Nervous System Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Neuralgia

Peripheral Nervous System Diseases

Pain

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neuromuscular Diseases

Neurologic Manifestations

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Patients will not receive any intervention during their oxaliplatin chemotherapy cycles.

Patients will receive three photobiomodulation sessions per week during their oxaliplatin chemotherapy cycles

In oncology, photobiomodulation is used to help heal damaged tissues, improve immune response, reduce inflammation, and prevent or treat certain side effects of treatments such as chemotherapy. Photobiomodulation is also the subject of recent clinical studies to expand its indications (peripheral neuropathies induced by certain chemotherapies.

Patients in the experimental group will receive 3 photobiomodulation sessions per week during their oxaliplatin treatments (6 months), for a total of 72 sessions. Exposition to laser light is 30 minutes for each session.

Photobiomodulation

Morgane Pihan, MD

Morgane Pihan

Peripheral neuropathy is one of the most common side effects of oxaliplatin (OXA)-based chemotherapy for patients treated for digestive cancers, disabling and dose-limiting. Several strategies have been studied for the treatment of oxaliplatin-related sensory neuropathy. Several pharmacological and non-pharmacological therapeutic strategies have been explored to relieve peripheral neuropathic pain. Non-pharmacological interventions have been shown to be potentially beneficial for patients suffering from chemotherapy-induced neurotoxicity. The objective of this prospective study is to evaluate the effectiveness of photobiomodulation on the reduction of neuropathic pain in patients who developed painful, cumulative peripheral neuropathy that appeared under the effect of the treatment.

Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation

Is is a score with 12 items. 10 items concern pain and are scale from 0 (no pain) to 10 (maximal pain).

QLQ-C30 EORTC scale : 30 items scored from 1 (not at all) to 4 (very). Global health status, functional scales and symptom scales are reported.

Evaluation of peripheral neuropathy by SUDOSCAN (detection and evaluation of small fiber neuropathies)

Evaluation by electroneuromyogram : measurement of nerve conduction velocity

TNSc score : 7 items to explore sensitive and motor symptoms, scored from 0 (no symptom) from 4 (very important symptoms)

Saint-Gregoire Private Hospital Center

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Pancreatic Neoplasms

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Ischemia

Congenital Abnormalities

Adenomatous Polyposis Coli

Diverticulitis

Anastomotic Leak

Intestinal Obstruction

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Colonic Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Diverticulum

Diverticular Diseases

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Pancreatic Cancer

Familial Adenomatous Polyposis

MYH-associated Polyposis

Intraoperatively, ICG-NIRF imaging is used to visualize the blood supply and the rate of tissue perfusion in the area of the anastomotic site. Postoperatively, an additional ingress and egress analysis at specific regions of interest is performed.

intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) before and after anastomosis formation, postoperative analysis of ingress and egress for specific regions of interest

ICG-NIRF Imaging plus ingress and egress analysis

Benjamin Weixler, PD MD

Leonard Lobbes, MD

Benjamin Weixler, MD PD

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.

Near-infrared-fluorescence by indocyanine green (ICG-NIRF) utilises the fluorescent property of intravenously injected indocyanine green (ICG) as an intravascular indicator of tissue and bowel perfusion.

The investigators hypothesise that ICG-NIRF is a suitable, reliable and precise method of visualisation of the blood supply and bowel perfusion in the area of gastrointestinal and hepatobiliary anastomosis formation.

In this prospective, non-randomized cohort study, the respective upper GI, lower GI or hepatobiliary procedure with anastomosis is performed according to standard of care and indication for the corresponding disease including non-malignant, malignant and inflammatory conditions. The following procedures are included in the study, in open or laparoscopic surgery, according to the surgeon's choice:

Upper GI surgery:

* Esophageal resection
* Subtotal or total gastrectomy with or without jejunal pouch reconstruction
* Y-Roux-reconstruction
* Right or left colonic interposition (iso- or antiperistaltic)

Lower GI surgery:

* Jejunal or ileal segmental resection
* Ileal / Ileocoecal resection
* Colectomy with restorative ileal pouch formation and ileal-pouch-anal anastomosis
* Left or right-sided hemicolectomy
* Sigmoid resection
* Rectal resections (lower anterior resection (LAR), proctectomy with colo-anal anastomosis, abdominoperineal resection)
* Stoma closure

Hepatobiliary surgery:

- Pancreaticoduodenectomy

Written informed consent for participation and ICG-administration is obtained one day before surgery.

