Nervous System Diseases

All Conditions

Peripheral Nervous System Diseases

Neuromuscular Diseases

Analgesics

Psychotropic Drugs

All Drugs and Chemicals

Vasoconstrictor Agents

Cardiotonic Agents

Duloxetine Hydrochloride

Norepinephrine

Serotonin

Serotonin and Noradrenaline Reuptake Inhibitors

Neurotransmitter Agents

Antidepressive Agents

Dopamine

Dopamine Agents

Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.

Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.

Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.

Duloxetine

Neurofeedback

Quality-of-Life Assessment

Questionnaire Administration

Sarah Prinsloo

HILARY Y. MA

This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help relieve depression and peripheral neuropathy. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity and may help teach patients with peripheral neuropathy (nerve damage) how to change their own brain waves to lower their feelings of neuropathy and help improve their overall quality of life. Giving duloxetine and neurofeedback training may work better in treating peripheral neuropathy caused by chemotherapy compared to duloxetine or neurofeedback training alone.

PRIMARY OBJECTIVE:

I. Determine if the combination of duloxetine (DL) and neurofeedback (NFB) is superior to DL or NFB alone in treating chemotherapy induced peripheral neuropathy (CIPN).

SECONDARY OBJECTIVES:

I. Determine the optimal number of neurofeedback sessions needed to result in long-term relief of CIPN in a large cohort of cancer survivors and across socioeconomic groups.

II. Examine baseline brain signatures as a predictor of response to neurofeedback (NFB) and to duloxetine and determine who will require more sessions of NFB to achieve relief of symptoms.

III. Examine if the combination of DL + NFB (than those getting DL or NFB alone) or a larger number of NFB sessions results in better improvements in cancer-related symptoms, physical functioning, and quality of life (QOL).

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients receive neurofeedback training over 1 hour each 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine orally (PO) once daily (QD) for 5 weeks in the absence of unacceptable toxicity.

GROUP II: Patients receive neurofeedback training session over 1 hour 3-5 times weekly for up to 5 weeks.

GROUP III: Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.

After completion of study, patients are followed up at 6 and 12 months.

Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy

The primary analysis will be a linear model comparing the mean difference in the change of the unpleasantness subscale of the (PQAS)Pain Quality Assessment Scale from baseline to the end of treatment (5 weeks) between the combination arm, the duloxetine (DL), and the neurofeedback (NFB) arm while adjusting for the stratification factor. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.

Will use analysis of covariance (ANCOVA) to evaluate whether chemotherapy induced peripheral neuropathy (CIPN) differs across the three subgroups with 0, 10 or 15 additional sessions of NFB, among the participants from the NFB + DL group who report at least 1-point clinical improvement in CIPN at week 5. The analysis will adjust for the baseline outcome (at week 5), time with CIPN symptoms (minimization factor), and other covariates such as age, sex, cancer stage, time since diagnosis, and cancer type, as appropriate. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.

Will perform ANCOVA with the change of the unpleasantness subscale from baseline to week 5 (i.e., end of the first 15 sessions of NFB) as the outcome, intervention (NFB, DL or combo), the brain signature (one at a time) and its interaction with intervention as the independent variables of interest. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.

Linear mixed model (LMM) analyses will be performed using data measured at end of treatment, months 6 and 12 only on patients who report clinical improvement at week 5.

ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on cancer-related symptoms.

ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on physical functioning.

ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on quality of life.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Prostatic Neoplasms

Urinary Incontinence

Enuresis

Urogenital Diseases

Male Urogenital Diseases

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Duloxetine 60mg for 3 months PMFT weekly for 3 months

Pelvic Floor Muscle Training

Rafael Sanchez-Salas, MD

Objectives:

Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.

Secondary:

* Comparison of time to achieve continence between the four arms.
* Comparison of urinary symptoms and quality of life improvement between the four arms.
* Assessment of adverse events in Duloxetine arms.

Primary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as "using no pad"or "only security pad".

Secondary outcome:

* time to achieve continence
* Quality of life tested in relation to incontinence according to Visual Analog Scale (VAS) and King's Health Questionnaire (KQH).
* Urinary symptoms measured with International Prostate Symptom Score (IPSS).

No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.

Statistical methods

* Proportion of patients who achieve continence and time to achieve continence will be compared between the four arms.
* Comparison of quality of life outcomes between the four arms
* Comparison of clinical variables that can affect the primary/secondary outcome - univariate and multivariate analysis (ITT).

