Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Pain, Postoperative

Breast Neoplasms

Pain

Postoperative Complications

Neurologic Manifestations

Pharmaceutical Solutions

All Drugs and Chemicals

Analgesics

Central Nervous System Depressants

Antitussive Agents

Narcotic Antagonists

Respiratory System Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics, Opioid

Butorphanol

Tramadol

Anti-Inflammatory Agents, Non-Steroidal

Flurbiprofen

Flurbiprofen axetil

Narcotics

Analgesics, Non-Narcotic

Butorphanol tartrate 1mg was given intravenously.

Butorphanol tartrate 2 mg was given intravenously.

Flurbiprofen Axetil 50 mg was given intravenously.

Flurbiprofen Axetil 100 mg was given intravenously.

Tramadol Hydrochloride 10 mg was given intravenously.

Tramadol Hydrochloride 20 mg was given intravenously.

Saline

Opioid

NSAID

XiaoFeng Shen, MD

With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.

Comparison of Pain Therapeutic Effects After Benign Mastectomy

Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Nanjing Medical University

XiaoFeng Shen

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Ibuprofen

Patients undergoing elective colorectal cancer resection before april 1st 2016 were treated with paracetamol tablets 1000 mg and ibuprofen tablets 400 mg four times a day from the day of the operation and until discharge.

Patients undergoing elective colorectal cancer resection from april 1st 2016 were only treated with paracetamol tablets 1000 mg four times a day from the day of the operation and until discharge.

no other intervention than described in the groups.

Ismail Gögenur, Med.Sc.D

Patients undergoing an operation for colorectal cancer are normally treated with non-steroid-anti-inflammatory-drugs (NSAIDs) e.g. ibuprofen as pain medication after the operation. It is well known that NSAIDs can be harmful to kidney-and heart patients and some studies also have shown an increased risc of surgical complications after treatment with NSAIDs. On the other hand recent studies have found a preventive effect of NSAIDs on colorectal cancer recurrence thus leaving the colorectal surgeon in doubt whether NSAIDs are beneficial or harmful to colorectal cancer patients.

In the department of colorectal cancer surgery at Zealand University Hospital it was decided to leave out NSAIDs from the 1st of april 2016. This study will investigate if there is a change in consumption of opioids before and after omission of NSAIDs. This will be an important finding because opioids also have harmful side-effects as well as a risk of addiction. The investigators will also compare the blood samples and see if there is signs of impaired renal and cardiac function in the group that was treated with NSAIDs. Finally the long term outcomes will be investigated such as cancer recurrence and death in the two groups.

Background:

Many standard analgesic regimens after colorectal cancer surgery includes a NSAID in combination with paracetamol and other non-opioid analgesics. Concerns about a risk of cardiovascular and renal impairment and the possible association with anastomotic leaks have questioned the rationale of NSAID use in the postoperative period and the need for possible alternatives. In the department of colorectal cancer -surgery of Zealand University Hospital it was decided to remove NSAIDs from the standard analgesic package from 1th of April 2016 without other analgesic substitution. This change might imply deterioration of the enhanced recovery program with an increase in the use of opioids and side effects that might cause a longer length of stay. In addition, recent studies are relaunching ibuprofen as a chemo-preventive of colorectal cancer thus leaving the colorectal surgeon in doubt whether NSAIDs are beneficial or harmful to colorectal cancer patients.

Objective:

The aim of the present study is to investigate the short- and long-term outcomes before (+ ibuprofen) and after (- ibuprofen) April 1 st 2016.

Methods Design A prospective, consecutive single-center cohort-study. Study population Patients undergoing elective laparoscopic colorectal cancer resection at Zealand University Hospital, before and after 1st. of April 2016 are eligible for the study. Patients with a preoperative use of opioids within the last 3 months, undergoing a palliative resection or had a surgical complication leading to reoperation in general anesthesia will be excluded. Palliative resection is defined as patients with symptomatic metastatic colorectal cancer that undergoes resection of the primary tumor with the aim to relieve symptoms such as obstruction, bleeding or perforation.

Before April 1st. 2016 all patients, regardless of cardiovascular morbidity or kidney disease, received ibuprofen 400 mg in combination with paracetamol 1000 mg four times a day in the postoperative period and until admission. After April 1st the patients only received paracetamol. If the standard analgesic regimen was insufficient, patients in both groups were treated with intravenous, subcutaneous or oral opioids defined as drugs within the ACT-code (Anatomical Therapeutic Chemical Classification System) N02A. The department has a well-implemented Enhanced Recovery After Surgery (ERAS) program with a standardized management of the perioperative course and discharge with no other changes in the program in the study period.