Intraoperatively, Indocyanine Green (ICG, VerDye, Diagnostic Green GmbH, Aschheim Germany, 25 mg vials) is dissolved in 5 mL sterile water to yield a 5 mg/mL concentration. It will then be administered intravenously at three consecutive time points as a bolus of 2 ml per time point at the most. The overall dose of ICG will amount to no more than 30mg of ICG per patient.

Real-time intraoperative visualization is performed with the SpectrumTM Fluorescence Imaging Platform (Quest Innovations, Middenmeer, The Netherlands) directly after each ICG injection assessing bowel perfusion at two different time points per anastomosis respectively: before and after anastomosis formation.

Postoperative NIRF-perfusion rate assessment Using the Quest Research SoftwareTM, the recordings before and after anastomosis formation will be analysed for their perfusion rate. This analysis will provide objective, quantitative data on the perfusion for a certain time frame which is determined by the length of the video recording. This data will be collected for statistical analysis and correlation with anastomotic leak as well as postoperative outcome.

Clinical data and follow-up Clinical data will be collected from all patients regarding anastomotic leak, bowel ischemia and necrosis as well as 30 day postoperative morbidity, mortality and length and cost of hospital stay.

Further data analysis will be performed using Microsoft Excel® and IBM SPSS®.

This is a non-randomised prospective cohort study design.

Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses

Objective Perfusion Rate Assessment of Gastrointestinal Anastomoses by Inflow and Outflow Analysis of Near-infrared Fluorescence Agents

number of patients suffering from an anastomotic leak within 30 days of operation

Clavien-Dindo for complication-level classification

Charite University, Berlin, Germany

Attending Physician, Assistant Professor

Behaviors and Mental Disorders

Respiratory Tract (Lung and Bronchial) Diseases

Anxiety Disorders

Depressive Disorder

Carcinoma

Carcinoma, Non-Small-Cell Lung

Depression

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

See methods below - standard strength and endurance training

See methods below - medical QiGong therapy session

The standard exercise therapy program will include 12 treatments of approximately 45 minutes duration, twice a week for a period of six weeks by the same instructor and at the same location as for Qigong therapy. This exercise program is supervised and consists of cardio-vascular and resistance training exercises. Participants are asked to refrain from practicing Qigong during this 6 week period.

Standard Exercise

Qigong therapy will be led by a trained Qigong instructor and will occur for 45 minutes sessions, twice a week for a period of six weeks. Qigong is a self-directed walking exercise program that involves arm movements that are coordinated with slight movements of the waist, while in a state of deep relaxation or meditation. Patients will be asked to refrain from independent resistance or cardiovascular training during this 6 week period.

Qigong Exercise

Thomas Jagoe, MD, PhD

Cancer patients face a number of symptoms related to treatment or disease which may impair quality of life, such as decreased functional capacity, fatigue, nausea an vomiting, distress, depression and unmet psychological needs. Due to this array of symptoms, cancer patients often seek supportive complementary and alternative medicine, which many patients use along with conventional treatments. Qigong, a type traditional chinese medicine, is a mind-body exercise that combines meditation, slow physical movements, and controlled breathing. The investigators hypothesise that Qigong therapy is better in the reduction of anxiety and depression levels and the improvement of quality of life in patients with lung and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to standard exercise training.

Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy

Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy

Peer-reviewed manuscripts and conference proceedings

Depression and anxiety will be measured using the Hospital Anxiety Depression Scale (HADS); The HADS is a 14-item self-rated questionnaire, consisting of two 7-item subscales. It was developed to identify anxiety and depression in non-psychiatric medical outpatients. Each item on the HADS is scored from 0 (no problem) to 3 (maximum distress). The HADS will be administered within 2 weeks of completing each exercise program.

The general version of the Functional Assessment of Cancer Therapy scale (FACT-G) will be used to measure Quality of Life (QoL) after completion of each 6 week exercise program. This questionnaire consists of 4 subscales: Physical well-being (PWB), Social well-being (SWB), Emotional well-being (EWB) and Functional well-being (FWB). A change of 4 points on the total FACT score is regarded as clinically significant.

Functional capcity will be measured using the Simmonds Functional Assessment (SFA) within 2 weeks of finishing each 6-week exercise program. This tool consists of eight items: putting on a sock, tying a belt, putting coins in a cup, reaching forward, repeated reach up (3 times), repeated sit to stand (2 times), speed walk for 50 feet, and walking for 6 minutes. Patient satisfaction will be measured by asking all participants to answer a two item questionnaire with a 10-point visual analog scale response option.

