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

Breast Cancer Clinical Trial

Official title:

Soy-rich Diet for Preventing Chronic Pain After Breast Cancer Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01047774
• Other study ID #: A02-M102-07A
• Secondary ID: 5R21CA125873-02
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2010
• Last updated: October 5, 2015
• Start date: March 2010
• Est. completion date: May 2013

Study information

• Verified date: October 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Disease
• Pain

Intervention

Dietary Supplement:
• Isolated soy protein
30-50g of protein powder daily for 2 weeks.
• Isolated milk protein
30-50g of protein powder daily for 2 weeks.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	St. Mary's Hospital Center	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Dr. Yoram Shir	Louise & Alan Edwards Foundation, McGill University, National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women in both arms with any pain of any type in operated breast or its vicinity		12 months post-surgery	No
Secondary	Pain intensity (acute)		Up to 7 days post-surgery	No
Secondary	Pain intensity (chronic)		Up to 12 months post-surgery	No
Secondary	Analgesic medication use		Up to 12 months post-surgery	No
Secondary	Pain quality		Up to 12 months post-surgery	No
Secondary	Anxiety and Depression		Up to 12 months post-surgery	No
Secondary	Disability		Up to 12 months post-surgery	No
Secondary	Adverse events		2 weeks during dietary supplementation	Yes
Secondary	Childhood and adolescence consumption of soy		Baseline	No
Secondary	Adverse events		Up to 12 months post-surgery	Yes