Effects of Chemotherapy
Conditions
Keywords
Oncofertility, Fertility, Late effects, cancer, chemotherapy, radiation therapy, survivor, ovarian reserve, premature ovarian failure, early menopause, healthy volunteers, perimenopause, middle age, pediatric survivors, healthy women
Brief summary
Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose therapy. At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood hormones tests will be used to measure ovarian reserve , that is the number and quality of the eggs that remain in the ovaries. The study will also try to learn if those who received higher doses of certain chemotherapies are more likely to have changes in these tests sooner than those women who received smaller doses of these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look for gene variations that may predict susceptibility to ovarian damage from cancer treatments. Information learned from this study may help researchers to develop guidelines to identify problems with a female cancer survivor's ovaries before irregular menses or other symptoms of ovarian failure occur.
Detailed description
Up to 400 females will participate in this study in one of three cohorts: * 150 females ages 11-35, with history of exposure to alkylating agent chemotherapy and/or radiation therapy * 150 Unexposed peers, ages 11-35, never exposed to chemotherapy or radiation therapy * 100 Unexposed females, ages 40-50 never exposed to chemotherapy or radiation therapy
Interventions
None listed
Sponsors
Children's Hospital of Philadelphia
University of Pennsylvania
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
for cancer survivors: * Previous treatment with chemotherapy and/or radiation therapy for either cancer or another illness. * Age between 11-35 years. * Post-menarchal. * Presence of a uterus and at least one ovary. * Ability and willingness to comply with study protocol. * Have given written informed consent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. Inclusion Criteria for controls: * Healthy females who have never been treated for cancer. * Age between 11-35 and 40-50 years. * Post-menarchal with regular cyclic menses (every 21-35 days) * Presence of a uterus and at least 1 ovary. * Ability and willingness to comply with study protocol. * Have given written informed concent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Exclusion criteria
* Current pregnancy. * Use of hormonal contraception or use of hormone replacement therapy within the previous 4 weeks. * Lactation within the previous 3 months. * Chronic illness that would limit ability of participant to comply with study protocol. * Any known medical condition, other than cancer, which in the judgement of the investigator is known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, adrenal dysfunction, Cushing's syndrome, hyperprolactinemia, and polycystic ovarian syndrome). * For controls, a history of infertility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reproductive hormones | Annually for 3-5 years | Primary Outcomes for this study will include mean and changes in reproductive hormone measures obtained during the early follicular phase of the menstrual cycle (days 1-4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antral Follicle Counts | Annually for 3-5 years | All ovarian follicles and cysts will be measured by transvaginal or transabdominal ultrasound. Follicles will be measured in millimeters and grouped according to size: 2-5 mm, 6-9 mm, and \>10 mm in diameter. |
Countries
United States
Outcome results
None listed