A multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26657

Enrollment

260

Registered

2005-07-12

Start date

2005-08-03

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Hair loss

Interventions

Scalp cooling with various cooling times or cooling temperatures.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Intravenous administered docetaxel regimes; 2. Age 18 years or more; 3. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Boldness before the start of the study; 2. Heamatological malignancies with generalized haematogenic metastases (e.g. lymphoma, leukemia and multiple myeloma) and if in those conditions chemotherapy is given with a curative intent; 3. Clinical signs of scalp metastases; 4. Cold sensitivity; 5. Cold agglutinin disease; 6. Cryoglobulinemia; 7. Cryofibrinogenemia.

Design outcomes

Primary

Measure	Time frame
Efficacy and patient acceptability of scalp cooling.	—

Secondary

Measure	Time frame
Relation of the efficacy of scalp cooling and: 1. prior treatment with cytostatic agents; 2. prior or parallel hormonal treatment; 3. prior radiotherapy of the scalp; 4. liver metastases and/ or liver or kidney function disorder; 4. type of hair (determined by race).	—

Contacts

Public ContactCorina Hurk, van den

Integraal Kankercentrum Zuid, sector onderzoek, Zernikestraat 29

c.vd.hurk@ikz.nl+31 (0)40 2971616

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)