Spots Global Cancer Trial Database for Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)
Official Title: Amma™ Portable Scalp Cooling System (PSCS) Study: A Post-market Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Early-stage Breast Cancer
Study ID: NCT06215469
Study Description
Brief Summary: The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.
Detailed Description: PRIMARY OBJECTIVE: I. To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last chemotherapy (CT) treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE) by comparing post-treatment photographs to pre-treatment photographs. SECONDARY OBJECTIVES: I. To assess safety of the Amma PSCS based on the occurrence of device-related adverse events, occurrence of scalp changes determined by physical examination, and patient symptoms with use of the PSCS. II. To evaluate hair loss as measured by the patient at 3 weeks (±1 week) after the completion of the last treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE v5.0 or above) by comparing post-treatment photographs to baseline photographs. III. To assess tolerability/compliance with use of the PSCS. IV. To assess patient quality of life and satisfaction with hair preservation after Amma PSCS usage using the Body Image Scale (BIS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) for Breast Cancer (EORTC-QLQ-BR23) questionnaire. OUTLINE: Participants will use the AMMA PSCS while receiving non-investigational, chemotherapy treatments. Participants may continue device usage through their last cycle of chemotherapy (approximately 6 months) and will be followed for 30 days after the last device usage date, until removal from study, or until death, whichever occurs first.
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, San Francisco, San Francisco, California, United States
Contact Details
Name: Hope Rugo, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