Demographic and perioperative data including length of stay and postoperative complications within 30 days will be collected from the national prospective database of the Danish Colorectal Cancer Group. According to the exclusion criteria all patients with a registered surgical complication clavien dindo ≥3b will be excluded. The postoperative medical complications are categorized in the database in: Stroke, acute myocardial infarction, aspiration, pneumonia, heart failure, lung embolism, respiratory insufficiency, kidney failure, sepsis, deep venous thrombosis, arterial embolism and "other medical complication". The medical complications are also graded according to the clavien-dindo classification system. Daily postoperative opioid consumption until discharge, readmissions within 30 days, colorectal cancer recurrence or all-cause mortality are retrospectively collected from the electronic patient journal system (EPIC/OPUS).

Blood samples of creatinine and C-Reactive Protein are collected with one baseline preoperative sample (within 30 days before the operation) and postoperative day 1 to 7. Most patients will be discharged 2 to 3 days after the operation. Creatinine will be analyzed as a delta value of the baseline and the postoperative maximum serum creatinine value. In the analysis of CRP the investigators will compare the postoperative in-hospital peak-value.

Troponine I is a biomarker of MINS (myocardial injury after non-cardiac surgery) that was measured in the study period on postoperative day 1 to 4 or until discharge. Troponine I values will be categorized in \< 15, 15-45 and \>45.

Study outcome The primary outcome measure is changes in opioid use between the two groups (+/- NSAID), calculated as oral morphine equivalent (omeq) doses in mg. The secondary outcome measures are length of stay, postoperative medical complications within 30 days, changes in postoperative troponine I and creatinine, colorectal cancer recurrence and all-cause mortality.

A subgroup analysis of the primary outcome with patients who underwent a laparoscopic resection (including robotic assisted surgery) as well as a subgroup analysis excluding all patients with a surgical complication will be done.

Power calculation The sample size calculation was based on non-parametric testing regarding the primary outcome. The minimally clinically relevant difference in opioid consumption between the two groups was estimated to 25 % with a standarddeviation of 37.5 oral morphine equivalent (omeq). To detect a difference with a power of 80 % and an error alpha of 0.05 the total sample size was estimated to 502 patients - 251 patients in each group.

Statistical analyses Data will be analyzed using non-parametric tests. For dichotomous data Chi-square/Fishers exact test will be used and quantitative data will be analyzed using the Mann-Whitney test.

Does Omission of NSAIDs After Colorectal Cancer Operation Affect the Consumption of Opioids?

Effects on Omission of NSAIDs on the Consumption of Opioids in the Standard Analgesic Regimen After Elective Laparoscopic Colorectal Cancer Resection in an ERAS Setting. A Retrospective Single-center Cohort Study.

potential changes in the total p.n. use of opioids measured in oral morphine equivalent doses in mg (omeq)

Potential differences in postoperative peak serum - creatinine compared to preoperative serum-creatinine (\< 30 days preoperative)

Potential differences in serum Troponine I as a sign of MINS (myocardial injury after non-cardiac surgery).

A recurrence of colorectal cancer 120 days after primary surgery registered in the Danish national patient register

Zealand University Hospital

Principal investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Leiomyoma

Myofibroma

Dysmenorrhea

Uterine Diseases

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Menstruation Disturbances

Pelvic Pain

Neoplasms, Connective Tissue

Connective Tissue Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Naproxen

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Participants will be randomized to take either a placebo pill or a single 550 mg naproxen sodium pill. Randomization with a block size only known by the statistician, will be programmed to be allocated out of REDcap.

Our clinical research pharmacy will provide naproxen and an identical looking placebo in containers with codes only known to the statistician to provide a double-blinded experimental design.

On a subsequent episode of menstrual pain (1-2 months later), participants will receive the opposite treatment and undergo the exact same assessments.

Participants will receive placebo first in this arm.

Participants will be randomized to take either a placebo pill or a single 550 mg naproxen sodium pill.

Naproxen Sodium

Ellen Garrisn, BS RN

Kat Dillane, B.S.

Kevin Hellman, PhD.

