External application for reduction of fatigue and improvement of quality of life in patients with metastasised tumor diseases undergoing palliative radiotherapy. A randomized controlled trial

Not Applicable

• Conditions: patients with metastasied tumor diseases (bone or brain metastases) during 2 week inpatient palliative radiotherapy (bone or brain radiation)

• Registration Number: DRKS00012999
• Lead Sponsor: Charité Universitätsmedizin BerlinKlinik für Radioonkologie und Strahlentherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-16
• Study Completion: 2019-09-30
• Results First Posted: 2021-04-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Minor fatigue according to MFI (Multidimensional Fatigue Inventory)
life expactancy > 3 month
Karnofsky Index >= 60
indication for palliative whole brain irradiation or bone irradiation
writen consent in study participation and data handling

Exclusion Criteria

Major psychiatric (pre-)condition;
known allergy against used substances;
medical conditions that can cause fatigue, such as untreated hypothyreosis, sleeping apnoe, insomnia, anemia with Hb<8 g/dl, cachexia with BMI< 20, chronic renal failure, acute depression;
other indispositions, skin conditions and medical conditions that can compromise the treatment according to study protocol;
participation in other trials when interfering with this study;
multiple liver metastasis (could cause pain during the application)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue; Multidimensional Fatigue Inventory – German version (MFI) (Schwarz, Krauss, & Hinz, 2003; Smets, Garssen, Bonke, & De Haes, 1995);<br>time of measurement: before intervention, after intervention period and follow up two weeks after end of intervention period

Secondary Outcome Measures

Name	Time	Method
Health related QoL; European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-C30) (Aaronson et al., 1993). <br>psychosocial distress; NCCN Distress-Thermometer, German version (Mehnert, Müller, Lehmann, & Koch, 2006).<br>time of measurement: before intervention, after intervention period and follow up two weeks after end of intervention period.<br><br>Physiological outcomes: <br>- heart rate variability (HRV), time of measurement: before intervention, after intervention period <br>- body core temperature, measured before and after every single application<br>Qualitative analysis of the intervention:<br>- visual analog scales (VAS) for mood, relaxation, fatigue; measured before and after every single application<br>- problem centered interviews to capture the patientens perspective on the intervention; at the end of the two week intervention period.