Prospective RCT on Post Prostatectomy Urine Leak

A Prospective Randomized Controlled Study Comparing the Efficacy of Pelvic Floor Muscle Training and Oral Duloxetine in the Recovery of Continence After Robotic Assisted Radical Prostatectomy

Proportion of patient achieving continence at 6 months

Quality of life tested in relation to incontinence using questionnaire at 6 months

Institut Mutualiste Montsouris

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

Oxaliplatin

Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD and placebo (1 placebo capsule) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.

Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 60 mg (2 duloxetine capsules) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.

Patients in Phase II receive placebo (1 placebo capsule) orally (PO) once daily (QD) during week 1, placebo (2 placebo capsules) PO QD weeks 2-16, followed by placebo (1 placebo capsule) PO QD during week 17 in the absence of unacceptable toxicity.

Patients in Phase III receive most promising dose of duloxetine hydrochloride from Phase II PO QD in the absence of unacceptable toxicity.

Patients in Phase III receive placebo PO QD in the absence of unacceptable toxicity.

Placebo

Ellen M. Lavoie Smith, PhD

Site Public Contact

Darryl A. Outlaw

Thomas W. Butler

Alison K. Conlin

John A. Ellerton

Shahzad Siddique

Jay W. Carlson

Rangaswamy Govindarajan

Swapnil P. Rajurkar

Bogdan S. Eftimie

Henry T. Tsai

Terence W. Friedlander

Robert J. Hoyer

Alexander Menter

Christopher B. Jones

Francis K. Hall

Wylie D. Hosmer

Salvatore A. Del Prete

Gregory A. Masters

Leon C. Hwang

Anteneh A. Tesfaye

Mohamedtaki A. Tejani

Akm Mosharraf Hossain

Elie G. Dib

This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. To determine the dosage of duloxetine hydrochloride (duloxetine) (30 mg or 60 mg daily) that appears most promising in preventing oxaliplatin-induced peripheral neuropathy (OIPN). (Phase II)

II. To demonstrate that the most promising dosage of duloxetine identified in the Phase II component is more effective than placebo at preventing OIPN sensory symptoms. (Phase III)

III. To demonstrate that the most promising dosage of duloxetine identified in the Phase II component is more effective than placebo at preventing oxaliplatin-induced chronic neuropathic pain. (Phase III)

SECONDARY OBJECTIVES:

I. To characterize toxicity in each arm, including duloxetine side effects of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. (Phase II)

II. To compare the serially measured OIPN total sensory neuropathy scores calculated from the six individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) questions that quantify numbness, tingling, and pain in the fingers (or hands) and toes (or feet), measured on day 1 of each cycle of oxaliplatin treatment and at 1 month post-oxaliplatin treatment between the most promising dosage of duloxetine identified in the Phase II component and placebo. (Phase III)

III. To compare the serially measured Brief Pain Inventory Short Form (BPI-SF) patient-reported on the average pain scores, measured on day 1 of each cycle of oxaliplatin treatment and at 1 month post-oxaliplatin treatment between the most promising dosage of duloxetine identified in the Phase II component and placebo.

IV. To characterize toxicity in each arm, including duloxetine side effects of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia using the CTCAE v 5.0. (Phase III)

OUTLINE:

PHASE II: Patients are randomized to 1 of 3 arms.

ARM I: Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD and placebo (1 placebo capsule) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.

ARM II: Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 60 mg (2 duloxetine capsules) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.

ARM III: Patients in Phase II receive placebo (1 placebo capsule) orally (PO) once daily (QD) during week 1, placebo (2 placebo capsules) PO QD weeks 2-16, followed by placebo (1 placebo capsule) PO QD during week 17 in the absence of unacceptable toxicity.

PHASE III: Patients are randomized to 1 of 2 arms.

ARM I: Patients in Phase III receive most promising dose of duloxetine hydrochloride from Phase II PO QD in the absence of unacceptable toxicity.

ARM II: Patients in Phase III receive placebo PO QD in the absence of unacceptable toxicity.

NOTE: Patients in all arms receive standard of care oxaliplatin during weeks 1-12.

After completion of study, patients are followed up at 30 days and at 3, 6, 12, and 18 months after last oxaliplatin treatment.

Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer

Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study

Will be measured using 6 individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) questions that quantify numbness, tingling, and pain in the fingers (or hands) and toes (or feet). For each of the 6 individual questions, patients are asked to select 1 of 4 choices regarding how each of the sensory symptoms had affected them during the preceding week: 1 = Not at all, 2 = A little, 3 = Quite a bit, and 4 = Very much. Response will be defined as a patient reporting a highest score of ≤ 2 at any time during oxaliplatin exposure, including 1 month post-oxaliplatin treatment without discontinuing the study due to sensory oxaliplatin-induced peripheral neuropathy. The proportion of responders within each arm will be estimated by the number of responders divided by the total number of evaluable patients. Two-sided 90% exact confidence intervals for the true response proportion will be calculated according to the approach of Clopper and Pearson.

Will be measured using 6 individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) questions that quantify numbness, tingling, and pain in the distal extremities. For each of the 6 questions, patients are asked to select 1 of 4 choices regarding how each of the sensory symptoms had affected them during the preceding week: 1=Not at all, 2=A little, 3=Quite a bit, and 4=Very much. Response will be defined as a patient reporting a highest score of ≤ 2 at any time during oxaliplatin exposure, including 1 month post-oxaliplatin treatment without discontinuing the study due to sensory OIPN. The analysis population is defined as all randomized patients who received at least 1 dose of oxaliplatin and have completed the 6 QLQCIPN20 sensory symptom items on at least 1 occasion during oxaliplatin treatment, including 1 month post-oxaliplatin treatment. The Fisher exact test will be used for a between-arm comparison of the proportion of responders.

Response will be defined as a 7-day average of chronic neuropathic pain (on the average) ≤ 3 on a 0 (no pain) to 10 (pain as bad as you can imagine) scale 1 month after oxaliplatin treatment, which is obtained from the 7-day chronic neuropathy pain diary. The analysis population is defined as all randomized patients who received at least 1 dose of oxaliplatin and have completed the 7-day chronic neuropathy pain diary on at least 3 of the 7 days 1 month after the last oxaliplatin dose. The Fisher exact test will be used for a between-arm comparison of the proportion of responders.

The constellation of adverse events as scored using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 will be summarized within arms by reporting the number and percentages of patients. The proportion of each of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia using NCI CTCAE v 5.0 will be estimated within arms with the exact 90% confidence interval.

The sequence of the total sensory neuropathy scores for each patient will be measured from the Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) questionnaire, measured on day 1 of each cycle of oxaliplatin treatment and at 1 month post-oxaliplatin treatment. The corresponding area under the curve will be computed for each arm based on estimated parameters from a repeated-measures (means) mixed model and compared. The analysis population is defined as all randomized patients who received at least 1 dose of oxaliplatin and have a total sensory neuropathy score on at least 1 occasion during oxaliplatin treatment, including 1 month post-oxaliplatin treatment.

For each patient, the total sensory neuropathy score is calculated by summing the 6 individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) questions that quantify numbness, tingling, and pain in the fingers (or hands) and toes (or feet) and ranges from 1 to 24, where higher numbers indicate more severe symptoms. The sequence of the total sensory neuropathy scores for each patient will be measured on day 1 of each cycle of oxaliplatin treatment and at 1 month post-oxalipatin treatment. The corresponding area under the curve will be computed for each arm based on estimated parameters from a repeated-measures (means) mixed model and compared. The analysis population is defined as all randomized patients who received at least 1 dose of oxaliplatin and have a total sensory neuropathy score on at least 1 occasion during oxaliplatin treatment, including 1 month post-oxaliplatin treatment.

The constellation of adverse events as scored using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 will be summarized within arms by reporting the number and percentages of patients. The proportion of each of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia using NCI CTCAE v5.0 will be estimated within arms with the exact 95% confidence interval.

Alliance for Clinical Trials in Oncology

Each Patient will receive oral Duloxetine capsule 60mg at the night before operation(12hrs before surgery), the 2nd dose 60 mg Duloxetine capsule 1hr before operation and 3rd dose 60mg capsule after 24hrs postoperative

Each patient will receive a similar looking placebo capsule in the same time schedule. The placebo capsule will be prepared by hospital pharmacy to insure that active Duloxetine capsules will be indistinguishable from the placebo capsules contained starch

Placebo oral tablet

Mirna Ismail

Our aim will be to evaluate the efficacy of perioperative Duloxetine in decreasing acute postoperative pain after laparoscopic colorectal cancer surgery and its role in reducing postoperative morphine requirements

