Soy-rich Diet for Preventing Chronic Pain After Breast Cancer Surgery
21 Years
N/A
Female
Pain, Chronic Disease, Breast Cancer
Trial Information
Soy-rich Diet for Preventing Chronic Pain After Breast Cancer Surgery
Preclinical studies indicate that soy consumption suppresses the development of pain
behavior and hyperalgesia following nerve injury. The pain-suppressing properties of soy
protein have been shown to be predominately the result of soy pre-operative consumption.
This is a randomized, double blind, placebo-controlled clinical trial for women diagnosed
with breast cancer and scheduled to undergo breast cancer surgery. The trial will comprise
two phases: 1. A 2-week preoperative dietary manipulation phase, and 2. A one-year
postoperative follow up period. In the first phase eligible candidates will undergo a basic
dietary evaluation followed by stratification into 4 study groups, based on their pre-vs.
postmenopausal status and the planned type of surgery, i.e., formal mastectomy vs.
breast-conserving surgery. Women in each group will be randomized to receive either powdered
soy protein in the experimental group or milk protein in the control group. During the
second, post-surgical phase women will resume their normal diet. If shown to be beneficial,
this simple dietary manipulation may prevent one of the most severe sequelae of breast
cancer.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Number of women in both arms with any pain of any type in operated breast or its vicinity
Outcome Time Frame:
12 months post-surgery
Safety Issue:
No
Principal Investigator
Yoram Shir, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
McGill University Health Center
Authority:
Canada: Health Canada
Study ID:
A02-M102-07A
NCT ID:
NCT01047774
Start Date:
March 2010
Completion Date:
March 2013
Related Keywords:
- Pain
- Chronic Disease
- Breast Cancer
- soy protein
- diet
- Breast Neoplasms
- Chronic Disease
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