|- candidate number||5924|
|- NTR Number||NTR1856|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jun-2009|
|- Secondary IDs||M09-1930 Catharina Ziekenhuis Eindhoven|
|- Public Title||Multicentric trial on the effectiveness of shortened post-infusion scalp cooling times in the prevention of docetaxel-induced hair loss.|
|- Scientific Title||Multicentric trial on the effectiveness of shortened post-infusion scalp cooling times in the prevention of docetaxel-induced hair loss.|
|- hypothesis||Comparable results of scalp cooling in post-infusion cooling times of 20 and 45 minutes.|
|- Healt Condition(s) or Problem(s) studied||Hair loss, Chemotherapy|
|- Inclusion criteria||1. Intravenous administered docetaxel-regimens at 3-weekly intervals;|
2. Age 18 years or more;
3. Written informed consent.
|- Exclusion criteria||1. TAC chemotherapy;|
2. Sequential docetaxel following FEC or AC chemotherapy;
3. Baldness before the start of the study;
4. Heamatological malignancies;
5. Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold post-traumatic dystrophy.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-jun-2009|
|- planned closingdate||31-dec-2010|
|- Target number of participants||100|
|- Interventions||Randomly assigned post-infusion scalp cooling time of 20 or 45 minutes.|
|- Primary outcome||Proportion of patients not in need of wig or head cover.|
|- Secondary outcome||1. Impact of prior chemotherapy or hormonal therapy and liver or kidney function disorders on the result of scalp cooling;|
2. The amount and pattern of hair loss;
3. Quality of hair during scalp cooling;
4. Reasons to stop scalp cooling.
|- Timepoints||Stop patient inclusion dd 31-12-2010.|
|- Trial web site||www.geefhaareenkans.info|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. Corina Hurk, van den|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Corina Hurk, van den|
|- Sponsor/Initiator ||Comprehensive Cancer Center South (IKZ)|
(Source(s) of Monetary or Material Support)
|Sanofi-Aventis, Private gifts, Comprehensive Cancer Center South (IKZ)|
|- Brief summary||Background of the study:|
Alopecia, hair loss, is a common and distressing side effect of chemotherapy. Scalp cooling is practiced in order to reduce hair loss in patients receiving chemotherapy. In the literature methods and results of scalp cooling vary remarkably. However, in general, positive outcomes are reported and scalp cooling is well tolerated by most patients.
Although scalp cooling has been practiced for many years, several essential questions still have to be answered. One remaining question is the optimal post-infusion cooling time.
Previous research showed comparable results of scalp cooling with post-infusion cooling times of 90 and 45 minutes in patients treated with docetaxel in a 3-weekly schedule. Maybe an even shorter post-infusion cooling time is sufficient to keep the good results, which would be an advantage in time investment for the patient, but also for the day care unit.
Objective of the study:
Determination of differences in results of scalp cooling with post-infusion cooling times of 45 versus 20 minutes in 3-weekly docetaxel schedules.
This is a prospective multicentric trial. Patients will be randomly assigned to a post-infusion cooling time of 45 versus 20 minutes.
Patients treated with 3-weekly docetaxel chemotherapy and who choose for scalp cooling. Both randomisation arms will include 50 patients.
Randomisation between 45 and 20 minutes post-infusion cooling times. Patients will complete a questionnaire during each scalp cooling session.
Primary study parameters/outcome of the study:
The primary study parameter is the proportion of patients that needs a wig or head cover after termination of scalp cooling.
Secundary study parameters/outcome of the study:
Secundary parameters are related to liver and kidney disorders, impact of other chemotherapies or hormonal therapy, the amount and pattern of hair loss, quality of the hair during scalp cooling and reasons to stop scalp cooling.
|- Main changes (audit trail)|
|- RECORD||11-jun-2009 - 19-feb-2017|