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- 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))
- 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 participant diary were used to 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>Placebo (N = 25), n (%)</br>Nausea: 4 (16) </br>Diarrhea: 5 (20) </br>Headache: 2 (8) </br>Fever: 3 (12) </br>Body ache: 2 (8) </br>Muscle ache: 2 (8)(12) Body ache: 2 (8) Muscle ache: 2 (8))
- Stratton et al. (2010): Oral Selenium Supplementation Has No Effect on Prostate- Specific Antigen Velocity in Men Undergoing Active Surveillance for Localized Prostate Cancer + (The incidences of brittle hair and brittle … The incidences of brittle hair and brittle nail (grade 1 or 2 and possibly, probably, or definitely related to the intervention) were 6 (12.8%) and the incidences of garlic breath and liver/kidney function test abnormalities (grade 1 and possibly, probably, or definitely related to the intervention) were 0 (0.0%), no significant difference between arms%), no significant difference between arms)
- Stratton et al. (2010): Oral Selenium Supplementation Has No Effect on Prostate- Specific Antigen Velocity in Men Undergoing Active Surveillance for Localized Prostate Cancer + (The incidences of brittle hair and brittle … The incidences of brittle hair and brittle nail (grade 1 or 2 and possibly, probably, or definitely related to the intervention) were 10 (21.7%) and the incidences of garlic breath and liver/kidney function test abnormalities (grade 1 and possibly, probably, or definitely related to the intervention) were 5 (10.9%), no significant difference between arms%), no significant difference between arms)
- Stratton et al. (2010): Oral Selenium Supplementation Has No Effect on Prostate- Specific Antigen Velocity in Men Undergoing Active Surveillance for Localized Prostate Cancer + (The incidences of brittle hair and brittle … The incidences of brittle hair and brittle nail (grade 1 or 2 and possibly, probably, or definitely related to the intervention) were 8 (17.0%) and the incidences of garlic breath and liver/kidney function test abnormalities (grade 1 and possibly, probably, or definitely related to the intervention) were 4 (8.5%); no significant difference between the armsno significant difference between the arms)
- Martin et al. (2002): Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial + (There is a trend towards less need for additional medication in the placebo group.)
- Strasser et al. (2006): Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…) + (Total adverse events: * n=238, of which po … Total adverse events:</br>* n=238, of which possibly intervention-associated n=28 and likely intervention-associated n=9</br>* Temporary or permanent dose reduction was necessary for 34 patients </br>* Adverse events that occurred more than 10 times were: Nausea/vomiting (n=23), fatigue (n=16), pain (n=11), anemia (n=9), dizziness (n=9), dyspnea (n=9), diarrhea (n=6), obstipation (n=6), vertigo (n not reported); no differences in frequencies between arms</br>* Of all side effects n=104 were mild, n=113 moderate, n=21 severe (mainly dizziness, nausea/vomiting, dyspnea)</br>* 32 very severe side effects such as dyspnoea, tumor progression, vomiting, deterioration of general well-being, death, pain, fever, diarrhoea, exsiccation; 6 of which were life-threatening, 25 required hospitalizatione-threatening, 25 required hospitalization)
- Strasser et al. (2006): Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…) + (Total adverse events: * n=197, of which p … Total adverse events: </br>* n=197, of which possibly intervention-associated n=45 and likely intervention-associated n=7</br>* Temporary or permanent dose reduction was necessary for 30 patients </br>* Adverse events that occurred more than 10 times were: Nausea/vomiting (n=21), fatigue (n=14), pain (n=17), anemia (n=14), dizziness (n=11), dyspnea (n=7), diarrhea (n=7), obstipation (n=7), vertigo (n not reported); no differences in frequencies between arm</br>* Of all side effects n=101 were mild, n=71 moderate, n=24 severe (mainly dizziness, nausea/vomiting, dyspnea)</br>* 33 very severe side effects such as dyspnoea, tumor progression, vomiting, deterioration of general well-being, death, pain, fever, diarrhoea, exsiccation; 6 of which were life-threatening, 27 required hospitalizatione-threatening, 27 required hospitalization)
- Strasser et al. (2006): Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…) + (Total adverse events: * n=91, of which po … Total adverse events: </br>* n=91, of which possibly intervention-associated n=17 and likely intervention-associated n=4</br>* Temporary or permanent dose reduction was necessary for 14 patients </br>* Adverse events that occurred more than 10 times were: Nausea/vomiting (n=11), fatigue (n=4), pain (n=5), anemia (n=6), dizziness (n=7), dyspnea (n=2), diarrhea (n=2), obstipation (n=2), vertigo (n not reported); no differences in frequencies between arms</br>* Of all side effects n=36 were mild, n=43 moderate, n=12 severe (mainly dizziness, nausea/vomiting, dyspnea)</br>* 17 very severe side effects such as dyspnoea, tumor progression, vomiting, deterioration of general well-being, death, pain, fever, diarrhoea, exsiccation; 1 of which were life-threatening, 16 required hospitalizatione-threatening, 16 required hospitalization)
- Wrbka et al. (1987): Unterstützung der Chemotherapie inoperabler Karzinome durch proteolytische Fermente + (Treatment with Wobe Mugos E: Tolerance of … Treatment with Wobe Mugos E: </br>Tolerance of microclysms (67 patients in the evaluation): 87.3% of patients with good tolerance, 4 patients with sphincter weakness and limited ability to administer, 12.7% of patients with discontinuation due to gastrointestinal side effects</br></br>Tolerance of dragées (58 patients in the evaluation): 71.4% of patients with good tolerance, 28.6% of patients with discontinuation; in 27% of patients, intake could not be assessed due to unauthorised discontinuation or incorrect information</br></br>Tolerance of local intrapleural application (33 patients in the evaluation): 96.9% of patients with good tolerance, 3.1% of patients with discontinuationnce, 3.1% of patients with discontinuation)
- Sahebjamee et al. (2015): Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial + (Two patients (15.4%) in the aloe arm experienced nausea.)
