted for ethics approval [1] 269234 0
01/11/2011
Approval date [1] 269234 0
Ethics approval number [1] 269234 0

Summary
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.
Trial website
www.anzbctg.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32737 0
Prof John F. Forbes
Address 32737 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 32737 0
Australia
Phone 32737 0
+61 2 4925 5235
Fax 32737 0
Email 32737 0
[email protected]
Contact person for public queries
Name 15984 0
John F. Forbes
Address 15984 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 15984 0
Australia
Phone 15984 0
+61 2 4925 5235
Fax 15984 0
Email 15984 0
[email protected]
Contact person for scientific queries
Name 6912 0
John F. Forbes
Address 6912 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 6912 0
Australia
Phone 6912 0
+61 2 4925 5235
Fax 6912 0
Email 6912 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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