Kevin M Hellman, PhD

There are limited treatment options for management of dysmenorrhea, and the physiological processes they affect are not completely understood. For example, NSAIDs are effective in reducing menstrual pain in some women by inhibition of prostaglandin synthesis, but whether those effects are mediated by affecting contractility, perfusion, or hypoxemia is unknown. Understanding how these drugs relieve menstrual pain (and why they fail) would be of substantial clinical significance. Given the foregoing, Two Specific Aims are proposed:

Aim #1: Characterize menstrual pain phenotypes associated with impairments in myometrial activity, perfusion, and/or oxygenation. Continuous MRI scans of the uterus will be performed with simultaneous measurement of self-reported pain in healthy women and those experiencing menstrual pain. The investigators will include cohorts of women with imaging diagnosed leiomyoma and surgically-confirmed endometriosis to evaluate the contribution of structurally identifiable factors. Based on preliminary data, the investigators anticipate finding four phenotypes with menstrual pain related to: 1) myometrial activity, 2) inadequate perfusion and/or oxygenation, 3) a combination of phenotypes 1 \& 2, and 4) a non-uterine source.

Aim #2: Evaluate the effects of naproxen on myometrial activity, perfusion, and/or oxygenation with respect to pain relief. In women with primary dysmenorrhea, the investigators will acquire pelvic MRI scans and evaluate self-reported menstrual cramping pain before and after administration of randomized naproxen or placebo.

Naproxen could principally affect one or more potential sources of uterine pain such as myometrial activity, perfusion, and/or oxygenation. The investigators will corroborate preliminary data findings, which suggest menstrual phenotypes with myometrial activity will be more likely to respond. Conversely, Aim 2 will also elucidate the mechanisms responsible for inadequate pain relief from naproxen.

Bioavailability of naproxen levels and other molecules associated with NSAID-resistance will be evaluated from the serum of participants after taking naproxen using HPLC-MS.

Due to a lack of noninvasive tools to study uterine physiology, the root causes of menstrual cramping pain within primary dysmenorrhea and secondary dysmenorrhea (leiomyoma, endometriosis, adenomyosis) remain unknown. This pain does not respond to typical over-the-counter anti-inflammatories in 15% of women and is a leading risk factor for developing challenging chronic pelvic pain disorders. In order to guide drug discoveries and create personalized treatment approaches, it is essential to unveil the underlying mechanisms of dysmenorrhea. Our research program has focused on key gaps in our knowledge of uterine physiology, such as the contributions of uterine contractions, perfusion, and oxygenation to menstrual pain. Although these factors are strongly implicated in this debilitating pain disorder, confirmatory human data is still needed. Such research would be quite timely, as numerous drug candidates targeting these potential mechanisms already exist. Our collaborative team has developed MRI-based tools to noninvasively and dynamically measure uterine contractions, perfusion, relative tissue oxygenation, and metabolites indicative of anaerobic respiration. The investigators have also pioneered methods that link spontaneous pain report to simultaneous uterine events. Together, these methods will allow us to evaluate the contribution of contractility, perfusion, or hypoxemia to menstrual pain. Notably, our preliminary data supports our central hypothesis that menstrual pain is associated with different phenotypes involving myometrial hypercontractility, impaired uterine perfusion, uterine hypoxemia, or a non-uterine source. Since understanding how current anti-inflammatory medications relieve or prevent pain (and why they fail) is valuable for the development of improved treatment strategies, the investigators will also investigate the effects of naproxen on uterine physiology in women with menstrual pain. To test our hypothesized contributions of altered uterine muscle activity, perfusion, and oxygenation on pain, The investigators propose: Aim 1: Characterize menstrual pain phenotypes associated with impairments in myometrial activity, perfusion, and/or oxygenation. Continuous MRI sequences of the uterus will be performed with simultaneous measurement of self-reported pain in healthy women and those experiencing menstrual pain. A cohort of women with leiomyoma and endometriosis will also be analyzed to evaluate the contribution of myometrial activity, perfusion, and oxygenation in women with structurally identifiable conditions. Aim 2: Evaluate the effects of naproxen on myometrial activity, perfusion, and/or oxygenation with respect to pain relief. Preliminary data suggests unresolved myometrial activity and inadequate naproxen absorption are associated with insufficient pain relief. Evaluating the naproxen-dependent effects of uterine physiology will provide a foundation for diagnostic tests to indicate relevant personalized treatment for patients that have failed conventional treatments. Further translation of these studies could advance mechanisms for discovery in other chronic pelvic pain conditions and uterine disorders such as idiopathic preterm labor and unexplained infertility.

