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

Primary Purpose

Pain, Chronic Disease, Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Isolated soy protein

Isolated milk protein

About this trial

This is an interventional prevention trial for Pain focused on measuring soy protein, diet

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Royal Victoria Hospital
McGill University Health Centre
Jewish General Hospital
St. Mary's Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Soy protein

Milk protein

Arm Description

Outcomes

Primary Outcome Measures

Number of women in both arms with any pain of any type in operated breast or its vicinity

Secondary Outcome Measures

Pain intensity (acute)

Pain intensity (chronic)

Analgesic medication use

Pain quality

Anxiety and Depression

Disability

Adverse events

Childhood and adolescence consumption of soy

Adverse events

Full Information

NCT ID

NCT01047774

First Posted

January 12, 2010

Last Updated

October 5, 2015

Sponsor

Dr. Yoram Shir

Collaborators

National Cancer Institute (NCI), Louise & Alan Edwards Foundation, McGill University

1. Study Identification

Unique Protocol Identification Number

NCT01047774

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

Difficulty with recruitment - few eligible for enrolment.

Study Start Date

March 2010 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Yoram Shir

Collaborators

National Cancer Institute (NCI), Louise & Alan Edwards Foundation, McGill University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Chronic Disease, Breast Cancer

Keywords

soy protein, diet

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Soy protein

Arm Type

Experimental

Arm Title

Milk protein

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Isolated soy protein

Other Intervention Name(s)

PRO-FAM 873, Code #066873

Intervention Description

30-50g of protein powder daily for 2 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Isolated milk protein

Other Intervention Name(s)

PRODIET 85

Intervention Description

30-50g of protein powder daily for 2 weeks.

Primary Outcome Measure Information:

Title

Number of women in both arms with any pain of any type in operated breast or its vicinity

Time Frame

12 months post-surgery

Secondary Outcome Measure Information:

Title

Pain intensity (acute)

Time Frame

Up to 7 days post-surgery

Title

Pain intensity (chronic)

Time Frame

Up to 12 months post-surgery

Title

Analgesic medication use

Time Frame

Up to 12 months post-surgery

Title

Pain quality

Time Frame

Up to 12 months post-surgery

Title

Anxiety and Depression

Time Frame

Up to 12 months post-surgery

Title

Disability

Time Frame

Up to 12 months post-surgery

Title

Adverse events

Time Frame

2 weeks during dietary supplementation

Title

Childhood and adolescence consumption of soy

Time Frame

Baseline

Title

Adverse events

Time Frame

Up to 12 months post-surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoram Shir, MD

Organizational Affiliation

McGill University Health Centre/Research Institute of the McGill University Health Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Victoria Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

McGill University Health Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

Jewish General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

St. Mary's Hospital Center

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1M5

Country

Canada

12. IPD Sharing Statement

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

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