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Property:Dosage and regime

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F
Week 1: dose finding; week 2-5: stable dose, max. 10 sprays * Part A: first week average number of sprays: 3.6, second week: 6.4 * Part B: average daily number: 6.3  +
Sativex® (nabiximol, THC 27 mg/mL, CBD 25 mg/mL) via oral spray (self-applied by patient); week 1: dose finding; week 2-5: stable dose, max. 10 sprays * Part A: first week average number of sprays: 3.6; second week: 6.4 * Part B: average daily number: 6.5  +
Oral 400mg twice daily (immediately before radiotherapy and 8-12 hours after) Start: Day 0 radiotherapy Duration: entire radiotherapy  +
Oral 500mg twice daily (immediately before radiotherapy and 8-12 hours after) Start: Day 0 radiotherapy Duration: entire radiotherapy  +
Low-carbohydrate diet with ≤20g carbohydrates per day Supervision by dietician by telephone weekly in the first 3 months and then every 2 weeks in the last 3 months  +
G
1-4 capsules (each THC 2.5mg/CBD 2.5mg) 3x daily from one day before chemotherapy to day 5; median (SD) number of capsules: 2 (1-3)  +
3x3 tablets WOBE-MUGOS E (10mg papain, 40mg trypsin, 40mg chymotrypsin) daily, starting 3 days before the first radiotherapy treatment over a period of 54(+/-9) days until 5 days after completion of radiation therapy + all patients received 50 to 70 Gy telecobalt therapy using a standard daily radiation dose of 2 Gy in 25-35 fractions over a period of 6-7 weeks  +
+ all patients received 50 to 70 Gy telecobalt therapy using a standard daily radiation dose of 2 Gy in 25-35 fractions over a period of 6-7 weeks  +
H
All participants: pain medication, including intravenous injection of apotel 1 g, morphine sulfate 3 mg, and oral acet-aminophen 500 mg, depending on each patient’s need in the intensive care unit and ward  +