Property:Side Effects / Interactions
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C
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 placebo arm: number of patients in n (%)
Nausea: 2 (20)
Diarrhoea: 2 (20)
Indigestion: 2 (20)
Abdominal pain: 2 (20)
Flatulence: 1 (10)
Palpitations: 1 (10)
Shortness of breath: 1 (10)
Cough: 1 (10)
Elevated bilirubin: 1 (10)
Elevated uric acid: 1 (10)
Proteinuria: 1 (10)
Headache: 2 (20)
Confusion: 1 (10)
Irregular menstruation: 1 (10)
Flushing: 1 (10)
Vaginal discomfort: 1 (10) +
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 Poly E arms: number of patients in n (%)
Nausea: 8 (27)
Diarrhoea: 3 (10)
Constipation: 3 (10)
Indigestion: 10 (33)
Abdominal pain: 1 (3)
Flatulence: 1 (3)
Gastrointestinal haemorrhage: 1 (3)
Weight gain: 1 (3)
Palpitations: 1 (3)
Elevated transaminases: 3 (10)
Elevated alkaline phosphatase: 2 (7)
Elevated lipase: 2 (7)
Elevated uric acid: 1 (3)
Proteinuria: 3 (10)
Anaemia: 2 (7)
Headache: 2 (7)
Insomnia: 4 (13)
Irregular 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 Poly E arms: number of patients in n (%)
Nausea: 8 (27)
Diarrhoea: 3 (10)
Constipation: 3 (10)
Indigestion: 10 (33)
Abdominal pain: 1 (3)
Flatulence: 1 (3)
Gastrointestinal haemorrhage: 1 (3)
Weight gain: 1 (3)
Palpitations: 1 (3)
Elevated transaminases: 3 (10)
Elevated alkaline phosphatase: 2 (7)
Elevated lipase: 2 (7)
Elevated uric acid: 1 (3)
Proteinuria: 3 (10)
Anaemia: 2 (7)
Headache: 2 (7)
Insomnia: 4 (13)
Irregular menstruation: 1 (3)
Hot flushes: 1 (3) +
Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study +
1 case of constipation and 1 case of diarrhea were reported by the authors to be associated with carnitine +
Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study +
NI +
Cruciani et al. (2012): L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial +
No group differences between side effect grade 5 (Fisher's exact p=0.64)
One death possibly caused by treatment (arm unclear).
Otherwise possibly/probably/definitely treatment related:
Hemoglobin: 9x, Platelets: 2x, Death due to disease progression: 2x, Anorexia: 1x, Diarrhea: 4x, Dizziness: 4x, Vomiting: 2x, Abdominal pain: 2x, Atrial fibrillation: 1x, Stench: 1x, Extrapyramidal symptoms: 1x
By “treatment associated”, probably chemo-/radiotherapy meant. However, description not clear. +
Cruciani et al. (2012): L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial +
No group differences between side effect grade 5 (Fisher's exact p=0.64)
One death possibly caused by treatment (arm unclear).
Otherwise possibly/probably/definitely treatment related:
Hemoglobin: 10x, Fatigue: 2x, Itching: 1x, Rash: 1x, Constipation: 1x, Diarrhea: 1x, Dizziness: 4x, Vomiting: 1x, Infection reason unknown: 1x, Genitourinary tract: 1x, Abdominal pain: 1x, Dyspnea: 2x
By “treatment associated”, probably chemo-/radiotherapy meant. However, description not clear. +
Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial +
No differences for sleepiness (p=0.32), anxiety (p=0.92) and xerostomia (p=0.83) +
Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial +
No differences for sleepiness (p=0.32), anxiety (p=0.92) and xerostomia (p=0.83) +
D
Da Costa et al. (2009): Effectiveness of Guarana (Paullinia cupana) for Postradiation Fatigue and Depression Results of a Pilot Double-Blind Randomized Study +
NI +
Da Costa et al. (2009): Effectiveness of Guarana (Paullinia cupana) for Postradiation Fatigue and Depression Results of a Pilot Double-Blind Randomized Study +
NI +
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; 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.) +
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. +
Dardano et al. (2012): The effect of Ginkgo biloba extract on genotoxic damage in patients with differentiated thyroid carcinoma receiving thyroid remnant ablation with Iodine-131 +
No clinically relevant side effects. +
Dardano et al. (2012): The effect of Ginkgo biloba extract on genotoxic damage in patients with differentiated thyroid carcinoma receiving thyroid remnant ablation with Iodine-131 +
No clinically relevant side effects. +
Del Giglio (2013): Purified Dry Extract of Paullinia cupana (Guarana) (PC-18) for Chemotherapy-Related Fatigue in Patients with Solid Tumors: An Early Discontinuation Study +
NI +
Del Giglio (2013): Purified Dry Extract of Paullinia cupana (Guarana) (PC-18) for Chemotherapy-Related Fatigue in Patients with Solid Tumors: An Early Discontinuation Study +
NI +
Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis +
Discomfort (including hot flushes, nausea, asthenia, headaches, dizziness) in n=0 +
Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis +
Discomfort (including hot flushes, nausea, asthenia, headaches, dizziness) in n=2 +
Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis +
Discomfort (including hot flushes, nausea, asthenia, headaches, dizziness) in n=4 +