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For further information, please see www.clinicaltrials.gov NCT00066573

Breast cancer sometimes recurs locally (comes back in the breast, chest or lymph nodes) despite the best initial treatment. Women with breast cancer that has recurred locally are usually treated with further surgery, radiation and/or hormone therapy. This international phase III trial will determine if adding chemotherapy to the standard treatment for a local recurrence can further improve cure rates for such women. Women who enter the trial will be randomly assigned to receive standard treatment or standard treatment plus chemotherapy. The type of chemotherapy will be chosen by the treating doctor.

Symptoms of depression, anxiety, fatigue and lack of energy are common, important and closely related in people with advanced cancer. Modern antidepressants are highly effective at relieving these symptoms in people WITH clinical depression. This study will determine if a modern antidepressant can improve these symptoms in people with advanced cancer but WITHOUT clinical depression. Patients are randomized to receive either sertraline 50mg daily or placebo. Oncological, psychological, psychiatric, social and other support services are used according to standard best practice at that centre. Participants complete quality of life booklets and are reviewed at months 0, 1, 2, 3, 4, 6, 9, and 12.

Children with cerebral palsy and other neurological impairments frequently have inadequate saliva control. The secretions may be odorous, cause chronic irritation of the facial skin and may damage clothing and books. Poor saliva control results in loss of self-esteem and can impede community inclusion. Conventional treatments include speech pathology intervention, the use of medication and surgical procedures. These interventions are not universally successful, and may be invasive (surgery) or lead to unwanted side effects (surgery and medication). There have been recent reports about the use of Botulinum toxin A (BTX-A), in the treatment of drooling. BTX-A is widely used as a treatment for spasticity in children with cerebral palsy, blocks the release of acetylcholine at the neuromuscular junction and selectively weakens the muscles for three to six months. This drug can be injected directly into the salivary glands under a general anaesthetic with ultrasound guidance. Within one to three days the drug binds on to the nerve endings and reduces the amount of saliva being produced from the injected salivary glands. Reports of the use of BTX-A are still limited with small groups of subjects, and include reports of studies in both adults and children, and also the injection of different combinations of glands in the various studies. The aim of our study is to assess the effectiveness of injections into the submandibular and parotid glands in a cohort of children with cerebral palsy and other neurological disorders. A randomised controlled study will be undertaken with children being allocated to either receive BTX-A at the start of the trial, or to a control group able to receive treatment at the conclusion of the six month study period. Measures will be undertaken at baseline for both groups, then at monthly intervals for six months. A sample size of 28 children per group will be required. Children will be recruited from the Saliva Control Clinic at the Royal Childrenÿ¿ÿ¢ÿ¿ÿ¿ÿ¿ÿ¿s Hospital and a cohort will also be recruited from the Monash Medical Centre (a separate ethics application will be made). BTX-A will then be injected into both submandibular and sublingual glands with ultrasound guidance. A short general anaesthetic will be necessary. Statistical analysis will be undertaken to determine the effectiveness of BTX-A in reducing poor saliva control. Adverse effects will be reported, and in particular, the views of parents will be established by means of a questionnaire.