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Prospective Non-interventional Study of Tumor-associated Fatigue Syndrom under Taxane Therapy - FaTa-P(aclitaxel)

Prospective Non-interventional Study of Tumor-associated Fatigue Syndrom under Taxane Therapy - FaTa-P(aclitaxel) - FaTa - P(aclitacel)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00006016
Enrollment
500
Registered
2014-03-24
Start date
2014-04-25
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

Fatigue, cancer related

Interventions

Group 1: Patients with histologically or cytologically diagnosed various tumor entities for which a therapy with Paclitaxel LIV Pharma is indicated according to the SPC.

Sponsors

LIV Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Minimum Age 18 years - Informed Consent - Underlying Tumor disease of breast, lung or ovarian - No pregnancy - Therapy with Paclitaxel LIV Pharma - The current therapy was started no more than 12 weeks ago - No simultaneous, further study participation

Exclusion criteria

Exclusion criteria: - Contraindications to the use of oxaliplatin LIV Pharma according to the SmPC. - The current therapy was started more than 12 weeks ago. - The patient is participating in a study at the same time. - Pregnancy is present or the patient is breastfeeding.

Design outcomes

Primary

MeasureTime frame
Course of Fatiguesyndroms, assessed by MFI questionnaire (mulitdimensional fatigue inventory) at baseline, cycles 2, 4, 6, 8, 10, 12, end of treatment and follow-up visits 1-3 as well as BSA-Questionnaire on physical activity and sports activity assessed at cycles 1, 5 , 9, end of treatment and follow-up examinations 1-3

Secondary

MeasureTime frame
Course the Quality of Life collected by questionnaire EORTC C30-v 3.0 at baseline, cycles 4, 8, 12, end of treatment and follow-up visits 1 -3

Countries

Germany

Contacts

Public ContactBurkard Heckelbacher

Datafaber GbR

heckelbacher@datafaber.de+49 8161 885 107

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026