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- Zick et al. (2008): Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting + (No significant difference between the arms.)
- Zick et al. (2008): Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting + (No significant difference between the arms.)
- Thamlikitkul et al. (2017): Efficacy of ginger for prophylaxis of chemotherapy-induced nausea and vomiting in breast cancer patients receiving adriamycin–cyclophosphamide regimen: a randomized, double-blind, placebo-controlled, crossover study + (No significant difference in the incidence of adverse events between subjects receiving ginger and placebo. No study-treatment-related adverse events were observed.)
- Thamlikitkul et al. (2017): Efficacy of ginger for prophylaxis of chemotherapy-induced nausea and vomiting in breast cancer patients receiving adriamycin–cyclophosphamide regimen: a randomized, double-blind, placebo-controlled, crossover study + (No significant difference in the incidence of adverse events between subjects receiving ginger and placebo. No study-treatment-related adverse events were observed.)
- Ehrenpreis et al. (2005): A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Retinol Palmitate (Vitamin A) for Symptomatic Chronic Radiation Proctopathy + (No systematic indication, only one comment in discussion: "No change in liver enzyme testing has occurred in any patients receiving retinol palmitate")
- Rastelli et al. (2011): Vitamin D and aromatase inhibitor-induced musculoskeletal symptoms (AIMSS): a phase II, double-blind, placebo-controlled, randomized trial + (No toxicities or significant adverse events.)
- Rastelli et al. (2011): Vitamin D and aromatase inhibitor-induced musculoskeletal symptoms (AIMSS): a phase II, double-blind, placebo-controlled, randomized trial + (No.)
- Lyckholm et al. (2012): A randomized, placebo controlled trial of oral zinc for chemotherapy-related taste and smell disorders + (Not arm specified: diarrhea, abdominal pain, cramps, diaphoresis)
- Lyckholm et al. (2012): A randomized, placebo controlled trial of oral zinc for chemotherapy-related taste and smell disorders + (Not arm specified: diarrhea, abdominal pain, cramps, diaphoresis)
- Stendell-Hollis et al. (2010): Green tea improves metabolic biomarkers, not weight or body composition: a pilot study in overweight breast cancer survivors + (Not arm specified: intolerance or dislike of tea product (n=4))
- Stendell-Hollis et al. (2010): Green tea improves metabolic biomarkers, not weight or body composition: a pilot study in overweight breast cancer survivors + (Not arm specified: intolerance or dislike of tea product (n=4))
- Olsen et al. (2001): The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy + (Not reported, although no allergic skin reactions to aloe have been documented.)
- Vitale et al. (2020): ZeOxaNMulti Trial: A Randomized, Double-Blinded, Placebo-Controlled Trial of Oral PMA-Zeolite to Prevent Chemotherapy-Induced Side Effects, in Particular, Peripheral Neuropathy + (Not separated between arms Only general indication of good tolerability)
- 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 + (Not separated between arms: Unclear cause … Not separated between arms: </br>Unclear cause: n=13 cystectomy (intervention arm: n=6, placebo arm: n=7), n=23 deceased (intervention arm: n=13, placebo arm: n=10);</br></br>Report of side effects: intervention arm: n=7 and placebo arm: n=10, all grade 1 except n=1, grade 2 pain in the intervention arm; side effects were change in nails, back and neck pain, constipation, sleep disturbances, dizziness, and arthralgia, with one n=1 patient reporting nausea, pain, and stomach problems and another patient dizziness and diarrheaand another patient dizziness and diarrhea)