Symptoms commonly reported by lung and GI cancer patients will be measured using the Edmonton Symptom Assessment Scale (ESAS). The ESAS is a 12-item patient rated symptom questionnaire scored using a 10-point visual analogue scale. The ESAS will be administered within 2 weeks of completing each 6-week exercise program.

Patient satisfaction will be measured by asking all participants to answer a two-item questionnaire after they have completed each 6-week exercise program.

Jewish General Hospital

McGill University

Associate Professor of Medicine

Neoplasms, Unknown Primary

Neoplasm Metastasis

Neoplastic Processes

Anti-Infective Agents

Mebendazole

Anthelmintics

Antiparasitic Agents

Tubulin Modulators

Antimitotic Agents

ReposMBZ 100 mg capsule by mouth followed by 8h PK sampling to decide the initial daily dose.

Treatment: Repos MBZ capsules by mouth twice daily for 16 weeks, daily dose 50mg-4g, based on the serum level of mebendazole.

ReposMBZ

This study will evaluate the safety and efficacy of mebendazole (ReposMBZ) in patient with advanced gastrointestinal cancer or cancer of unknown origin. All patients will be given ReposMBZ for 16 weeks continuous treatment, individually dosed based on the serum concentration of mebendazole.

Mebendazole has been used extensively during long time for local gut helminthic infections at low dose but also at considerably higher doses during months to years against invasive echinococcus infections. Recent research has now clearly indicated that mebendazole has anticancer effect. Given these observations and the experience of excellent tolerance to mebendazole the current clinical trial protocol is based on the repositioning strategy to more extensively investigate whether mebendazole could be developed into a useful anticancer drug.

A Clinical Safety and Efficacy Study of Mebendazole on GI Cancer or Cancer of Unknown Origin.

A Phase 2a TDM-guided Clinical Study on the Safety and Efficacy of Mebendazole in Patients With Advanced Gastrointestinal Cancer or Cancer of Unknown Origin

Genetic changes and infiltration of immune cells, grade, molecular subtype, gene and protein expression and tumour infiltration and subtypes of macrophages and lymphocytes.

Changes in the properties analysed in the archived tissue (baseline) and the fresh biopsy.

Mean S-mebendazole concentration during treatment phase in relation to safety (CTCAE 4.03 grade 3 and 4 toxicity) and efficacy (tumour response and TTP) respectively.

Blood chemistry (plasma): Sodium, Potassium, Calcium, Glucose (mmol/L)

Blood chemistry (plasma): Bilirubin (µmol/L)

Blood chemistry (plasma): ALAT, ASAT, LDH, ALP (µkat/L)

Haematology: RBC (red blood cell count), White blood cells with differential count and platelets (absolute count/L)

Coagulation (plasma): Prothrombin complex (INR)

Systolic and diastolic blood pressure (mmHg) Weight (kg)

Best overall radiological response Time to tumour progression (TTP) compared with TTP on the treatment just preceding this protocol.

Cmax will be used to decide the starting dose in the treatment phase.

Analysis of serum concentration after single dose administration of ReposMBZ.

Cmax will be used to adjust the dose until target S-mebendazole level is reached and to show the individual variation of S-mebendazole concentration over time

Number of patients that reach the steady state S-mebendazole target concentration.

Time from first dose in treatment phase until target S-mebendazole concentration is reached

Change of cytokine levels in blood, evaluated by cytokine array.

Up-regulation of activation markers compared to baseline, evaluated by flow cytometry.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation	NCT06199115	Cancer of the G...	Photobiomodulat...	18 Years -	Saint-Gregoire Private Hospital Center
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses	NCT04709445	Bowel Obstructi... Bowel Ischemia Diverticulitis Abnormality of ... Symptomatic Dis... Stoma Ileostomy Cancer of the G... Crohn Disease Ulcerative Coli... Familial Adenom... Pancreatic Neop... Hepatobiliary N...	ICG-NIRF Imagin...	18 Years -	Charite University, Berlin, Germany
Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy	NCT01374100	Carcinoma, Non-... Cancer of the G...	Standard Exerci... Qigong Exercise	18 Years -	McGill University
A Clinical Safety and Efficacy Study of Mebendazole on GI Cancer or Cancer of Unknown Origin.	NCT03628079	Cancer of the G... Cancer of Unkno...	ReposMBZ	18 Years -	Repos Pharma

Spots Global Cancer Trial Database for cancer of the gastrointestinal tract