Participants must have a uterus and must not be undergoing hormone therapy.

Mechanistic Characterization of Uterine Pain

Mechanistic Characterization of Uterine Pain (MCUP) to Improve Diagnosis and Treatment for Dysmenorrhea

The investigators will calculate the change in R2\*, ASL (arterial spin label), HASTE, and BOLD (Blood Oxygen Level Dependent) signal for each menstrual pain phenotype.

Principal component analysis of derived MRI signal variables and subsequent scree plotting will be used to reduce the dataset to 4-6 representative parameters that meaningfully separate potential phenotypes via hierarchical cluster analysis (R cluster library). Cluster dissimilarity metrics will be used to establish the probable number of phenotypes. Thus, our analyses are not entirely dependent on hypothesized phenotypes. A post-hoc ANOVA will be performed on relevant signal intensity variables to validate differences between the phenotypes. A post-hoc ANOVA will also be performed to compare whether there are differences in R2\*, ASL, HASTE, and BOLD signals between primary dysmenorrhea, endometriosis and leiomyoma participants.

Data will be processed similarly to Outcome #1. The investigators will use a repeated measures ANOVA and ANCOVA to examine changes in mean R2\*, ASL, HASTE, or EPI-BOLD signal intensity (4 dependent variables) after naproxen and/or placebo administration in all women with primary dysmenorrhea-regardless of cluster identity or phenotype. The investigators will also use an ANCOVA to examine whether the 4 MRI metrics of uterine physiology are related to changes in pain, using the difference of VAS (Visual Analog Scale) after naproxen minus the VAS before naproxen as a covariate. The investigators will detect for ANCOVA assumptions (e.g., homogeneity of variance, normality) and utilize appropriate corrections (transformation, permutation analysis) when needed.

The investigators will also use a paired X2 (McNemar) test to establish reliability of the repeat scans and examine differences in cluster/phenotype categorization across visits. The combined use of principal component analysis, hierarchical testing, and validation by a repeatability test follows recommended guidelines

Since participants with anatomical anomalies are provisionally excluded, the investigators will perform a sensitivity analysis by measuring the impact of provisional exclusion on linkage distance on clusters from Aim #1. Similarly, the impact of endometriosis and leiomyoma on cluster linkage distance will be calculated using recommended methods. Exploratory posthoc ANOVA/ANCOVAs will be performed within individual phenotypes/clusters identified in Aim #1 including endometriosis and leiomyoma to identify phenotypic-specific effects as a secondary analysis for Aim #2.

The investigators will calculate the correlation coefficient between NSAID resistance (defined as visual analog scale pain at 6 hours minus baseline pain) and age, parity, abuse (SPAQ score), anxiety (PROMIS Tscore), depression (PROMIS T-score), central pain sensitization (pain pressure thresholds). To accommodate differences in dimensionality we will use a combination of spearman, pearson, kendalls regression methods.

The investigators will calculate the correlation coefficient between NSAID resistance (defined as visual analog scale pain at 6 hours minus baseline pain) and absorbed serum Naproxen (90 minutes).

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NorthShore University HealthSystem

Research Associate Professor

Carcinoma

Reproductive Control Agents

Gastrointestinal Agents

Herbal and Botanical

Indomethacin

Esomeprazole

Celecoxib

Cyclooxygenase 2 Inhibitors

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Tocolytic Agents

Cola

Indomethacin, celecoxib, esomeprazole

Kent Lundholm, MD, prof

The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer.

Study and control patients are randomized to receive preoperative treatment with indomethacin or celecoxib compared to sham treatment.Tumor biopsies are taken at operation and used for analyses of tumor immunity and gene expression.

Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients

Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions

Göteborg University

Gland and Hormone Related Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Parecoxib

Loxoprofen

Parecoxib (iv.) for once \& Loxoprofen (po.) for routine use during the first 3 postop. days.

Tramadol (im.) for once \& Tramcontin (po.) for routine use during the first 3 postop. days.

Immediately after the operation, the patient is given (parecoxib 40 mg + sodium chloride 100 ml) intravenously once, and then given (loxoprofen 60 mg) orally twice a day during the first three postoperative days.

Immediately after the operation, the patient is given (tramadol 100 mg) intramuscularly once, and then given (tramcontin 100 mg) orally twice a day during the first three postoperative days.

