Skip to content

The Effect of Soy Protein on Post- Breast Cancer Surgery Pain

TerminatedPhase 2NCT01047774
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

The incidence of chronic pain after breast cancer surgery (CPBCS) is high in women diagnosed with breast cancer. Similar to other chronic postoperative pain conditions, existing treatments for CPBCS do not always work. Adopting the concept of using pain relieving measures prior to surgery rather than after it, may lead to decreased postoperative pain levels. Soy has been shown to have pain-relieving properties and may reduce the risk for developing chronic post-surgical pain. The purpose of this study is to determine the effects of adding soy protein to the diet before surgery on the development of chronic pain.

Study details

Official title
Soy-rich Diet for Preventing Chronic Pain After Breast Cancer Surgery
Interventions
  • Dietary supplement: Isolated soy protein
  • Dietary supplement: Isolated milk protein
Sponsor
Dr. Yoram Shir
Collaborators
National Cancer Institute (NCI); Louise & Alan Edwards Foundation; McGill University
Organization
McGill University Health Centre/Research Institute of the McGill University Health Centre
Start date
2010-03
Primary completion
2013-05
Sex
Female
Age range
from 21 Years to 99 Years
Results posted
No results posted in this snapshot
Countries
Canada
Total sites listed
4

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Women diagnosed with breast cancer and scheduled for elective breast cancer surgery (excluding breast biopsy) with axillary lymph node dissection (total and/or sentinel node excision). * Women who are 21 years or older. Exclusion Criteria: * History of significant heart, gastro-intestinal, liver or kidney disease. * Use of the anticoagulant, warfarin or Coumadin. * Malabsorption of any kind. * Diagnosed lactase deficiency. * Known allergy to any of the tested dietary products. * Basic daily consumption of soy protein in quantities exceeding 10 g/day. * Women who are strict vegetarians (i.e. no animal derived dietary sources). * The use of the following narcotics or adjuvant pharmacotherapy: opioids, anticonvulsants, antidepressants and steroids (except antidepressant use specifically for depression). * Tumour size (if known) \> 3cm(i.e. size before pre-operative chemotherapy, if administered). * Locally advanced breast cancer. * Inflammatory breast cancer. * Paget's disease of the breast with palpable mass. * Suspected metastasis. * Suspected micrometastasis. * Previous breast surgery of any kind (except needle biopsy). * The need for bilateral breast surgery. * The existence of other known cancer, including metastasis, either in the other breast or elsewhere. * Previous or current endocrine cancer therapy (e.g. selective estrogen receptor modulators, aromatase inhibitor). * Body mass index (BMI) \> 35.

Canadian sites (4)

FacilityCityProvince
Jewish General HospitalMontrealQuebec
McGill University Health CentreMontrealQuebec
Royal Victoria HospitalMontrealQuebec
St. Mary's Hospital CenterMontrealQuebec

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01047774