Whether cooling the scalp during chemotherapy can reduce hairfall in patients with cancer
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breast
- Registration Number
- CTRI/2023/05/053011
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hair preservation (HP) rateTimepoint: at the end of planned adjuvant/neoadjuvant chemotherapy
- Secondary Outcome Measures
Name Time Method adverse events due to coooling devceTimepoint: during the study after each cycle and at end of the study;change in quality of life using the Breast Cancer-Specific Quality of Life Questionnaire (EORTC BR 23)Timepoint: after 4 cycles of chemotherapy <br/ ><br>end of 4 months of chemotherapy;hair regrowthTimepoint: 3 months after completion of chemotherapy