Bing Xing, MD

Xiaopeng Guo, MD

Wei Lian, MD

We hypothesize that the effects of non-steroidal anti-inflammatory drugs (NSAIDS) for pain relief among patients with pituitary adenomas undergoing transnasal transsphenoidal surgeries are non-inferior to tramadol. We aim to launch a single-center randomized clinical trial to verify this hypothesis.

Postoperative pain is an important clinical concern and quality-of-care metric, yet it is undertreated in neurosurgical patients. Approximately 40% of inpatients complain of severe pain postoperatively, and only 56% of these patients indicate that their pain is well controlled. In addition, pain is a common cause of delayed discharge and unplanned hospital readmission.

Pituitary adenoma is the second most common benign primary central nervous system tumor, and transnasal transsphenoidal (TTS) has long taken over craniotomy to be the first-line surgical approach for pituitary tumor resection. TTS significantly reduces patient's surgical trauma, shortens the operation time, reduces surgery-related complications, and increases total tumor resection rate compared with the previously used craniotomy. However, given that the nasal mucosa is extremely sensitive, the feeling of pain is more obvious after surgery via TTS approach than via craniotomy.

Opioids such as morphine and pethidine are the most effective post-surgical analgesics, but they have a series of side effects, such as drug addiction, decreased gastrointestinal motility, nausea and vomiting. Opioids are not an analgesic that must be used after TTS surgery. NSAIDS, such as parecoxib and lexone, and tramadol are also commonly used analgesics after surgery, and they are also effective. NSAIDS is a first-tier painkiller, and tramadol is a second-tier drug. There is no evidence-based evidence recommending the preferred choice of these two drugs. Which of NSAIDS and tramadol has the better analgesic effect and which drug brings lower side effects to patients is still unclear. The clinical application of the two drugs is entirely based on the personal habits of the surgeon.

Therefore, we plan to conduct a prospective randomized controlled trial to explore: whether the analgesic effect of NSAIDS is non-inferior than tramadol; and whether the side effects of NSAIDS are not higher than tramadol. This result will guide us in clinical pain management for patients with pituitary adenomas after surgery via TTS approach.

Participants are assigned to one of two groups in parallel during the study, using the method of randomization. The ratio is 1:1.

The participant, investigator and outcome assessors are all prevented from having knowledge of the interventions assigned to individual participants. Only the care provider knows individual specified intervention.

Pain Management After Transnasal Transsphenoidal Surgery for Pituitary Adenomas

Non-Steroidal Anti-inflammatory Drugs (NSAIDS) vs. Tramadol in Pain Management After Transnasal Transsphenoidal Surgery Among Patients With Pituitary Adenomas: A Prospective Randomized Controlled Trial

The individual participant data can be made available upon reasonable request to the study chair, Dr. Bing Xing, or the study director, Dr. Wei Lian.

Including but not limited to nausea, vomiting, upset stomach, stomach pain, gastrorrhagia, dizziness and skin rash, while using these drugs

visual analogue scale score that represents the patient's subjective pain perception

Peking Union Medical College Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Stomach Neoplasms

Lung Neoplasms

Pancreatic Neoplasms

Wasting Syndrome

Cachexia

Biliary Tract Neoplasms

Syndrome

Biliary Tract Diseases

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Stomach Cancer

Pancreatic Cancer

Biliary Tract Cancer

Other Dietary Supplements

Omega 3 Fatty Acid

Daily oral medications: ibuprofen 400 mg three times a day, omega-3-fatty acid 1 g twice a day, Bojungikki-tang 3.75g twice a day, oral nutritional supplement (HAMONILAN SOLN) 200 ml twice a day Weekly physical exercise by physiatrist (60 minutes per visit) Biweekly psychiatric intervention Nutritional counselling total four times during the study period

Multi-modal intervention

Chi Hoon Maeng, M.D.

Bo-Hyung Kim, M.D.

Kil Yeon Lee, M.D.

Background

Cancer Cachexia (CC) is a multi-factorial process characterized by progressive weight loss, muscle mass and fat tissue wasting, and adversely affecting their quality of life and survival in patients with advanced stage of cancer.

Megestrol acetate (MA), which can help maintain body weight in advanced cancer patients, has not been proven to be effective in improving quality of life or lean body mass. Furthermore, its use is often limited due to various adverse event such as Cushing syndrome, adrenal insufficiency, or thromboembolic risk.