- 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 + (Not separated between arms: Unclear cause … Not separated between arms: </br>Unclear cause: n=13 cystectomy (intervention arm: n=6, placebo arm: n=7), n=23 deceased (intervention arm: n=13, placebo arm: n=10);</br></br>Report of side effects: intervention arm: n=7 and placebo arm: n=10, all grade 1 except n=1, grade 2 pain in the intervention arm; side effects were change in nails, back and neck pain, constipation, sleep disturbances, dizziness, and arthralgia, with one n=1 patient reporting nausea, pain, and stomach problems and another patient dizziness and diarrheaand another patient dizziness and diarrhea)
- Shapiro et al. (2016): Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) + (Not separated between arms: musculoskeletal (18%) and gastrointestinal (17%), no significant differences)
- Shapiro et al. (2016): Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) + (Not separated between arms: musculoskeletal (18%) and gastrointestinal (17%), no significant differences)
- Kraft et al. (2012): L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN) - a randomized multicentre trial + (Not seperated by arm: Predominantly nausea, vomiting, diarrhea without differences between the arms (p=kA); according to the authors a consequence of chemotherapy)
- Kraft et al. (2012): L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN) - a randomized multicentre trial + (Not seperated by arm: Predominantly nausea, vomiting, diarrhea without differences between the arms (p=kA); according to the authors a consequence of chemotherapy)
- Argyriou et al. (2006): Preventing Paclitaxel-Induced Peripheral neuropathy: A Phase 2 Trial of Vitamin E Supplementation + (Number of side effects (ITT): Intervention arm: 16/18 (88.8%); control arm: 18/19 (94.7%); p = 0.96 (mainly nausea, vomiting and hair loss, no side effects associated with vitamin E, no deaths caused by vitamin E.)
- Minchom et al. (2014): An unblinded, randomised phase II study of platinum-based chemotherapy with vitamin B12 and folic acid supplementation in the treatment of lung cancer with plasma homocysteine blood levels as a biomarker of (...) + (Occurrence of grade 3/4 nausea/vomiting, infections, diarrhea, constipation and nephrotoxicity)
- Minchom et al. (2014): An unblinded, randomised phase II study of platinum-based chemotherapy with vitamin B12 and folic acid supplementation in the treatment of lung cancer with plasma homocysteine blood levels as a biomarker of (...) + (Occurrence of grade 3/4 nausea/vomiting, infections, diarrhea, constipation and nephrotoxicity)
- Howells et al. (2011): Phase I randomised double-blind pilot study of micronized resveratrol (SRT501) in patients with hepatic metastases - safety, pharmacokinetics and pharmacodynamics + (One case of lethargy in the placebo group, which was ongoing at follow-up. One case with diarrhoea.)
- Paur et al. (2017): Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA + (One case of vomiting probably related to the fish oil supplement)
- Puataweepong et. al (2009): The efficacy of oral Aloe vera juice for radiation induced mucositis in head and neck cancer patients: a double-blind placebo-controlled study + (One patient in the placebo arm discontinued the test solution due to unfavorable taste and was reported as a non-compliance.)
- Vitale et al. (2020): ZeOxaNMulti Trial: A Randomized, Double-Blinded, Placebo-Controlled Trial of Oral PMA-Zeolite to Prevent Chemotherapy-Induced Side Effects, in Particular, Peripheral Neuropathy + (Only general indication of good tolerability Not separated between arms)
- 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 + (Overall 64% at least one event; assessed a … Overall 64% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=41 (20.7%), of which somnolence n=6 (3%), dizziness n=6 (3%), nausea n=8 (4%)</br></br></br>2 severe side effects associated with intervention: 1x constipation (with 360mg/day morphine equivalents), 1x moderate disorientation and somnolence on day 4 (with 2.5 daily sprays of Sativex)</br></br></br>None of the deaths related to interventionNone of the deaths related to intervention)
