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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

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 - fatigue study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012999
Enrollment
70
Registered
2019-05-16
Start date
2017-09-11
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Group 1: over a course of two weeks daily application of a hepatic compress with yarrow at midday Group 2: treatment as usual

Sponsors

Charité Universitätsmedizin BerlinKlinik für Radioonkologie und Strahlentherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Public ContactWiebke Stritter

Charité Universitätsmedizin

wiebke.stritter@charite.de030 450 566 077

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026