CC has a complex and multi-factorial pathophysiology, and there is no established standard treatment.

Hypothesis CC is irreversible once it occurs and is also difficult to suppress its progression with any single treatment modality.

The investigators hypothesized that a multi-modal intervention comprised of anti-inflammation, omega-3-fatty acids, oral nutritional supplement with counselling by nutritionist, physical exercise, psychiatric intervention as well as Bojungikki-tang which mediates immune-modulation and reverse both of chronic inflammation and wasting condition as a complementary and alternative medicine (CAM) could prevent the development of CC or improve the CC in advanced cancer patients during chemotherapy compared to those who received usual supportive.

\[PICOT\] Population: Patients with recurrent or metastatic solid cancer (gastric, colorectal, pancreas, biliary tract and lung)

Intervention: Multimodal treatment

Comparison: Conventional palliative care

Outcome: Change of total lean body mass, Change of handgrip strength Time: 12 weeks of study period for each subject during the first- or second-line palliative chemotherapy

Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE)

Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE): An Open-label, Phase 2 Tria

After anonymizing the patient's confidential information, it can be converted into data and shared.

The average of the change (kg) from baseline at week 7 and change from baseline at week 13 measured by DEXA (dual-energy X-ray absorptiometry)

The average of the change (kg) from baseline at week 7 and change from baseline at week 13 measured by the calibrated scale

Functional Assessment of Anorexia/Cachexia Treatment (FAACT) version 4, The higher the score, the better the quality of life (QoL) with range 0-156.

The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.

Assessed by the investigator, based on toxicity grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Pain Therapeutic Effects After Benign Mastectomy	NCT00519246	Pain, Postopera... Mastectomy	Saline Opioid Opioid NSAID NSAID Opioid Opioid	18 Years - 64 Years	Nanjing Medical University
Does Omission of NSAIDs After Colorectal Cancer Operation Affect the Consumption of Opioids?	NCT04448652	Colo-rectal Can...	NSAID	18 Years -	Zealand University Hospital
Mechanistic Characterization of Uterine Pain	NCT04145518	Dysmenorrhea (D... Dysmenorrhea Pr... Dysmenorrhea Se... Endometrial Dis... Leiomyoma Fibroid Uterus	Naproxen Sodium	18 Years - 45 Years	NorthShore University HealthSystem
Comparison of Pain Therapeutic Effects After Benign Mastectomy	NCT00519246	Pain, Postopera... Mastectomy	Saline Opioid Opioid NSAID NSAID Opioid Opioid	18 Years - 64 Years	Nanjing Medical University
Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients	NCT00473980	Colorectal Canc...	Indomethacin, c...	40 Years - 80 Years	Göteborg University
Pain Management After Transnasal Transsphenoidal Surgery for Pituitary Adenomas	NCT04611685	Pituitary Adeno... Surgery Pain	NSAID Tramadol	18 Years - 70 Years	Peking Union Medical College Hospital
Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients	NCT00473980	Colorectal Canc...	Indomethacin, c...	40 Years - 80 Years	Göteborg University
Effect of Multi-modal Intervention Care on Cachexia in Patients With Advanced Cancer Compared to Conventional Management (MIRACLE)	NCT04907864	Gastric Cancer Colorectal Canc... Pancreatic Canc... Biliary Tract C... Lung Cancer Precachexia Cachexia	Multi-modal int...	19 Years -	Kyunghee University Medical Center
Physiological Effects of Altering Cancer-related Inflammation	NCT01786200	Colon Cancer	Aspirin Ibuprofen	18 Years - 75 Years	NHS Greater Glasgow and Clyde
Anesthesia and Immunological and Oxidative Stress in Relation to Abdominal Cancer Surgery	NCT03974984	Anesthesia Colon Cancer Surgery	Colon Resection Epidural anesth... NSAID	18 Years -	University of Copenhagen
Comparison of Pain Therapeutic Effects After Benign Mastectomy	NCT00519246	Pain, Postopera... Mastectomy	Saline Opioid Opioid NSAID NSAID Opioid Opioid	18 Years - 64 Years	Nanjing Medical University
Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients	NCT00473980	Colorectal Canc...	Indomethacin, c...	40 Years - 80 Years	Göteborg University

Spots Global Cancer Trial Database for nsaid

Every month we try and update this database with for nsaid 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 nsaid

Every month we try and update this database with for nsaid 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 nsaid 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.