- 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 + (Overall 68% at least one event; assessed a … Overall 68% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: </br>Total n=64 (32.2%), of which somnolence n=18 (9%), dizziness n=15 (7.5%), nausea n=10 (5%)</br></br></br>2 severe side effects associated with intervention: 1x constipation (with 360mg/day morphine equivalents), 1x moderate disorientation and somnolence on day 4 (with 2.5 daily sprays of Sativex)</br></br></br>None of the deaths related to interventionNone of the deaths related to intervention)
- Scher et al. (2011): Randomized, open-label phase III trial of docetaxel plus high-dose calcitriol versus docetaxel plus prednisone for patients with castration-resistant prostate cancer + (Overall adverse events 93.3%, severe adver … Overall adverse events 93.3%, severe adverse events: 33%;</br>highest incidence of adverse events occurred in the gastrointestinal system: 72%, of which nausea, diarrhea, constipation, vomiting, and stomatitis were most frequent,</br>most common severe adverse events: febrile neutropenia 4.6%, pneumonia 2.9%, dehydration 2.7%, disease progression 1.3%, dyspnea 1.1%, deep vein thrombosis 2.5%, 0.6% hypercalcemia, 0.2% hypercalcemia grade ≥ 3ypercalcemia, 0.2% hypercalcemia grade ≥ 3)
- Scher et al. (2011): Randomized, open-label phase III trial of docetaxel plus high-dose calcitriol versus docetaxel plus prednisone for patients with castration-resistant prostate cancer + (Overall adverse events 93.5%, severe adver … Overall adverse events 93.5%, severe adverse events: 35%;</br>highest incidence of adverse events occurred in the gastrointestinal system: 79%, of which nausea, diarrhea, constipation, vomiting, and stomatitis were most frequent,</br>most common severe adverse events: febrile neutropenia 1.0%, pneumonia 3.1%, dehydration 2.5%, disease progression 2.5%, dyspnea 2.1%, deep vein thrombosis 0.6%, 5.9% hypercalcemia, 0.8% hypercalcemia grade ≥ 3ypercalcemia, 0.8% hypercalcemia grade ≥ 3)
- Ryan et al. (2011): Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: a URCC CCOP study of 576 patients + (Overall associated with ginger: gastrointestinal symptoms, such as stage 2 heartburn, bruising/redness and skin rash)
- Ryan et al. (2011): Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: a URCC CCOP study of 576 patients + (Overall associated with ginger: gastrointestinal symptoms, such as stage 2 heartburn, bruising/redness and skin rash)
- Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers + (Pain, fever, weakness, vomiting, itching, swelling, haemoptysis; no difference between the arms (p=kA) Radiation therapy gaps: 9 patients from the Enzyme-arm because of social/technical problems)
- Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers + (Pain, fever, weakness, vomiting, itching, … Pain, fever, weakness, vomiting, itching, swelling, haemoptysis; no difference between the arms (p=kA)</br></br>Radiation therapy gaps: </br>3 gaps because of social/technical problems; in 2 patients in the control-arm, radiation had to be temporarily discontinued due to severe radiation therapy-related reactionssevere radiation therapy-related reactions)
- 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 + (Part A Overall 60% at least one event, as … Part A</br></br>Overall 60% at least one event, assessed as probably intervention-associated with frequency ≥ 5%: Total n=128, 31.7%, somnolence (n=42, 10.4%), nausea (n=21, 5.2%) and dizziness (n=21, 5.2%)</br></br>Part B</br></br>Overall 72% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=16, 15.5%; somnolence (n=6, 5.8%)</br></br></br>More than twice as many patients in Sativex arm discontinued study due to side effects (n=14, 13.6% vs. n=6, 5.8%); no statistical comparison given)</br></br>None of the deaths related to interventionNone of the deaths related to intervention)
- Togni et al. (2015): Clinical evaluation of safety and efficacy of Boswellia-based cream for prevention of adjuvant radiotherapy skin damage in mammary carcinoma: a randomized placebo controlled trial + (Patients report non-absorption of residues; typical and characteristic odor of the cream was reported as pleasant or too intense.)
