Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Scalp Cooling: During Each Cycle of Chemotherapy patients will undergo scalp cooling by a device called EVA scalp cooling device during the duration of the chemotherapy infusion.
Contro
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: Early and locally advanced breast cancer planned for adjuvant/ neoadjuvant chemotherapy involving anthracyclines and/ or taxanes. Patients receiving concurrent therapy with trastuzumab in Her2 positive breast cancers will be permitted to be enrolled. Plan to complete chemotherapy within 4-6 months. Both dose dense (every 2 weekly) and conventional (every 3 weeks) chemotherapy will be permitted ECOG PS 0-2 Able to give informed consent. Willing to participate in study and agree to have photographs of the head (no facial identification) taken from 5 directions at least 3 times. Patients who choose to wear a wig will be permitted
Exclusion criteria
Exclusion criteria: Patients with synchronous second cancers or any other malignancy. Patients who have already initiated chemotherapy or have already undergone chemotherapy. Patients who have received chemotherapy in the past for any cancer must have a minimum of 2 years gap from previous chemotherapy and must have fully regrown their hair. Preexisting hair fall, or other hair disorders like alopecia areata, skin conditions like lupus History of brain radiation Uncontrolled or poorly treated hypo or hyperthyroidism History of migraine headaches Patients with any other illness or health condition which in the opinion/medical judgment of the study investigator makes the patient ineligible to participate in the study. Patients who have shaved their heads before starting chemotherapy. No specific interventions for hair regrowth like serum injection etc. will be permitted, or agents like minoxidil will not be permitted. If the head size is not properly fitting the device cap size Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hair preservation (HP) rateTimepoint: at the end of planned adjuvant/neoadjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| change in quality of life using the Breast Cancer-Specific Quality of Life Questionnaire (EORTC BR 23)Timepoint: after 4 cycles of chemotherapy end of 4 months of chemotherapy;adverse events due to coooling devceTimepoint: during the study after each cycle and at end of the study;hair regrowthTimepoint: 3 months after completion of chemotherapy | — |
Countries
India
Contacts
Public ContactRebekah C
JIPMER
Outcome results
None listed