None listed
Conditions
Brief summary
Lung cancer in Australia often requires treatment with chemotherapy or targeted therapy when surgery is not possible. This study aims to find out if the addition of an antibiotic called doxycycline to targeted therapy for treatment of lung cancer can improve survival of lung cancer patients. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with metastatic lung cancer and you are already undergoing targeted therapy (with or without chemotherapy) to treat your cancer. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will be asked to take an antibiotic tablet each day for 28 days while undergoing their targeted lung cancer treatment. Participants allocated to the second group will be asked to take a placebo (sugar) tablet each day for 28 days while undergoing their targeted lung cancer treatment. Participants in both groups will then be asked to continue their scheduled lung cancer treatment and attend follow up appointments and scans as outlined by their doctor. It is hoped this research will provide more information to determine whether adding an antibiotic to chemotherapy or targeted therapy for lung cancer is able to improve survival of lung cancer patients.
Interventions
Doxycycline 100 mg tablet, 100 mg oral twice a day on the first day followed by 100 mg oral once a day for the next 27 days. Treatment period is 28 days total. Participants will receive doxycycline alongside their standard of care lung cancer treatment which will be determined prior to commencing on the study by their treating oncologist according to the local cancer treatment protocols and must include targeted therapy. Adherence to the study intervention will be monitored through the completio
Doxycycline 100 mg tablet, 100 mg oral twice a day on the first day followed by 100 mg oral once a day for the next 27 days. Treatment period is 28 days total. Participants will receive doxycycline alongside their standard of care lung cancer treatment which will be determined prior to commencing on the study by their treating oncologist according to the local cancer treatment protocols and must include targeted therapy. Adherence to the study intervention will be monitored through the completion of weekly patient diaries to record doses taken as well as final accountability of tablets returned.
Sponsors
University of Technology Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Signed informed consent Participant must be 18 years of age or over, at the time of signing the informed consent Participants who have a diagnosis of adenocarcinoma of the lung. The adenocarcinoma is metastatic. The participant has commenced targeted therapy (± chemotherapy) within the previous 7 to 35 days and is continuing on that therapy at the time of commencement of the trial medication. Willing to use (or the participant’s partner is willing to use) contraception as per local regulations for methods of contraception in people undergoing targeted anticancer therapies. A woman of childbearing potential must be willing to undergo a highly sensitive pregnancy test urine or serum (as required by local regulations) within 24 hours before the first dose of study intervention Able to complete the patient diary
Exclusion criteria
Pregnant or breastfeeding Have rapidly progressing disease during first line therapy Planned or current targeted treatment with immunotherapy. Hypersensitivity to, or inability to tolerate, doxycycline, any of the excipients of doxycycline or to any other tetracycline. Concomitant treatment with oral retinoids, including isotretinoin, etretinate and Vitamin A within the last 6 months. Regular concomitant treatment with calcium, magnesium or aluminium supplements; including antacids. Concomitant medications containing bismuth salts, or iron. Use of methoxyflurane within the last 48 hours. Concomitant use of phenobarbital (phenobarbitone), carbamazepine, or rifampicin Unable to swallow study medication. Have ALT or AST greater than or equal to 3 times or bilirubin greater than or equal to 5 times the upper limit of normal (excluding those with Gilbert’s syndrome). Severe renal impairment in the last 60 days (eGFR < 15 ml/min/1.73m2) Any other condition, which in the investigator’s opinion should preclude the participant from inclusion in the study.
Outcome results
None listed