Property:Exclusion criteria
This is a property of type Text.
D
Karnofsky index < 50%; known intolerance to enzyme preparations or additives; women declining to perform a pregnancy test (HCG method) before start of the study; pregnancy or lactation; participation in another clinical study within the previous 30 days; concurrent participation in another clinical study +
E
Ehrenpreis et al. (2005): A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Retinol Palmitate (Vitamin A) for Symptomatic Chronic Radiation Proctopathy +
- Hemoglobin level at the time of enrollment < 10 gm/dl or if patients had received two or more units of packed red blood cells as treatment for anemia
- Patients with rectal ulcerations, strictures, or fistulization
- Patients with clinicallysignificant liver disease +
Emami et al. (2014): Double-blinded, randomized, placebo-controlled study to evaluate the effectiveness of green tea in preventing acute gastrointestinal complications due to radiotherapy +
Patients with past history of irradiation; diarrhea before the beginning of pelvic irradiation, taking another drug for treatment of diarrhea during the study, unwilling to participate in the study at any time +
Ertekin et al. (2004): Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study +
Previous history of autoimmune or chronic inflammatory disease, radiotherapy and cytotoxic chemotherapy had previously been administered, use of medicine with the aim of mucositis prophylaxis, less than one-third of buccal mucosa was in the radiotherapy region, patient refused entry +
F
Fahimi et al. (2011): Evaluating the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens +
Clinical evidence of current or impending bowel obstruction, current radiotherapy, that is classified as high or intermediate risk of causing nausea and vomiting; pregnancy or lactation, concurrent use of ginger products +
Fallahi et al. (2013): Does vitamin E protect salivary glands from I-131 radiation damage in patients with thyroid cancer? +
Patients with xerostomia, previous salivary gland dysfunction, salivary stone or tumor, those who had undergone head and neck radiotherapy previously, who had known rheumatological diseases such as Sjögren’s disease, who had been administered <sup>131</sup>I earlier, who had known liver disease, had taken drugs influencing salivary gland function, such as antihistaminic agents, beta-blockers, atropine, benzodiazepines, tricyclic antidepressants, and antipsychotic drugs in the past 2 weeks +
Fallon et al. (2017) I: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
Baseline use of morphine at > 500 mg morphine equivalents/day (inclusive of maintenance and breakthrough opioids); current use of more than one type of breakthrough opioid analgesic; planned clinical interventions that would affect pain; any history of schizophrenia or substance abuse including recreational use of cannabis product +
Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
Baseline use of morphine at >500mg morphine equivalents/day (inclusive of maintenance and breakthrough opioids); current use of more than one type of breakthrough opioid analgesic; planned clinical interventions that would affect pain; any
history of schizophrenia or substance abuse including recreational use of cannabis product +
Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial +
(5) no trismus, concomitant use of oral anticoagulants, previous or current history of other cancers, previous history of RT in the head and neck area, or previous or concomitant chemotherapy +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
25-OHD >50 nmol/L, hypercalcemia during the past two months; eGFR<30 mL/h; a medical history of kidney stones, sarcoidosis and/or primary hyperparathyroidism; current medication including vitamin D >400 IU/day, digoxin/digitoxin or thiazides; hypersensitivity to the study drug; participation in other clinical trials involving medication; or other reasons for not being able to complete the planned procedures +
Freedland et al. (2020): A Randomized Controlled Trial of a 6-month low carbohydrate intervention on disease progression in men with recurrent prostate cancer: Carbohydrate and Prostate Study 2 (CAPS2) +
Symptomatic metastatic disease; anticipation of needing secondary prostate cancer therapy within the next 6 months; current use of weight loss medications or enrollment in a diet/weight loss program; current therapy aimed at lowering testosterone levels (including GnRH agonist/antagonist; prior bilateral orchiectomy; oral anti-androgens, or 5-alpha reductase inhibitors; testosterone replacement was allowed but treatment should be stable during the entire study); already consuming an low carbohydrate diet; being vegetarian/vegan; weight loss >5% of body weight in the last 6 months based on self-report; medical comorbidities that in the opinion of the investigator limits the patient’s ability to complete the study +
G
Ghoreishi et al. (2007): Effect of vitamin E on chemotherapy-induced mucositis and neutropenia in leukemic patients undergoing bone marrow transplantation +
NI +
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial +
History of any type of malignancy within the past 5 years and other serious medical or psychiatric illness that would preclude giving informed consent +
Gorgu et al. (2013): The effect of zinc sulphate in the prevention of radiation induced oral mucositis in patents with head and neck cancer +
NI +
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial +
Eastern Cooperative Oncology Group (ECOG) performance status of >2; a contraindication to medicinal cannabis such as unstable cardiovascular disease, substance use disorder, or significant mental health disorder; experiencing disease-related nausea and vomiting; receiving concomitant oral chemotherapy; had received/were planned to receive radiotherapy to the brain or gastrointestinal tract during the study period +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
Prior radiation therapy; patients with distant metastasis, Kornovsky Index <70; altered hematological or biochemical parameters +
H
Hajimohammadebrahim-Ketabforoush et al. (2019): Effect of Vitamin D Supplementation on Postcraniotomy Pain After Brain Tumor Surgery: A Randomized Clinical Trial +
Having another trial participation session, including previous participation in the pilot trial, pregnant or lactating women, hypercalcemia, hyperphosphatemia, tuberculosis, sarcoidosis, history of nephrolithiasis, history of hyperparathyroidism, medications interfering with vitamin D metabolism, renal insufficiency, patients having psychological diseases, abnormal mental function, and unconscious patients +
Halyard et al. (2007): Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4) +
Known mechanical obstruction of the alimentary tract; malabsorption, or intractable vomiting; previous surgery that had included ablation or removal of the olfactory component of taste; known intolerance to zinc sulfate; or untreated oral thrush; women who were pregnant, nursing, or of childbearing potential and unwilling to use contraception +
Heggie et al. (2002): A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue +
Self-reported allergy to aloe vera; breast infection; indication for nodal irradiation +
Hejazi et al. (2013): A pilot clinical trial of radioprotective effects of curcumin supplementation in patients with prostate cancer +
Clinical stage T3 or T4, Gleason score ≥ 8, serum PSA ≥ 20 ng/mL, other prior surgery for prostate cancer, concurrent participation in another clinical trial which would require approval upon entry to this trial, gastrointestinal disorders such as inflammatory bowel disease, reflux and peptic ulcers and any adverse reaction to curcumin +