Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Pain

Head and Neck Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Antitussive Agents

Central Nervous System Depressants

Respiratory System Agents

Antipyretics

Anti-Obesity Agents

Vasoconstrictor Agents

Ketoprofen

Codeine

Acetaminophen

Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Analgesics, Opioid

Narcotics

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)

Paracetamol

Ketoprofen\* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day.

Danièle LEFEBVRE-KUNTZ, MD

Nathalie LEROUX-BROMBERG, MD

Danièle Lefebvre-Kuntz, MD

Nathalie Leroux-Bromberg, MD

Abesse Ahmeidi, MD

Agnès Hamdani, MD

Eliane Boufflers, MD

Eric Lartigau, MD

Bernard Coche-Dequeant, MD

Abel Cordoba, MD

Sophie Maillard, MD

Didier Delbrouck, MD

Nathalie LEROUX, MD

The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.

* Selection criteria validation
* Patient information and collection of a signed informed consent
* Randomization
* Completion of HADS questionnaire
* Day 1 = Begin of analgesic treatment / brachytherapy
* T-30= 30 minutes before the operative procedure, IV administration of the analgesic treatment (Arm A or B) by the anesthetist
* T0= end of the operative procedure under general anesthesia
* T4, T8, and T12 = 4, 8 and 12 hours after T0: evaluation of pain level. If pain level ≥ 4:

  1. paracetamol-codeine (Arms A and B) and continuation of ketoprofen (Arm B). Then, if persistence of pain :
  2. paracetamol and morphine (Arms A and B)
* Day 2 to Day 30: At home or during hospital stay:

Pain assessment twice a day by the patient until absence of pain during 2 consecutive days

* Day 3 and Day 15: Pain assessment or phone interview by the algologist of the investigation center ; completion of a HADS questionnaire on Day 3
* Day 30= End of study: Pain assessment by the algologist of the investigation center and HADS questionnaire

In any case, pain assessment must be done until absence of pain during 2 consecutive days

Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)

Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study

Immediate post-operative pain will be assessed on a scale from 0 to 10. Experimental treatment will be considered as a success if the level of pain is \< 4, 4 hours after the surgical operation.

Assessment of the pain level at 8, 12 hours after the operative procedure, then twice a day during hospital stay or at home until the absence of pain during 2 consecutive days. This level will also be measured at days 3, 15 and 30 at hospital or during a phone interview (Days 3 and 15) and by the algologist of the investigation center on Day 30.

Santelys Association

Centre Oscar Lambret

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Acute Pain

Neurologic Manifestations

Acute Graft Versus Host Disease

Adjuvants, Anesthesia

Platelet Aggregation Inhibitors

Anesthetics

Fentanyl

Oxycodone

Rocuronium

Ropivacaine

Propofol

Sevoflurane

Succinylcholine

Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.

After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.375% ropivacaine will be performed. Then, the patient will be treated as in the controlled group.

After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.9% saline will be performed. Then, the patient will be treated as in the controlled group.

Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).

Erector spinae plane block

Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).

Sham block

Standard general anesthesia. The induction with fentanyl, 1-3 mcg per KG; propofol, 1.5-2 mg per kg. Then, the laryngeal mask airway will be inserted. Patients with the risk of aspiration will be intubated using rocuronium or suxamethonium.

The maintenance with oxygen/air mixture, sevoflurane, and fentanyl.

General anesthesia

All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)

Patient-controlled analgesia

Intravenous oxycodone will be administered about 30 minutes before the end of the surgery at a dose of 0.1 mg/KG. Additional 2 doses can be given if pain on the visual analog scale will be higher than 40.

intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

paracetamol

Paweł Piwowarczyk, MD-PhD

Patients scheduled for breast surgery due to cancer. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Patients will be allocated to one of three groups: erector spinae plane (ESP) block, sham block, controlled group.

Only patients who are qualified for an elective procedure of mitral breast surgery may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: propofol, fentanyl, rocuronium. The airway will be secured with a laryngeal mask airway (LMA). When there is a risk of aspiration, the patient will be intubated. Then, rocuronium or suxamethonium will be used. The anesthesia maintenance: sevoflurane, fentanyl. The emergence: oxygen, sugammadex or neostigmine a required.

After the induction of general anesthesia, an opaque envelope with the selected group will be opened. In the controlled group, the procedure will be continued in the patient's supine position. Women from the ESP and Sham groups will be placed in the lateral position. The operated side will be above. Then, the ultrasound-guided ESP block with saline or ropivacaine will be performed.

At the end of the surgery, an anesthesiologist will administer oxycodone intravenously (0.1 mg/KG).

