Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support...
Cancer DigestiveDig' Electrostim-01 is phase II, single center (step 1) and multicentre (step 2), single-arm study to evaluate an 8-week NMES intervention combined with nutritional support in addition to usual patient care
Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients
Non-Small-Cell Lung CarcinomaDigestive System Neoplasms1 moreAIM: To evaluate the effectiveness and efficiency of an innovative exercise program (EP) for patients during treatment for gastrointestinal tumors, breast and non small cells lung cancer, in terms of improved quality of life (QOL), fatigue and functional capacity respect the usual standard treatment (ST). DESIGN: Pragmatic randomized clinical trial in two parallel groups: EP and ST. SETTING: 7 Primary Health Centers (PHC) of the redIAPPISCIII, in coordination with oncology services. PARTICIPANTS: 250 patients with the above tumors, locally advanced or with metastatic disease, in adjuvant treatment, with Performance Status(PS) PS1-PS0. INTERVENTION: Both groups received standardized usual care. The EP group will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a second phase in community facilities during the remaining 10 months. MEASUREMENTS: The primary outcome measure is the change from baseline in the QOL+66 treatment, as measured by the specific questionnaire for patients with cancer EORTC QLQ-C-30 and Short Form(SF-36) overall. Secondary: fatigue (FACIT-F), radiological response, functional capacity (6 minutes walking and cardiopulmonary test), muscle strength and progression-free survival and overall. Predictors and confounders: age, sex, stage and tumor type, histology, treatment. ANALYSIS: We will compare between groups mean changes from baseline measurement of quality of life questionnaire (QOL) and other variables, on an intention to treat basis, using longitudinal mixed-effects models for repeated measures at 2, 6 and 12 months follow-up. Cost / effectiveness and cost / incremental utility associated to the program wil be estimated.
Screening to Predict Weight Loss in Patients With Cancer
CachexiaGastrointestinal Cancer4 moreRATIONALE: Screening tests may identify people with cancer who are at high risk of losing weight and help doctors plan better treatment. PURPOSE: This clinical trial is studying how well a new screening tool works in predicting weight loss in patients with cancer.
Celiac Plexus Radiosurgery for Pain Management
Digestive System NeoplasmsThis prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.
Tamoxifen in Patients With Oesophageal Cancer
CancerGastrointestinal NeoplasmsCancer of the gullet (oesophagus) is a lethal disease in which only 15% of patients survive 5 years once diagnosed. It is more common in men than women, and men appear to have a worse prognosis. One suggestion for this gender difference is the sex hormone oestrogen, which exerts its effect via oestrogen receptors. The role of oestrogen in breast cancer is well described, and antioestrogen medication such as tamoxifen, which blocks oestrogen receptors are in widespread and effective use. The role of oestrogen receptors in oesophageal cancer however, is less well defined. Work conducted by the investigators, as well as another research group in Australia showed that antioestrogens including tamoxifen, reduce oesophageal cancer cell growth in the laboratory. To date, no studies have assessed the effect of tamoxifen therapy on oesophageal cancer growth in humans. The investigators propose a study to determine the effect of tamoxifen in patients with oesophageal cancer who aren't undergoing surgery or chemotherapy. Patients will receive tamoxifen tablets daily for 4 weeks after which time a biopsy (sample of cancer tissue) will be taken at gastroscopy (a flexible camera that is passed into the mouth through the gullet into the stomach). The biopsy will be compared with the biopsy taken at the time of diagnosis to determine if tamoxifen has had any effect on cancer cell growth. If this study shows that tamoxifen does slow cancer cell growth it could lead to a larger study of patients with oesophageal cancer taking tamoxifen for a longer time period to determine if there is any clinical benefit.
COMplementary Hand-foot Massage to Improve Experience of illneSs Trial
Gastrointestinal CancerThe COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is a prospective, randomized trial and executed at a Western referral Centre: Zuyderland Medical Centre located Sittard-Geleen, The Netherlands concerning patients who underwent surgery for gastrointestinal malignancy. During 5 consecutive days, the intervention group received postoperatively hand-foot massage administered by trained volunteers. The aim of this study is to investigate the effect of complementary therapies concerning quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).
Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery
Postoperative IleusGastrointestinal CancerThe goal of this study is to learn if electro-acupuncture is a feasible treatment option for postoperative ileus after abdominal surgery. The second goal of this study is to evaluate the time to resolution of postoperative ileus after receiving electro-acupuncture treatments.
Kinase Genotyping of Gastro Intestinal Stomach Tumors (GISTs) From Patients Enrolled in Pfizer A6181112...
Gastrointestinal NeoplasmThe purpose of this study is to determine the genetic makeup of gastro intestinal stomach tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be screened for mutations and this information will be used to determine whether the progression-free survival of patients being treated with the cancer medication sunitinib is related to the underlying genotype of their GIST.
Gastrointestinal Anastomosis Using MonoPlus® Suture
Gastrointestinal Stromal TumorsGastrointestinal Neoplasms5 moreThe primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction. This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.
Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery
Gastric CancerPancreatic Cancer2 moreThis study will evaluate the performance of the EnLightTM and LightPathTM Imaging Systems in detecting tumour lesions in patients with gastric, pancreas, bile duct or duodenal cancer. EnLightTM will be used to detect positron emission and the LightPathTM system to detect Cerenkov Luminescence. Both are emitted by the Positron Emission Tomography (PET) agent. The study will also evaluate the patient safety and radiation safety of the EnLightTM, and the safety for the device operators and surgical staff of the LightPathTM Imaging System.