Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 196
- Locations
- 4
- Primary Endpoint
- Compare the grade of the patient alopecia.
Study Overview
Brief Summary
The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France. Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust methodologies, remains a prerequisite for better integration of appropriate supportive care for patients receiving chemotherapy.
This research should provide new knowledge on the benefits of scalp refrigeration during anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2 refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life, self-image and satisfaction with care will be assessed by patients during and after chemotherapy. The medico-economic aspects will also be assessed for each of the two refrigeration modalities. The results of the various proposed assessments will be used to guide the choice between these two techniques for preventing ACI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Months to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically proven diagnosis of localised, non-metastatic breast cancer
- •Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3 or 4 EC100 followed by 3 Docetaxel or 3 or 4 EC100 plus 9 to 12 Paclitaxel); HER-positive status is not a non-inclusion criterion.
- •Patient willing to be photographed to assess IFA
- •Fluency in French
- •Patient affiliated to a social security scheme
- •Signature of informed consent
Exclusion Criteria
- •History of neck pain
- •Pre-existing alopecia
- •Participation in another trial
- •Dermatosis of the scalp
- •Contraindication to scalp cooling
- •History of migraines, stroke or hyperthyroidism
- •History of scalp metastases
- •Sensitivity to cold, cold agglutinin disease, cryoglobulinaemia, cryofibrinogenaemia or post-traumatic cold dystrophy.
- •Malignant haemopathies
- •History of chemotherapy treatment
- •Indication for cerebral irradiation
- •Pregnant or breast-feeding patient
- •Raynaud's syndrome
Arms & Interventions
standard cold-cap
Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.
This device will be supplemented by a compression bandage to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the effectiveness of the device.
Intervention: standard cold cap (Other)
scalp-cooling technique
Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.
Intervention: scalp-cooling technique (Other)
Outcomes
Primary Outcomes
Compare the grade of the patient alopecia.
Time Frame: At 6 months after treatment start
The grade of patient alopecia will be be evaluated by NCI-CTCAE
Secondary Outcomes
No secondary outcomes reported