After emergence from anesthesia, the patient will be transferred to the postoperative care unit. Vital signs will be monitored. The patient-controlled analgesia pump with oxycodone will be used.

The patient: The primary intervention (erector spinae plane block) will be provided under general anesthesia.

The investigator and outcome assessor will be not aware of the allocation.

ESP in Breast Surgery Due to Cancer

Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer

Quality of recovery (QoR) score containing 40 items. This questionnaire measures the early postoperative health status of patients. Minimum is 40, maximum is 200. More points is better.

Acute pain measured with VAS (visual analog scale). From 0 (no pain) to 100. More on the scale is worse.

Consumption of oxycodone with PCA pump, loading, and additional doses.

Medical University of Lublin

associate professor

Digestive System Diseases

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Syndrome

Esophageal Neoplasms

Nutrition Disorders

Gastroparesis

Dumping Syndrome

Feeding and Eating Disorders

Gastrointestinal Diseases

Stomach Diseases

Paralysis

Postgastrectomy Syndromes

Postoperative Complications

Mental Disorders

Psychotic Disorders

Esophageal Cancer

Hypoglycemic Agents

Pharmaceutical Solutions

Anti-Infective Agents

Gastrointestinal Agents

Antineoplastic Agents

Insulin

Insulin, Globin Zinc

Hormones

Somatostatin

Glucagon-Like Peptide 1

Sulfasalazine

Octreotide

Antineoplastic Agents, Hormonal

50mcg octreotide acetate by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge

Octreotide Acetate

Equivalent volume of 0.9% saline by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge

Saline Solution

Paracetamol 1g by mouth consumed with a 400kcal mixed meal challenge

1g sulfasalazine by mouth consumed with a 400kcal mixed meal challenge

Biopsy from the second part of the duodenum taken at routine endoscopic surveillance, undertaken for another clinical indication.

Duodenal biopsy

John V Reynolds, MD FRCS

Carel W le Roux, FRCP FRCPath PhD

The incidence of oesophagogastric cancer has increased by 400% since the 1970s in Ireland and the United Kingdom. In addition, refinement of perioperative management and the now widespread use of multimodal protocols for patients with locally advanced disease have significantly improved outcomes for patients with oesophagogastric cancer treatable with curative intent. Despite significant advances in chemoradiotherapy, surgical resection remains the primary curative option.

Unintentional weight loss and nutritional complications represent serious concerns for patients after radical resection, even among those who remain free from recurrent disease in the long-term. A study from the Swedish Esophageal and Cardia Cancer Registry reported a mean three year weight loss of 10.8% among disease-free patients, with 33.8% of this cohort demonstrating malnutrition at three years post-oesophagectomy.

Mechanisms contributing to weight loss for disease-free patients after upper gastrointestinal surgery are poorly understood, however an association between increasing magnitude of weight loss and the presence of increased satiety is described. Our recent studies at SJH have demonstrated four fold elevated postprandial satiety gut hormone concentrations after oesophagectomy, compared with baseline preoperative values. Postprandial gut hormone levels correlate significantly with postprandial symptoms and altered appetite at 3 months postoperatively, and with body weight loss at 2 years postoperatively. However, the mechanism leading to exaggerated postprandial gut hormone production after upper gastrointestinal surgery is poorly understood, limiting targeted therapeutic options.

In this study, we aim to characterise the role of altered nutrient transit and enteroendocrine cell function in the pathophysiology of excessive post-prandial gut hormone responses after upper gastrointestinal surgery. To do this, we will measure the gut hormone response to a standardised 400 kcal meal, as per previous studies, while concurrently assessing gastrointestinal transit time, and enteroendocrine cell morphology and function. In this way, we will determine whether the magnitude of the postprandial gut hormone response correlates with the rate of nutrient transit into the enteroendocrine L-cell rich small intestine, and whether enteroendocrine cell adaptation occurs after oesophagectomy.

Furthermore, we have previously observed that gut hormone suppression using octreotide is associated with increased ad libitum among subjects after upper gastrointestinal cancer surgery (Elliott JA et al, Annals of Surgery, 2015). The mechanism of action of octreotide may relate to SSTR-5-mediated negative feedback to the enteroendocrine L-cell, but this medication may additionally reduce enteroendocrine L-cell responses through its inhibitory effect on gastrointestinal motility - reducing the rapidity with which nutrients are delivered to the small intestine - and small intestinal nutrient sensing via inhibition of the Na+-dependent glucose transporter SGLT-18-10. Through conduction of this double-blind, randomised, placebo-controlled crossover study, we aim to establish the mechanism of action of octreotide-mediated increased food intake in patients after gastrointestinal surgery. This may inform the design of future targeted interventions for this patient group.

Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery

St. James's Hospital, Ireland

Clinical Research Fellow

Paget Disease, Extramammary

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Extramammary Paget Disease

Anti-Arrhythmia Agents

Channel Blockers

Dermatologic Agents

Lidocaine

Imiquimod

Petrolatum

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Emollients

Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.

topical 5% imiquimod cream 3 times a week for 16 weeks.

lidocaine in Vaseline ointment

Joanne de Hullu, MD PhD

The purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar Paget's disease.

Vulvar Paget's disease is a rare skin tumour and generally seen in postmenopausal, Caucasian women as an erythematous, eczematous, scaling or ulcerating plaque. Initial symptoms are irritation, burning, pain and a skin lesion. The origin of vulvar Paget's disease is not yet entirely understood. The treatment of choice is surgical excision, despite high recurrence rates. The mutilating consequences of surgery can lead to impressive morbidity to address this, several series report the use of topical 5% imiquimod cream for vulvar Paget's disease.

The objective of this study is to assess the efficacy, evaluate the safety, immunological effect of topical 5% imiquimod cream for vulvar Paget's disease and the quality of life during treatment.

Topical 5% Imiquimod Cream for Vulvar Paget's Disease

Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response

Clinical response will be assessed by vulvar examination and measurement and is defined as complete remission, partial remission (decrease by ≥50% of total lesion size) or no remission.

Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions:

1. Have you used paracetamol during treatment?

   1. How many days?
   2. What dosage?
   3. Was the use sufficient?
2. Have you used lidocaine in Vaseline ointment during treatment?

   1. How many days?
   2. What dosage?
   3. Was the use sufficient?
3. Have you stopped the treatment with imiquimod because of side effects/pain?

Most common adverse events will be evaluated with the following questions:

1. Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
2. Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
3. Have you felt more tired than you normally are? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.

Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of

The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.

The questionnaire DLQI (Dermatology Life Quality Index) will be used.

The questionnaire FSDS (Female Sexual Distress Scale) will be used.

Leiden University Medical Center

University Medical Center Groningen

Erasmus Medical Center

The Netherlands Cancer Institute

UMC Utrecht

Catharina Ziekenhuis Eindhoven

University Medical Center Nijmegen

MD PhD

Infections

Wounds and Injuries

Communicable Diseases

Hyperthermia

Fever

Body Temperature Changes

All patients will receive one single dose of 1000mg paracetamol.

All patients will receive one single dose of 1000mg paracetamol. If considered mandatory by the attending physician, similar doses may be administered latter for a maximum period of five days. The maximum allowed daily dose is 3000mg. If the attending physician believes that after the administration of at least of three doses the desired analgesic or antipyretic effect is not achieved, he may administer any other compound in his will.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)	NCT02439034	Uterine Cervica... Upper Aerodiges...	Paracetamol Ketoprofen	18 Years - 75 Years	Centre Oscar Lambret
ESP in Breast Surgery Due to Cancer	NCT04726878	Breast Cancer Pain, Acute Anesthesia, Loc...	Erector spinae ... Sham block General anesthe... Patient-control... Oxycodone paracetamol	18 Years - 80 Years	Medical University of Lublin
Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery	NCT03734627	Esophageal Canc... Nutrition Disor... Appetite Disord... Dumping Syndrom... Delayed Gastric... Surgery	Octreotide Acet... Saline Solution Paracetamol Sulfasalazine Duodenal biopsy	18 Years -	St. James's Hospital, Ireland
Topical 5% Imiquimod Cream for Vulvar Paget's Disease	NCT02385188	Paget Disease, ...	Imiquimod paracetamol lidocaine in Va...	18 Years -	University Medical Center Nijmegen
Paracetamol as Antipyretic and Analgesic Medication	NCT01070732	Fever Analgesia	Paracetamol	18 Years -	University of Athens
Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control	NCT05088876	Pain	Placebo Paracetamol	18 Years -	Insel Gruppe AG, University Hospital Bern
Paracetamol for Cancer Pain	NCT01313247	Advanced Cancer Opioid Use, Uns...	paracetamol placebo tablets	18 Years -	Haraldsplass Deaconess Hospital
A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL)	NCT04660799	Lymphoma, Large...	Rituximab IV Rituximab SC Rituximab IV Cyclophosphamid... Doxorubicin Vincristine Prednisone Paracetamol Diphenhydramine...	18 Years - 80 Years	Hoffmann-La Roche

Spots Global Cancer Trial Database for paracetamol

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

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