Abdominal surgery is usually associated with severe; wide spread post-operative pain. The greater propensity for pain and opioid-related side effects are likely contributing factors for poor postsurgical recovery, and it often results in significant pain and slow recovery. Although Opioids are considered the analgesics of choice to treat moderate to severe pain, their use carries the risk of side effects and hyperalgesia. Multimodal analgesia is advocated for perioperative pain management to reduce opioid use and its associated adverse effects. Multimodal analgesia can be achieved by combining different analgesics and different methods of administration, to provide better analgesia synergistically compared with conventional analgesia.Therefore, lower doses for each drug can be provided with fewer overall side-effects obtained from individual compounds.Serotonin and norepinephrine are involved in the modulation of endogenous analgesic mechanisms via descending inhibitory pain pathways in the brain and spinal cord. An increase in serotonin and norepinephrine may increase inhibition of nociceptive input and improve pain relief.

Duloxetine is a serotonin-norepinephrine reuptake inhibitor commonly prescribed for the treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions. There several reasons why duloxetine might improve postsurgical quality of recovery. First, systemic Duloxetine seems to have perioperative analgesic effects. In addition, as a serotonin-norepinephrine reuptake inhibitor, it is possible that the drug may prevent transient emotional problems that are common during the perioperative period. Lastly, the combination of less pain and better emotional status can result in better physical independence scores after surgery.

The main objective of the current study is to examine the effect of perioperative Duloxetine on postoperative pain after laparoscopic colorectal surgery.

Efficacy of Perioperative Duloxetine as a Part of Multimodal Analgesia in Laparoscopic Colorectal Cancer Surgery

total morphine consumption(mg) in 48 hours if VAS score( Visual Analog Scale ) more than 3. score from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable

- pain scores ( theVAS score ).evaluation the pain using VAS ( Visual Analog Scale ) scored from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable

- the time of first request of analgesia (morphine) requirement postoperative

Postoperative sedation will be assessed using a modified observers. Assessment of alterness /sedation scale where 6= agitated to 0 = doesn't respond to deep stimulus.

Postoperative patient satisfaction will be measured using a numerical score of 1-4 (1= poor, 2= fair, 3= good, 4= very good) .

Assiut University

principal investigator

Anticonvulsants

Central Nervous System Depressants

Channel Blockers

Gabapentin

Lacosamide

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Sodium Channel Blockers

Diuretics, Potassium Sparing

Duloxetine 30mg / day for 12 cycles (up to 6 months)

Gabapentin 300 mg / day for 12 cycles (up to 6 months)

Lacosamide 50 mg / day for 12 cycles (up to 6 months)

Sally Said, MSC

Osama Ibrahim, phd

This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.

This is a randomized, double-blind,controlled, parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer.

This study will be done on 93 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard FOLFOX-4 regimen who will divided into 3 groups:

Group 1: 31 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 12 cycles (up to 6 months).

Group 2: 31 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 12 cycles (up to 6 months).

Group 3: 31 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 12 cycles (up to 6 months).

Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients

Tanta University

Clinical Pharmacist

Skin and Connective Tissue Diseases

Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

Aromatase Inhibitors

Patients will be treated with open-label duloxetine:

* 30 mg daily x 7 days, then
* 60 mg daily x 3 weeks, then
* If a patient believes she has experienced a sufficient reduction in pain after 4 weeks of therapy, she will continue taking 60 mg daily for weeks 5-8
* If a patient does not believe she has experienced a sufficient reduction in pain after 4 weeks of therapy, she will have the option of increasing the dose to 60 mg twice daily for weeks 5-8.
* After completion of 8 weeks of therapy, patients who wish to discontinue therapy will taper off the drug over 1 week (50% decrease for 4 days, then additional 50% decrease for 3 days). Patients may continue therapy off-study at the discretion of their treating physician.

Norah L Henry, MD, PhD

Many women with breast cancer who are treated with aromatase inhibitor medications develop aches and pains during treatment, and some develop numbness and tingling in their hands and feet. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, pain medications do not work very well to relieve the pain. Duloxetine (Cymbalta) is a medication that was originally developed to treat depression. It has also been found to relieve pain that occurs in people with diabetes, fibromyalgia, arthritis, and other painful conditions. In this study we are testing to see if duloxetine will help treat the pain that can occur in women treated with aromatase inhibitors.

