None listed
Conditions
Brief summary
Brief description of the study purpose This study aims to find out whether the medication olanzapine can help reduce weight loss in people with head and neck cancer receiving combined chemotherapy and radiotherapy given with curative intent. Who is it for? You may be eligible for this study if you are male or female age 18 or over, with head and neck cancer who are planned to receive combined chemoradiotherapy, are able to eat by mouth, and are well enough to take part. Study details Participants in this study will take olanzapine 2.5 mg by mouth once daily for 12 weeks, starting up to two weeks before chemoradiotherapy and continuing during and after treatment. All participants receive active treatment with olanzapine in addition to their standard chemoradiotherapy; there is no randomisation. Outcomes will be compared with past patients who received standard care alone. Participants will have regular clinical assessments, including monitoring of body weight, symptoms, and routine blood tests as part of their cancer treatment. It is hoped that the results from this study will show whether olanzapine is safe and can help reduce weight loss in people with head and neck cancer receiving combined chemotherapy and radiotherapy.
Interventions
Olanzapine 2.5mg oral, daily, continually for 12 weeks. Commencing within 2 weeks prior to combined chemoradiotherapy and completing 12 weeks of olanzapine thereafter.
Adherence will be assessed with a drug diary and participants will return all unused olanzapine and empty packaging to the delegated site staff.
Sponsors
Fiona Stanley Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years at the time of enrolment. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 3. Head and neck cancer (oropharynx, hypopharynx, larynx) planned for definitive combined chemoradiotherapy. 4. Patients taking oral diet. 5. Adequate organ function. ANC > 1.0 x 109/L, platelet > 100 x 109/L, Creatinine clearance >15 ml/min, Bilirubin = 30 mg/L. 6. Ability to consent.
Exclusion criteria
1. Patients requiring adjuvant chemoradiotherapy post-surgery. 2. Patients requiring induction chemotherapy before definitive chemoradiotherapy. 3. Patients requiring insertion of invasive feeding device before chemoradiotherapy commences. 4. BMI > 30 kg/m2. 5. Intake of olanzapine for more than 3 days per week for any other indications. 6. Patients already taking any regular antipsychotic. 7. Patients with a significant mental health history that may be affected by participation in the study, clinician discretion. 8. Regular use of systemic corticosteroids (up to 4 days of dexamethasone for each cisplatin dose is permitted). 9. Pregnancy. 10. Baseline QTc greater than 480 ms. 11. Poorly controlled diabetes, HbA1c > 9.5%. 12. Allergy or intolerance to olanzapine.
Outcome results
None listed