Multicentric trial on the effectiveness of shortened post-infusion scalp cooling times in the prevention of docetaxel-induced hair loss.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27012

Enrollment

100

Registered

2009-06-11

Start date

2009-06-15

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

chemotherapy-induced hair loss (Dutch: haarverlies door chemotherapie)

Interventions

Randomly assigned post-infusion scalp cooling time of 20 or 45 minutes.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Intravenous administered docetaxel-regimens at 3-weekly intervals; 2. Age 18 years or more; 3. Written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients not in need of wig or head cover.	—

Secondary

Measure	Time frame
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.	—

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)