Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma

Breast Cancer Clinical Trial

Official title:

Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01788839
• Other study ID #: 12-249
• Status: Recruiting
• Start date: February 2013
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Shari Goldfarb, MD
• Phone: 646-888-5080
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to see how cancer treatment affects sexual and reproductive function. The patient will also be asked to participate in blood draws to see if and how cancer treatment affects the ovaries and the ability to have children (fertility). These blood draws are optional and the patient can still participate in the questionnaire portion of the study even if they choose not to have their blood drawn.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Behavioral:
• surveys
A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Modified Female Sexual Function Index Follow-Up (FSFI-M Follow-Up) the Sexual Activity Questionnaire (SAQ), the Female Sexual Distress Scale (FSDS-R), the Menopausal Symptom Check List (MSCL), Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF), Abbreviated Dyadic Adjustment Scale for Relationships (ADAS), Reproductive Health Survey-baseline (RHS-B). Reproductive Health Survey-followup and (RHS-F1)Reproductive Health Survey-followup (RHS-F2) will be conducted at the following intervals: baseline/before chemotherapy +/- 1 month, 3 months after baseline +/- 1 month, 6 months after baseline +/- 1 month, 1 year after baseline +/- 1 month, and at intervals during survivorship that include yearly for 5 years +/- 2 months.

Other:
• Blood draw
Those patients receiving chemotherapy who consent to the optional blood draw will provide blood at baseline (before start of chemotherapy), 12 months after baseline (+/-1 month) and 24 months after baseline (+/-2 months). All patients in the subset of the premenopausal cohort receiving tamoxifen only will have required blood draws at baseline (before they begin taking tamoxifen), at 6 months post-baseline/start of tamoxifen (+/- 2 weeks), 12 months post-start of tamoxifen (+/-1 month) and 24 months post-start of tamoxifen (+/-2 months). We will ask these participants for blood draws on day 1, 2, 3 or 4 of their menses at baseline and 6 months post-baseline/start of tamoxifen and during months 1 through 5 post-baseline/start of tamoxifen.

Device:
• Transvaginal ultrasounds
Transvaginal ultrasounds are used to determine the number of antral follicles in each ovary. They will be performed to evaluate both the number and size of antral follicles of premenopausal women on Tamoxifen as antral follicle count is a good predictor of ovarian reserve and response. All patients in the subset of the premenopausal cohort receiving tamoxifen only will also have required transvaginal ultrasounds at baseline (before they begin taking tamoxifen) and at 6 months post-start of tamoxifen (+/- 2 weeks).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine the natural history of sexual and reproductive health		5 years
Secondary	predictors of sexual dysfunction during and after treatment		5 years
Secondary	impact of treatment on self-reported future pregnancy/reproductive health		5 years
Secondary	factors that influence decisions regarding fertility preservation	Before treatment and family building after treatment	5 years
Secondary	comparison of sexual function between breast cancer and lymphoma patients		5 years

External Links

•   Memorial Sloan-Kettering Cancer Center