- Van Zandwijk et al. (2000): EUROSCAN, a Randomized Trial of Vitamin A and N-Acetylcysteine in Patients With Head and Neck Cancer or Lung Cancer + (Typical: mucocutaneous side effects (dryne … Typical: mucocutaneous side effects (dryness, desquamation, itching, bleeding, hair loss)</br></br>Severe side effects (grade 3/4)</br>- Gastrointestinal: 32 </br>- Skin: 50 </br>- Malaise: 5 </br>- Temporary increase in liver enzymes: 2</br>- Hypercholesterolemia: 2</br>- Bone pain: 2</br>- Other: 15lesterolemia: 2 - Bone pain: 2 - Other: 15)
- Van Zandwijk et al. (2000): EUROSCAN, a Randomized Trial of Vitamin A and N-Acetylcysteine in Patients With Head and Neck Cancer or Lung Cancer + (Typical: mucocutaneous side effects (dryne … Typical: mucocutaneous side effects (dryness, desquamation, itching, bleeding, hair loss), symptoms of the digestive tract (especially dyspepsia)</br></br>Severe side effects (grade 3/4)</br>- Gastrointestinal: 47</br>- Skin: 43</br>- Malaise: 1</br>- Temporary increase in liver enzymes: 3</br>- Hypercholesterolemia 3</br>- Bone pain 2</br>- Other: 8cholesterolemia 3 - Bone pain 2 - Other: 8)
- Van Zandwijk et al. (2000): EUROSCAN, a Randomized Trial of Vitamin A and N-Acetylcysteine in Patients With Head and Neck Cancer or Lung Cancer + (Typical: symptoms of the digestive tract (especially dyspepsia) Severe side effects (grade 3/4) - Gastrointestinal: 44 - Skin: 11 - Malaise: 2 - Temporary increase in liver enzymes: 1 - Other: 3)
- Karp et al. (2012): Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597 + (Unclear association, but in long-term follow-up: n=26 in intervention arm had a diabetes diagnosis)
- Karp et al. (2012): Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597 + (Unclear association, but in long-term follow-up: n=12 in placebo arm had a diabetes diagnosis)
- Lua et al. (2015): Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer + (Very mild dizziness or light-headedness on day-5 of aromatherapy treatment n= 1)
- Salihah et al. (2016): The effectiveness of inhaled ginger essential oil in improving dietary intake in breast-cancer patients experiencing chemotherapy-induced nausea and vomiting + (Very mild dizziness or light-headedness on day-5 of aromatherapy treatment n= 1)
- Nasser et al. (2017): Vitamin D ointment for prevention of radiation dermatitis in breast cancer patients + (Vitamin D was well tolerated by patients with no localized or systemic allergic reactions.)
- Nasser et al. (2017): Vitamin D ointment for prevention of radiation dermatitis in breast cancer patients + (Vitamin D was well tolerated by patients with no localized or systemic allergic reactions.)
- Sangthawan et al. (2015): Effects of zinc sulfate supplementation on cell-mediated immune response in head and neck cancer patients treated with radiation therapy + (Vomiting)
- Sangthawan et al. (2015): Effects of zinc sulfate supplementation on cell-mediated immune response in head and neck cancer patients treated with radiation therapy + (Vomiting)
- 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) + (Weight loss; moderate nausea; diarrhea, constipation, headache, fatigue, feeling of weakness (asthenia))
- Jyothirmayi et al. (1996): Efficacy of Vitamin A in the Prevention of Locoregional Recurrence and Second Primaries in Head and Neck Cancer + (dryness of the tongue (n=2), not a drop-out reason)
- 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 + (itching, burning and epidermal changes: 49,2 %)
- Jacot et al. (2016): Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study + (n=1 hypercalciuria)
- Jacot et al. (2016): Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study + (n=1 hypercalciuria)
- Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial + (n=1 renal failure, n=2 mild hypercalcemia, n=1 gastrointestinal symptoms (mild diarrhea, nausea and abdominal pain), n=1 shortness of breath)
- Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial + (n=2 mild hypercalcemia, n=2 gastrointestinal symptoms (mild diarrhea, nausea and abdominal pain), n=1 elevated creatine level)
- Urashima et al. (2019): Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers The AMATERASU Randomized Clinical Trial + (n=3 fractures (1.3%), n=2 urinary stones (0.9%); no patients developed hypercalcemia during the follow-up period)
- Urashima et al. (2019): Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers The AMATERASU Randomized Clinical Trial + (n=5 fractures (3.4%); no patients developed hypercalcemia during the follow-up period)