Red Clover and Lifestyle Changes to Contrast Menopausal Symptoms in Premenopausal Breast Cancer Patients Given Tamoxifen

• Status: Completed
• Trial end date: 2016-02-23
• Target enrollment: 0
• Participant gender: Female

Summary

A prospective double-blind randomized trial of red clover extract (Promensil) vs placebo in surgically-treated premenopausal women with estrogen receptor-positive breast cancer taking tamoxifen

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Criteria

Inclusion Criteria:

• Histologically confirmed operable ER-positive breast cancer

• Can be ductal carcinoma in situ (DCIS)

• Absence of locoregional relapse or distant metastasis

• Normal ovarian function

• Menopause Rating Score > or equal to 8

• Signed informed consent to participate

Exclusion Criteria:

• Menopause Rating Score <8

• Menopausal at diagnosis or at surgery

• Previous malignancies other than in situ cervical carcinoma or non-melanoma skin cancer

• Breast cancer recurrence

• Metastatic breast cancer

• Non-epithelial breast cancer at histological examination

• In situ lobular breast cancer

• Participation in other randomized clinical trials that could interfere with current study

• Living distant from center and unable to attend for check-ups and meetings.