Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Substance Related Disorders

Musculoskeletal Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Pain

Drug-Related Side Effects and Adverse Reactions

Musculoskeletal Pain

Breast Diseases

Skin Diseases

Muscular Diseases

Neurologic Manifestations

Chemically-Induced Disorders

Quality of Life

All Drugs and Chemicals

Analgesics

Psychotropic Drugs

Natriuretic Agents

Vasoconstrictor Agents

Cardiotonic Agents

Hormones

Duloxetine Hydrochloride

Furosemide

Norepinephrine

Serotonin

Serotonin and Noradrenaline Reuptake Inhibitors

Neurotransmitter Agents

Antidepressive Agents

Dopamine

Dopamine Agents

Diuretics

Sodium Potassium Chloride Symporter Inhibitors

Standard of care (SoC) including a booklet focused on healthy behaviors

Patients randomized to the duloxetine arm will take duloxetine orally daily, with or without food, on a continuous dosing schedule.

Initial dose is 30 mg daily for 1 week, followed by 60 mg daily for a total of 6 months of treatment, followed by a taper off the medication of 30 mg daily for 1 additional week.

Duloxetine 60 MG

Patients randomized to the furosemide arm will take furosemide 40 mg orally daily, on an empty stomach with plenty of liquid, on a continuous dosing schedule.

Furosemide 40 mg

All patients will receive usual care, including a booklet focused on healthy behaviors, particularly physical exercise, to manage endocrine therapy side-effects.

Booklet for healthy behaviors

EORTC HQ

This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+/HER2- early breast cancer with joint, muscle and/or bone pain caused by the endocrine therapy.

The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and/or bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).

Patients, identified by their clinicians as suffering from Grade 2 or above endocrine therapy-related musculoskeletal symptoms \[joint/bone/muscle pain\]) for, at least, 4 weeks before enrolment will be centrally randomized 1:1:1 between:

* Control arm: Standard of care (SoC) including a booklet focused on healthy behaviors
* Experimental arm: Duloxetine 60 mg (1 pill a day) + SoC
* Experimental arm: Furosemide 40 mg (1 pill a day) + SoC

Treatment duration will be 6 months. All patients will receive usual care, including a booklet focused on healthy behaviors, particularly physical exercise, to manage endocrine therapy side-effects. Treatment administration and modifications as well as specific monitoring should be done in accordance to the SmPC of the corresponding drugs.

Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer

Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer; A Pragmatic Randomized Controlled Trial

Assessed by the Skeletal scale from the EORTC-QLQ-BR42 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means worse outcome.

Assessed by the Global Health status/Quality of Life scale from the EORTC-QLQ-C30 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means better outcome.

Assessed by the emotional functioning scale from the EORTC-QLQ-C30 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means better outcome.

Assessed by the endocrine therapy symptom scale from the EORTC-QLQ-BR42 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means worse outcome.

Proportion of patients who discontinued endocrine therapy

European Organisation for Research and Treatment of Cancer - EORTC

Delirium

Emergence Delirium

Confusion

Neurobehavioral Manifestations

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Postoperative Complications

patients received oral duloxetine 60 mg 2 hours just before operation.

patients received an identical placebo pill 2 hours just before operation.

Patients will recieve 2-hour preoperative duloxetine

Amira Hassan Ahmed, resident

This is prospective double-blinded placebo-randomized controlled trial that aims to compare the effect of preoperative administration of oral duloxetine 60 mg on decreasing the incidence of postoperative delirium in cancer patients undergoing surgery.

This is prospective double-blinded placebo-randomized controlled trial that aims to compare the effect of preoperative administration of oral duloxetine 60 mg on decreasing the incidence of postoperative delirium in cancer patients undergoing surgery.

The participating patients will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into 2 study groups . Duloxetine group (Group D): patients received oral duloxetine 60 mg 2 hours just before operation. Control group (Group C): patients received an identical placebo pill 2 hours just before operation

Interventions:

The preoperative anaesthetic assessment will be carried out including patient medical history , examination including baseline heart rate and blood pressure recording and review of patients' CBC , coagulation profile and chemistry investagations. In the operating room in all patients a large bore IV access (18 gauge) will be inserted.

All patients will be connected to standard routine monitoring ( non-invasive blood pressure , electrocardiography and peripheral oxygen saturation) . patients will undergo surgery under general anasthesia \[ induction with IV anaesthetics (propofol 2mg/kg ) , atracurium 0.5mg/kg and maintenance with inhalational anesthesia (sevoflurane and isoflurane ). patients will be transferred to ICU after surgery . CAM-ICU will be measured every eight hours (three times a day) until the patient wiil be discharged from the ICU. Positive CAM-ICU will be considered to be delirium.

Data collection:

Pre-operative data included: age, sex, ASA classification, smoking, tumor location , tumor stage, and history of medical disease. Intra-operative data included: duration of operation, blood loss, blood and fluid transfusion. Post-operative data included: length of hospital stay, and condition on discharge (living/dead).

Sample size:

Based on determining the main outcome variable, the estimated minimum required sample size is 42 patients (21 in each group).

The sample size was calculated using G\*power software 3.1.9.2., based on the following assumptions:

Main outcome variable is the variation in CAM-ICU score used to evaluate postoperative delirium in cancer surgery patients who were administered preoperative duloxetine compared to those who received a placebo. Although no prior research has examined the impact of duloxetine on delirium, one study indicated that its use resulted in a considerably better postoperative recovery outcome than that of a placebo.(Hetta et al., 2020) Main statistical test is one-sided t-test to detect the difference between the two groups, Alpha = 0.05, Power = 0.80, Effect size = 0.8, Allocation ratio= 1

Statical analysis:

Data will be analyzed using IBT SPSS advanced statistics version200(spss inc,Chicago , il) . Numerical data will be expressed as mean and standard deviation or median and range as appropriate. Qualitative data will be expressed as frequency and percentage chi-square test(fisher's exact test) will be used to examine. The relation between qualitative variables for quantitative data, comparison between two groups will be done using independent sample test or Mann Whiteny test . a P value 0.05 was considered statistically significant.

The participating patients will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into 2 study groups . Duloxetine group (Group D): patients received oral duloxetine 60 mg 2 hours just before operation. Control group (Group C): patients received an identical placebo pill 2 hours just before operation

The participating patients will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into 2 study groups .

The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery.

The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery .

Patients that will recieve preoperative duloxetine will transported to ICU .CAM-ICU will be measured every eight hours (three times a day) until the patient wiil be discharged from the ICU. Positive CAM-ICU will be considered to be delirium.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer	NCT06407401	ER+ Breast Canc... HER2-negative B... Breast Cancer S... Breast Cancer S... Breast Cancer S... Drug-Related Si... Musculoskeletal...	Duloxetine 60 M... Furosemide 40 m... Booklet for hea...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery.	NCT05949229	Post Operative ...	Duloxetine 60 M...	20 Years - 80 Years	Assiut University
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer	NCT06407401	ER+ Breast Canc... HER2-negative B... Breast Cancer S... Breast Cancer S... Breast Cancer S... Drug-Related Si... Musculoskeletal...	Duloxetine 60 M... Furosemide 40 m... Booklet for hea...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery.	NCT05949229	Post Operative ...	Duloxetine 60 M...	20 Years - 80 Years	Assiut University
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer	NCT06407401	ER+ Breast Canc... HER2-negative B... Breast Cancer S... Breast Cancer S... Breast Cancer S... Drug-Related Si... Musculoskeletal...	Duloxetine 60 M... Furosemide 40 m... Booklet for hea...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for duloxetine 60 mg