- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01047774
The Effect of Soy Protein on Post- Breast Cancer Surgery Pain
Soy-rich Diet for Preventing Chronic Pain After Breast Cancer Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3G 1A4
- McGill University Health Centre
-
Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
-
Montreal, Quebec, Canada, H3A 1A1
- Royal Victoria Hospital
-
Montreal, Quebec, Canada, H3T 1M5
- St. Mary's Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Soy protein
|
30-50g of protein powder daily for 2 weeks.
Other Names:
|
Placebo Comparator: Milk protein
|
30-50g of protein powder daily for 2 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of women in both arms with any pain of any type in operated breast or its vicinity
Time Frame: 12 months post-surgery
|
12 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain intensity (acute)
Time Frame: Up to 7 days post-surgery
|
Up to 7 days post-surgery
|
Pain intensity (chronic)
Time Frame: Up to 12 months post-surgery
|
Up to 12 months post-surgery
|
Analgesic medication use
Time Frame: Up to 12 months post-surgery
|
Up to 12 months post-surgery
|
Pain quality
Time Frame: Up to 12 months post-surgery
|
Up to 12 months post-surgery
|
Anxiety and Depression
Time Frame: Up to 12 months post-surgery
|
Up to 12 months post-surgery
|
Disability
Time Frame: Up to 12 months post-surgery
|
Up to 12 months post-surgery
|
Adverse events
Time Frame: 2 weeks during dietary supplementation
|
2 weeks during dietary supplementation
|
Childhood and adolescence consumption of soy
Time Frame: Baseline
|
Baseline
|
Adverse events
Time Frame: Up to 12 months post-surgery
|
Up to 12 months post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yoram Shir, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A02-M102-07A
- 5R21CA125873-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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