Effects of Chemotherapy, Premature Ovarian Failure
Conditions
Keywords
new diagnosis of cancer, chemotherapy, oncofertility, alkylating agent, fertility preservation, fertility after cancer, late effects
Brief summary
Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.
Detailed description
A total of 7 study visits will be completed at 3 month intervals including 1 visit prior to treatment, and at least 2 visits after completion of treatment. Duration of study participation is 18-30 months, depending on length of treatment. Review and Documentation of Cancer Therapy will be abstracted from the clinical oncology chart by the oncology offices caring for the patient. Treatment will be summarized in terms of chemotherapeutic type, duration and cumulative dose; total radiation dose and location; history and type of bone marrow transplantation; and any surgery. Any attempts at fertility preservation or use of gonadotropin releasing hormone agonist treatment during cancer therapy will be captured as well.
Interventions
None listed
Sponsors
Children's Hospital of Philadelphia
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
for exposed population: * Postmenarchal females to be treated with chemotherapy * between the ages of 11-35 years, * with a uterus and at least one ovary Inclusion Criteria for unexposed population: * healthy postmenarchal females * no prior or planned exposure to chemotherapy * between the ages of 11-35, * with a uterus and at least one ovary * regular menstrual cycles (21-35 days)
Exclusion criteria
for all subjects: * positive pregnancy test at enrollment * lactation within the previous 1 month, * previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer. * previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier) * endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia). Additional exclusions for the unexposed population: * a history of infertility, defined as at least 12 months of unprotected intercourse without conception * polycystic ovary syndrome (PCOS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in reproductive hormone measures, during and after chemotherapy. | 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. | 20 mls blood will be obtained at stated timepoints for determining levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Inhibin B, and Anti-mullerian Hormone (AMH). In menstruating girls and young women hormone measures will be obtained during the early follicular phase of the menstrual cycle (days 1-4). In women with irregular cycles the testing will be done spontaneously without regard for the bleeding pattern. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in antral follicle counts, during and after chemotherapy. | 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in menstrual function, during and after chemotherapy | 18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. | Subjects are asked to document menstrual bleeding in a diary, noting duration of each menstrual period in days, bleeding intensity (spotting, light, moderate, heavy, flooding, none), and intervals between periods. |
| Change from baseline in menopausal symptoms during and after chemotherapy. | 18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. | The validated Menopausal Symptom List (MSL) will be used at each study visit to assess the presence or absence of menopausal symptoms during the past month, the frequency and severity of each symptom. Symptoms captured include: hot flashes, vaginal dryness, concentration/memory problems, irritability, mood swings, feeling sad, feeling anxious, trouble sleeping, aches, joint pain, headaches. |
| Change from baseline in ovarian volume during and after chemotherapy. | 18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. | Ovaries will be measured in three dimensions. Uterine size and endometrial thickness will also be performed. The transvaginal approach is preferred, but transabdominal ultrasound will be performed in girls who do not feel comfortable with the transvaginal procedure. |
Countries
United States
Outcome results
None listed