- Crew et al. (2012): Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer + (Recording with CTCAE Side effects in all P … Recording with CTCAE</br>Side effects in all Poly E arms: number of patients in n (%)</br>Nausea: 8 (27)</br>Diarrhoea: 3 (10)</br>Constipation: 3 (10)</br>Indigestion: 10 (33)</br>Abdominal pain: 1 (3)</br>Flatulence: 1 (3)</br>Gastrointestinal haemorrhage: 1 (3)</br>Weight gain: 1 (3)</br>Palpitations: 1 (3)</br>Elevated transaminases: 3 (10)</br>Elevated alkaline phosphatase: 2 (7)</br>Elevated lipase: 2 (7)</br>Elevated uric acid: 1 (3)</br>Proteinuria: 3 (10)</br>Anaemia: 2 (7)</br>Headache: 2 (7)</br>Insomnia: 4 (13)</br>Irregular menstruation: 1 (3)</br>Hot flushes: 1 (3)lar menstruation: 1 (3) Hot flushes: 1 (3))
- Crew et al. (2012): Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer + (Recording with CTCAE Side effects in all P … Recording with CTCAE</br>Side effects in all Poly E arms: number of patients in n (%)</br>Nausea: 8 (27)</br>Diarrhoea: 3 (10)</br>Constipation: 3 (10)</br>Indigestion: 10 (33)</br>Abdominal pain: 1 (3)</br>Flatulence: 1 (3)</br>Gastrointestinal haemorrhage: 1 (3)</br>Weight gain: 1 (3)</br>Palpitations: 1 (3)</br>Elevated transaminases: 3 (10)</br>Elevated alkaline phosphatase: 2 (7)</br>Elevated lipase: 2 (7)</br>Elevated uric acid: 1 (3)</br>Proteinuria: 3 (10)</br>Anaemia: 2 (7)</br>Headache: 2 (7)</br>Insomnia: 4 (13)</br>Irregular menstruation: 1 (3)</br>Hot flushes: 1 (3)lar menstruation: 1 (3) Hot flushes: 1 (3))
- Crew et al. (2012): Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer + (Recording with CTCAE Side effects in all P … Recording with CTCAE</br>Side effects in all Poly E arms: number of patients in n (%)</br>Nausea: 8 (27)</br>Diarrhoea: 3 (10)</br>Constipation: 3 (10)</br>Indigestion: 10 (33)</br>Abdominal pain: 1 (3)</br>Flatulence: 1 (3)</br>Gastrointestinal haemorrhage: 1 (3)</br>Weight gain: 1 (3)</br>Palpitations: 1 (3)</br>Elevated transaminases: 3 (10)</br>Elevated alkaline phosphatase: 2 (7)</br>Elevated lipase: 2 (7)</br>Elevated uric acid: 1 (3)</br>Proteinuria: 3 (10)</br>Anaemia: 2 (7)</br>Headache: 2 (7)</br>Insomnia: 4 (13)</br>Irregular menstruation: 1 (3)</br>Hot flushes: 1 (3)lar menstruation: 1 (3) Hot flushes: 1 (3))
- Crew et al. (2012): Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer + (Recording with CTCAE Side effects in place … Recording with CTCAE</br>Side effects in placebo arm: number of patients in n (%)</br>Nausea: 2 (20)</br>Diarrhoea: 2 (20)</br>Indigestion: 2 (20)</br>Abdominal pain: 2 (20)</br>Flatulence: 1 (10)</br>Palpitations: 1 (10)</br>Shortness of breath: 1 (10)</br>Cough: 1 (10)</br>Elevated bilirubin: 1 (10)</br>Elevated uric acid: 1 (10)</br>Proteinuria: 1 (10)</br>Headache: 2 (20)</br>Confusion: 1 (10)</br>Irregular menstruation: 1 (10)</br>Flushing: 1 (10)</br>Vaginal discomfort: 1 (10)lushing: 1 (10) Vaginal discomfort: 1 (10))
- Dale et al. (2001): Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects + (Side effects observed were not discriminat … Side effects observed were not discriminated between being radiation therapy-induced or possibly being related to the test drug; gastrointestinal complaints can be possible side effects; in the enzyme-arm fewer complaints tended to be recorded (11.7% vs. 31.6%; p=0.12, ns.)be recorded (11.7% vs. 31.6%; p=0.12, ns.))
