The primary objective is to evaluate the effectivity of frozen gloves during chemotherapy in the prevention of neurotoxicity and thereby the influence on the quality of life in patients treated with oxaliplatin, paclitaxel or docetaxel.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
Quality of life and neuropathy symptoms are measured with the validated
European Organisation for the Research and Treatment of Cancer Quality of Life
Questionnaire (EORCT-QLQ) and with the validated CIPN20 self-report
questionnaire respectively at four time points (begin study, after three
cycles, end of chemotherapy and after 6 months).
Secondary outcome
Secundary objectives of the study are;
1) The degree of tolerance for the use of the frozen gloves measured with the
numering rating scale (NRS)
2) Dose reduction due to neurotoxicity.
3) Difference in neurotoxicity expressed in the common toxicity criteria (CTC).
4) Clustering of symptoms: do patients also have complaints in the feet and are
these similar to complaints of the hands?
Background summary
Rationale: Chemotherapy-induced peripheral neuropathy (CIPN) is a common major
dose-limiting side effect of many chemotherapeutic agents. CIPN leads to a
significant decrease in patient*s quality of life. Using frozen gloves during
chemotherapy could probably be used to prevent CIPN.
Study objective
The primary objective is to evaluate the effectivity of frozen gloves during
chemotherapy in the prevention of neurotoxicity and thereby the influence on
the quality of life in patients treated with oxaliplatin, paclitaxel or
docetaxel.
Study design
Study design: randomized controlled trial, open
Intervention (if applicable): Frozen gloves.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients will be asked to fill in a
questionnaire at different time points, that will take half an hour extra.
Frozen gloves will be used during chemotherapy, no extra visits are needed,
however an extra half an hour is required as the frozen gloves have to be worn
15 before initiation of the infusion until 15 minutes after the end of the
infusion. There are no studies carried out showing adverse effects of using
frozen gloves. A side-effect could be cold intolerance.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
• Written informed consent
• Patients aged > 18 years
• All cancer patients starting with paclitaxel, docetaxel or oxaliplatin
• Understand Dutch language
Exclusion criteria
• Patients with reported pre-existing neuropathy
• Patients with cold intolerance
• Patients with Raynaud*s syndrome
• Patients earlier treated with paclitaxel, docetaxel or oxaliplatin
• Patients using scalp cooling
• Short-term chemoradiation with paclitaxel, docetaxel or oxaliplatin
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39650.015.12 |