Study on how cancer treatment affects women's sexual and reproductive health
Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
This study looks at how cancer treatments affect the sexual and reproductive health of premenopausal women with early-stage breast cancer or aggressive lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 475 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT01788839 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the impact of cancer treatments on the sexual and reproductive health of women diagnosed with breast cancer and lymphoma. Participants will complete surveys and may opt for blood draws to assess ovarian function and fertility. The study focuses on premenopausal women who are either newly diagnosed or undergoing treatment for early-stage breast cancer or aggressive lymphoma. The research will help understand the long-term effects of cancer therapies on women's reproductive health.
Who should consider this trial
Good fit: Ideal candidates include premenopausal women aged 18 and older with early-stage breast cancer or aggressive lymphoma who are starting systemic treatment.
Not a fit: Patients who are postmenopausal or those who do not meet the specific inclusion criteria for the study may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into preserving fertility and sexual health in women undergoing cancer treatment.
How similar studies have performed: Other studies have explored similar themes regarding cancer treatment and reproductive health, indicating a growing interest in this area, though specific outcomes vary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subject Inclusion Criteria for Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma * Women, 18 years of age and older * Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months * Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months. * Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent. * Breast cancer patients with any receptor type * English speaking * Able to participate in the informed consent process Subject Inclusion Criteria for Tamoxifen Only Subset of Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma * Women, 18 years of age and older. * Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months * Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months. * Women with newly diagnosed breast cancer (stage 0-III) who have not yet started treatment and are planning to start Tamoxifen as their only form of systemic treatment within one month * Breast cancer patients with any receptor type * English speaking * Able to participate in the informed consent process Subject Inclusion Criteria for Cohort of Postmenopausal Women with Early Stage Breast Cancer and Lymphoma * Women, 18 years of age and older. * Postmenopausal women at time of diagnosis who have been without period for ≥ 2 years. * Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent. * Breast cancer patients with any receptor type * English speaking * Able to participate in the informed consent process Exclusion Criteria: Subject Exclusion Criteria for both Pre and Postmenopausal Women with Early Stage Breast Cancer and Lymphoma * Active secondary cancer requiring cytotoxic chemotherapy * Prior systemic treatment for a malignancy
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Shari Goldfarb, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Shari Goldfarb, MD
- Phone: 646-888-5080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.