- Dale et al. (2001): Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects + (Side effects observed were not discriminated between being radiation therapy-induced or possibly being related to the test drug.)
- Khodabakhshi et al. (2019): Feasibility, Safety, and Beneficial Effects of MCT-Based Ketogenic Diet for Breast Cancer Treatment: A Randomized Controlled Trial Study + (Significant weight loss; according to authors, no serious complications observed)
- Hoopfer et al. (2015): Three-arm randomized phase III trial: Quality aloe and placebo cream versus powder as skin treatment during breast cancer radiation therapy + (Skin rash occurred in all 3 arms, with the highest reported incidence in aloe cream (aloe cream 30.9%; placebo cream 15.6%; powder 5.1%).)
- Hoopfer et al. (2015): Three-arm randomized phase III trial: Quality aloe and placebo cream versus powder as skin treatment during breast cancer radiation therapy + (Skin rash occurred in all 3 arms, with the highest reported incidence in aloe cream (aloe cream 30.9%; placebo cream 15.6%; powder 5.1%).)
- Hoopfer et al. (2015): Three-arm randomized phase III trial: Quality aloe and placebo cream versus powder as skin treatment during breast cancer radiation therapy + (Skin rash occurred in all 3 arms, with the highest reported incidence in aloe cream (aloe cream 30.9%; placebo cream 15.6%; powder 5.1%).)
- Toma et al. (2003): β-carotene supplementation in patients radically treated for stage I-II head and neck cancer: Results of a randomized trial + (Skin toxicity (N = 4), mucositis (N = 1))
- Lissoni et al. (1998): Biotherapy with the Pineal Immunomodulating Hormone Melatonin versus Melatonin plus Aloe vera in Untreatable Advanced Solid Neoplasms + (Some patients had diarrhoea when they started taking the aloe tincture, but this subsided after the first few days. Melatonin was well tolerated, no related toxicities.)
- Kessels et al. (2017): Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma A Randomized Clinical Trial + (Survey by doctor and weekly diary entries … Survey by doctor and weekly diary entries by patients</br></br>Side effects in the placebo arm after 3/6/8 weeks in %:</br>Erythema: 6/2/2</br>Edema: 0/0/0</br>Erosion: 1/0/0</br>Crusts: 2/0/0 </br>Vesicles/Bullae: 0/1/0 </br>Squamae:0/0/0 </br>Itching: 3/0/1 </br>Burning Sensation: 1/1/0</br></br>Use of the sinecatechins ointment led to a statistically significant higher frequency of erythema, edema,erosions, crusts, and itching than the use of placebo ointment. itching than the use of placebo ointment.)
- Kessels et al. (2017): Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma A Randomized Clinical Trial + (Survey by doctor and weekly diary entries … Survey by doctor and weekly diary entries by patients</br>Side effects in the sinecatechins arm after 3/6/8 weeks in %:</br>Erythema: 10/12/9</br>Edema: 2/6/3</br>Erosion: 5/7/4</br>Crusts: 3/10/6</br>Vesicles/Bullae: 3/3/2</br>Squamae:3/5/4</br>Itching: 10/13/12</br>Burning Sensation: 3/5/3</br></br>Use of the sinecatechins ointment led to a statistically significant higher frequency of erythema, edema, erosions, crusts, and itching than the use of placebo ointment. itching than the use of placebo ointment.)
- Nguyen et al. (2012): Randomized, Double-Blind, Placebo-Controlled Trial of Polyphenon E in Prostate Cancer Patients before Prostatectomy: Evaluation of Potential Chemopreventive Activities + (The NCI Common Terminology Criteria for Ad … The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and diary were used for adverse event description and grading; side effects were all grade I or II; Summary of adverse events occurring in greater than 4% of subjects treated with polyphenon E or placebo, regardless of attribution</br></br>Polyphenon E (N = 25), n (%)</br>Nausea: 4 (16) </br>Diarrhea: 2 (8)</br>Headache: 1 (4): 4 (16) Diarrhea: 2 (8) Headache: 1 (4))