ClinicalTrials.gov reports that researchers are conducting a large clinical trial designed to learn more about how chemotherapy affects the ability to think. Specifically, doctors at Memorial Sloan-Kettering Cancer Center in New York City want to know whether chemotherapy agents damage the DNA of women treated for breast cancer, and whether DNA damage is related to problems thinking.
This kind of research, with a large enough group to be statistically significant and a group of healthy “control” subjects, is ultimately going to drive the science of chemotherapy and cognition to a new level. In other words, trials like this may give doctors new insights into cancer treatment and brain function that could help the millions of breast cancer survivors in the United States. It might also translate to other cancers, too.
“Some research has shown that chemotherapy can cause changes in cognition [thinking] in breast cancer survivors,” the doctors write. “However, it is not clear why this change occurs. In this study, the investigators will look to see if damage to DNA is related to these changes in cognition.”
Doctors hope to enroll 150 women, all between 50 and 70 years old, at three different MSKCC sites: in New York City, in Commack, New York, and in Rockville Centre, New York.
The study, which began in June 2007, will be completed by June 2010. Women participating in the trial will be divided into three different groups, according to the information posted on ClinicalTrials.gov:
- Breast cancer survivors 2-6 years post-treatment who were post-menopausal at the time of diagnosis and treated with a combination of chemotherapy and hormonal therapy.
- Breast cancer survivors 2-6 years post-treatment who were post-menopausal at the time of diagnosis and treated only with hormonal therapy.
- Healthy women.
All participants will be given a mini “mental state exam” — a neuropsychological test that takes abou 2 hours to finish. Blood samples will also be drawn. Participants will be matched by age and education, as well — allowing researchers to draw valid, apples-to-apples comparisons.
The researchers conducting the trial, Dr. Tim Ahles and Dr. Denise Correa, write that “the primary objective of this proposal is to obtain preliminary data regarding the association between DNA damage and cognitive functioning in breast cancer survivors.”
They predict that breast cancer survivors treated with chemotherapy and hormonal therapy will have higher levels of DNA damage, compared with those treated only with hormonal therapy, and compared with the healthy women.
They also expect to find that those who show signs of cognitive impairment on tests will have higher levels of DNA damage.