Aromatase inhibitor (AI) therapy is commonly used for treatment of postmenopausal women with hormone receptor-positive breast cancer. The most common toxicities are arthralgias and myalgias, which can be difficult to manage and necessitate discontinuation of therapy in up to 10% of patients. One potential interventional approach is with a pharmaceutical agent such as duloxetine, which has been shown to be effective for treatment of other types of chronic pain, including fibromyalgia and diabetic neuropathic pain.

The primary objective of this pilot study is to determine the proportion of breast cancer patients with AI-associated musculoskeletal symptoms who experience a 30% reduction in average pain score from baseline to 8 weeks due to duloxetine treatment. Participants will be treated with duloxetine for 8 weeks. Questionnaires to evaluate pain, functional status, depression, menopausal symptoms, and sleep difficulties will be administered at baseline and after 2, 4, 6, and 8 weeks of therapy. In addition, 10 milliliters blood of will be drawn from the subjects at baseline for future pharmacogenetic evaluation. If the results of this pilot study suggest that the efficacy of duloxetine therapy is greater than that expected from placebo based on historical controls, then these data will be used to design future prospective, placebo-controlled, randomized trials of treatment with duloxetine in this patient population.

Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain

UMCC 2008.62: Prospective Pilot Study Evaluating the Use of Duloxetine for Treatment of Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients

Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory \& reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.

A secondary measure is the percentage of patients treated with duloxetine who experience a sustained 30% reduction in average pain score from baseline to 8 weeks. Sustained 30% reduction is defined as at least 30% reduction in 24-hour average pain severity at the 8 week endpoint, with a 30% reduction from baseline at a visit at least 2 weeks prior to the last visit, and at least 20% reduction from baseline at every visit in between.

Eli Lilly and Company

University of Michigan Rogel Cancer Center

Assistant Professor of Internal Medicine

Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Norah L. Henry

Subjects were considered evaluable for the primary endpoint if they met all eligibility criteria and took at least one dose of duloxetine

Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.

Decrease in Average Pain With 8 Weeks of Duloxetine Therapy. (Sustained)

Overall Study

Immune System Diseases

Rare Diseases

Chronic Pain

Hypersensitivity

Neurologic Manifestations

Chronic Graft Versus Host Disease

Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.

Patient reported pain and symptoms assessment for comparison at baseline.

Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.

Lynn Henry, MD, PhD

Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy, and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety, fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain.

Pilot data suggest that duloxetine is effective in management of endocrine therapy-associated musculoskeletal pain, and a randomized placebo controlled trial of duloxetine has demonstrated efficacy for treatment of chemotherapy-induced neuropathic pain. In this mechanistic study of duloxetine, we will investigate the change in pain sensitivity with treatment in order to evaluate both why duloxetine is effective for management of pain for some patients, as well as predictors of who is likely to benefit from duloxetine. A total of 84 women with early stage breast cancer who have chronic pain following treatment, as well as 48 women who are pain free, will be enrolled. All subjects will undergo assessment of pain sensitivity and complete questionnaires. Subjects with pain will be treated with duloxetine for a total of 7 weeks, with pain sensitivity assessments before treatment and after 4 weeks of full-dose treatment.

Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy, and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety, fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain.

Data from a randomized, placebo-controlled clinical trial of duloxetine demonstrated that it is effective in management of both aromatase inhibitor-associated musculoskeletal pain and chemotherapy-induced neuropathic pain. In this mechanistic study, we investigated the change in pain sensitivity with treatment in order to evaluate both why duloxetine is effective for management of pain for some patients, as well as predictors of who is likely to benefit from duloxetine. The original protocol was designed as a randomized, placebo-controlled cross-over trial, with planned enrollment of a total of 84 women with early stage breast cancer who have chronic pain following treatment, as well as 48 women who are pain free. However because of challenges with logistics of the protocol and pain testing, the trial was redesigned after only 7 patients with pain were enrolled. The new design was a single arm trial, and all patients with pain were treated with duloxetine (no placebo); there was still a non-treatment comparator arm of patients without pain. Patients were enrolled first at the University of Michigan and then the University of Utah. A total of 39 patients with pain and 43 controls without pain were enrolled before the trial closed to enrollment. All subjects underwent assessment of pain sensitivity and completed questionnaires. Subjects with pain were treated with duloxetine for a total of 7 weeks, with pain sensitivity assessments before treatment and after 4 weeks of full-dose treatment. The data from the control patients (who did not receive any study medication) are being compared to those from the patients with pain to understand more about the differences between patients who do and do not experience treatment-related pain, and to interpret the post-intervention patient-reported and pain assessment results.

