Scalp Cooling for Breast Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Dana-Farber Cancer Institute
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing if the Paxman Scalp Cooling System can prevent hair loss in people with advanced breast cancer who are receiving specific treatments. The cooling system works by lowering the scalp temperature to protect hair from the effects of these treatments. The Paxman Scalp Cooling System has been studied in multiple trials and shown to be effective in reducing treatment-induced hair loss in breast cancer patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving any additional anti-cancer agents.
How does scalp cooling differ from other treatments for breast cancer?
Scalp cooling is a unique treatment for breast cancer patients that helps prevent hair loss during chemotherapy by reducing the temperature of the scalp, which decreases blood flow to hair follicles and minimizes the impact of chemotherapy drugs on them. This approach is different from other treatments that focus on directly targeting cancer cells or managing surgical outcomes.
12345Eligibility Criteria
This trial is for adults with metastatic breast cancer who have hair and are starting one of three specific chemotherapy treatments. They must be in good enough health to participate, not have other cancers or scalp metastases, no baseline alopecia, and can't have certain conditions like cold agglutinin disease.Inclusion Criteria
I am planned to receive one of the specified chemotherapy treatments for at least 4 cycles.
I have metastatic breast cancer and can care for myself.
I am 18 years old or older.
Exclusion Criteria
I am experiencing some level of hair loss.
My cancer has spread to my scalp.
I am scheduled for chemotherapy to destroy my bone marrow.
I am currently taking medication to treat my cancer.
I have a blood cancer, such as leukemia or lymphoma.
I have lichen planus or lupus.
Participant Groups
The study tests the Paxman Scalp Cooling System's effectiveness at preventing hair loss during chemotherapy (sacituzumab govitecan, trastuzumab deruxtecan, or eribulin) in metastatic breast cancer patients. Participants will either use the cooling system or not as a comparison.
6Treatment groups
Experimental Treatment
Active Control
Group I: TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)Experimental Treatment2 Interventions
Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with TRASTUZUMAB DERUXTECAN.
Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Group II: SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)Experimental Treatment2 Interventions
Participants will use Paxman Scalp Cooling System (PSCS) on days 1 and 21 of each of their standard of care (SOC) treatment cycles with SACITUZUMAB GOVITECAN.
Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Group III: ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)Experimental Treatment2 Interventions
Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with Eribulin.
Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Group IV: ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)Active Control1 Intervention
Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with Eribulin.
Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Group V: SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)Active Control1 Intervention
Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with SACITUZUMAB GOVITECAN.
Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Group VI: TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEMActive Control1 Intervention
Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with TRASTUZUMAB DERUXTECAN.
Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Dana Farber Cancer InstituteBoston, MA
Brigham and Women's HospitalBoston, MA
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
Daiichi SankyoIndustry Sponsor
Gilead SciencesIndustry Sponsor
Eisai Inc.Industry Sponsor
Daiichi Sankyo, Inc.Industry Sponsor
Paxman Coolers LimitedCollaborator
AstraZenecaIndustry Sponsor
References
The effect of plasmakinetic cautery on wound healing and complications in mastectomy. [2022]Surgical equipment used in breast cancer surgery that affects wound healing and minimizes complications seems to be a popular investigation topic. The aim of this study is to evaluate the effect of plasmakinetic cautery on wound healing in patients receiving mastectomy.
A comparison between electrocautery and scalpel plus scissor in breast conserving surgery. [2006]Breast conserving therapy (BCT) was originally developed to achieve the same survival outcome as mastectomy while improving the quality of life. In fact, this approach resulted in high local control rates, but 30% of patients treated with BCT using electrocautery had a fair or poor cosmetic result at the 3-year follow-up. In 106 patients with stage I and II breast cancer treated by wide excision and axillary dissection using scalpel plus scissor or electrocautery followed by radiation therapy, the histological damage and cosmetic results were analyzed. The duration of operation in the scalpel plus scissor group was shorter than that in the electrocautery group, although blood loss was greater. The electrocautery caused extensive histological tissue damage to the stump compared with the scalpel plus scissor group. The cell death by TUNEL method was significantly increased on electrocautery groups. In addition, although the global cosmetic result of the electrocautery group was similar to that of the scalpel plus scissor group after surgery, the scalpel plus scissor group had a much better cosmetic outcome after surgery and radiation therapy at the 3-year follow-up. Clinical tumor size T1 and pathological tumor size over 2 cm were factors that negatively affected the cosmetic score after surgery in each group. Scalpel plus scissor in breast conserving surgery has less tissue damage and better cosmetic results at the 3-year follow-up.
Thermal evaluation of breast disease using local cooling. [2015]A simple, inexpensive local cooling system for thermal evaluation of breast disease is described. Skin temperature measured during a 10-minute cooling process averaged 1.2degrees C higher over 31 proved cancers and 0.6degrees C lower over 18 benign masses. Forty-nine masses averaged 1.7 cm in diameter and were 1.5 cm deep; 23 of 31 malignancies (74%), 16 of 18 benign growths (88%), and 46 of 52 "normals" (88%) would have been correctly diagnosed, while results for 10 of 22 women (45%) with asymmetrical diffuse non-malignant disease would have been falsely classified positive.
Scalpel versus electrocautery in modified radical mastectomy. [2022]Forty nine consecutive mastectomy patients were randomized to one of two groups. Twenty four patients had skin flaps created with the cold scalpel and twenty five with the electrocautery. The two groups were similar with respect to age, stage of disease, size of tumor, and weight. Cautery patients had significantly less operative blood loss when compared with scalpel patients, 352 versus 507 milliliters, respectively, P less than 0.05. No cautery patient required transfusion compared with three transfused scalpel patients, P less than .005. Total postoperative hemovac drainage and hospital stay were not significantly different between the two groups. Although the number of fever days and wound complications were slightly higher in the cautery group, the difference was not statistically significant. The electrocautery may be superior to the scalpel for mastectomy.
Radical breast surgery with a contact Nd:YAG laser scalpel. [2007]The use of a contact Nd:YAG laser scalpel during radical and modified radical mastectomy was evaluated in 18 patients with carcinoma of the breast. The laser scalpel performed well as a haemostatic tool, the associated mean blood loss for modified radical mastectomy being 132 ml. Operating time, operative blood loss, laser energy required and postoperative wound drainage were all related to patient obesity, correlating significantly with body weight and/or breast weight. The incidence of axillary seroma was not reduced by laser surgery and occurred in 53% of patients undergoing modified radical mastectomy. The Nd:YAG laser scalpel is an excellent haemostatic tool but it does not appear to have any other advantages over conventional surgery for mastectomy.