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Property:Results during intervention

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C
Adverse events were observed in 21 out of 29 patients (hospice patients); 7 were hospitalized (intervention arm: 4 times, placebo arm: 3 times). Fifteen hospice patients and eight non-hospice patients reported adverse events, including: Nausea/vomiting (intervention arm: 2 times); Stomach problems (intervention arm: 2 times); Increased pain (placebo arm: 2 times); Diarrhea (intervention arm: 2 times); Confusion (placebo arm: 1 time); Tinnitus (placebo arm: 1 time) According to the authors, only one case of constipation and one case of diarrhea were associated with carnitine.  +
After 4 weeks: significant difference between arms, with higher proportion of carnitine deficit in placebo arm (intervention arm: 11%, placebo arm: 33%; p≤.001)  +
From Baseline to 8 weeks: improvement in fatigue in intervention arm: Mean difference= -0.96; 95% CI: -1.32,-0.60 and placebo arm: Mean difference= -1.11; 95% CI: -1.44,-0.78; no group difference (z-transformed difference= -0.58; p=0.57)  +
Over the course of the intervention and after: no differences for mood (p=0.3214) and sleep quality (p=0.4438) between arms  +
Over the course of the intervention and after: no differences for pain (p=0.6048), analgesic use (p=0.6671), no delay in time to 20% pain increase (p=0.4614) between arms  +
No difference between arms (p=0.4270), even after controlling for tumor site, treatment method and cancer stage at week 7 or the entire study period  +
Over the course of the intervention and after: no difference for nausea (p=0.7105) or antiemetic consumption (p=0.6124) between arms  +
Over the course of the intervention and after: no difference for weight fluctuations (p=0.1454) or need for a feeding tube (no p-value) between arms.  +
D
In both arms most of the patients showed only a slight increase of frequency of stools, change in the quality of bowel habits and rectal discomfort. 31.6% of the control-arm was observed to have diarrhoea. 11.7% in the enzyme-arm showed similar symptoms. 6 patients (3 per arm) showed bloody stools, perforations and fistulae.  +
78.3% of the enzyme arm showed no skin reactions or faint erythema. 40.0% of the control-arm showed moderate to bright erythema or patchy moist desquamation. 15% of the control-arm showed confluent moist desquamation and pitting oedema. 5% of the enyzme-arm showed the same symptoms. 1 patient (control-arm) showed frank skinulceration.  +
During radiation therapy patients initially exhibited patchy vaginal mucositis which gradually progressed to confluent fibrous mucositis. 41.6% of both arms experienced mild pain. 16.6% of the control-arm exhibited patchy mucositis with serosanguineuos discharge. They also experienced moderate pain requiring the use of analgesics. 6.6% of the enzyme arm showed similar signs and symptoms.  +