P&S Journal: Fall 1995, Vol.15, No.3
Clinical Trials: Recruitment, Sometimes Easy Sometimes a Thankless Task. The Adventures of Six Clinicians Recruiting Patients for Trials By Lynne Christensen;
Dr. Fredi Kronenberg, Hot Flashes at Menopause
Dr. Fredi Kronenberg attaches monitor leads to Gloria Jean-Jerome in preparation for her three-day stay at the Irving Center for Clinical Research, where the effects of ambient temperature on her hot flashes will be measured.
Dr. Fredi Kronenberg, associate professor of clinical physiology in rehabilitation medicine, director of the Richard and Hinda Rosenthal Center for Alternative/Complementary Medicine, and former Irving Clinical Research Scholar, has encountered notrouble recruiting subjects with hot flashes into her trial to study the effect of ambient temperature on sleep physiology and hot flashes in post-menopausal women.
The protocol of the study requires women with severe hot flashes to stay for 36 hours on three occasions, each at a different room temperature, at the CPMC Irving Center for Clinical Research. During the entire period, the subject's heart rate, skin resistance, and core and skin temperature are continuously recorded using an ambulatory monitor. At night, an EEG records the subject's sleep. One of the first participants in the study was more than willing to try something that might alleviate her troublesome hot flashes. The subject said of her time at the Irving Center: "It's better than being at a spa. The food is good, the atmosphere is relaxing, and I get to be away from the demands of my family."
Dr. Kronenberg is also about to begin an innovative clinical trial of Chinese herbal treatments for menopausal hot flashes, for which she has received
FDA approval. Even though she hasn't begun actively recruiting participants, word has spread and she has been deluged with requests from women who suffer various degrees of hot flashes and want to enter the trial. The only obstacle she foresees is getting patients to make a commitment to remain in the study for the entire year that the double- blind, placebo-controlled, crossover study will last.
Although attracting women with hot flashes to
her studies has been easy, she has not been as successful in attracting women to serve as controls. She runs advertisements in local newspapers and posts flyers around the medical center to attract postmenopausal women who do not experience hot flashes to serve as control subjects in her sleep study (on the effects of ambient temperature on sleep and hot flashes). So far, the response has been minimal.