Trial was initially a randomized cross-over design. Soon after study initiation the trial design was amended because of poor accrual, and instead was a single arm open label trial in which all patients with pain were treated with study drug. Since so few patients had been enrolled at the time of study redesign, the only data analyzed were from the single treatment arm portion of the trial, and the non-intervention (baseline only) comparator.

Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain

A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients With Chronic Pain

Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.

* Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control)
* 5 weeks: Mean worst pain for all individual patients in arm 1 (intervention)
* Range of pain score 0-10 (0=no pain; 10=worst pain)

Average pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.

* Baseline: Mean average pain for all individual patients in arm 1 (intervention) and arm 2 (control)
* 5 weeks: Mean average pain for all individual patients in arm 1 (intervention)
* Range of pain score 0-10 (0=no pain; 10=worst pain)

Pain interference will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.

* Baseline: Mean pain interference for all individual patients in arm 1 (intervention)
* 5 weeks: Mean pain interference for all individual patients in arm 1 (intervention)
* Range of pain interference score 0-10 (0=no interference; 10=worst interference)

Number of sites of pain will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map.

* Baseline: Mean number of sites of pain for all individual patients in arm 1 (intervention)
* 5 weeks: Mean number of sites of pain for all individual patients in arm 1 (intervention)
* Range of number of sites of pain 0-35 (0=no pain; 35=every pre-defined body site has pain)

Fibromyalgia Symptom Severity Score will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map and Symptom Severity Scale.

* Baseline: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)
* 5 weeks: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)
* Range of Fibromyalgia Symptom Severity Score 0-12 (0=not consistent with fibromyalgia; 12=most consistent with fibromyalgia)

PainDETECT score will be assessed at baseline and 5 weeks for each individual patient using the PainDETECT questionnaire.

* Baseline: Mean PainDETECT score for all individual patients in arm 1 (intervention)
* 5 weeks: Mean PainDETECT score for all individual patients in arm 1 (intervention)
* Range of PainDETECT score -1-38 (-1=no neuropathic pain; 38=most consistent with neuropathic pain)

Neuropathy will be assessed at baseline and 5 weeks for each individual patient using the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) questionnaire.

* Baseline: Mean neuropathy score for all individual patients in arm 1 (intervention)
* 5 weeks: Mean neuropathy score for all individual patients in arm 1 (intervention)
* Range of neuropathy score 0-44 (0=no neuropathy; 44=most consistent with neuropathy)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy	NCT04560673	Chemotherapy-In... Hematopoietic a... Malignant Solid...	Duloxetine Neurofeedback Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Prospective RCT on Post Prostatectomy Urine Leak	NCT02367404	Prostate Cancer Urinary Inconti...	Duloxetine Pelvic Floor Mu...	-	Institut Mutualiste Montsouris
Prospective RCT on Post Prostatectomy Urine Leak	NCT02367404	Prostate Cancer Urinary Inconti...	Duloxetine Pelvic Floor Mu...	-	Institut Mutualiste Montsouris
Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer	NCT04137107	Stage II Colore... Stage III Color...	Oxaliplatin Duloxetine Hydr... Duloxetine Quality-of-Life... Questionnaire A... Placebo	25 Years -	Alliance for Clinical Trials in Oncology
Efficacy of Perioperative Duloxetine as a Part of Multimodal Analgesia in Laparoscopic Colorectal Cancer Surgery	NCT04294953	Colorectal Canc...	Duloxetine Placebo oral ta...	18 Years - 65 Years	Assiut University
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients	NCT05510856	Oncology	Duloxetine Gabapentin Lacosamide	18 Years -	Tanta University
Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain	NCT01028352	Breast Cancer	Duloxetine	21 Years -	University of Michigan Rogel Cancer Center
Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain	NCT01912612	Pain	Duloxetine	25 Years -	University of Michigan Rogel Cancer Center
Prospective RCT on Post Prostatectomy Urine Leak	NCT02367404	Prostate Cancer Urinary Inconti...	Duloxetine Pelvic Floor Mu...	-	Institut Mutualiste Montsouris
The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients	NCT02443194	Depression	duloxetine PLACEBO	18 Years - 80 Years	Tel-Aviv Sourasky Medical Center

Spots Global Cancer Trial Database for duloxetine

Every month we try and update this database with for duloxetine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for duloxetine

Every month we try and update this database with for duloxetine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for duloxetine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.