NCT01047774

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_2 pain

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

3.2 years

First QC Date

January 12, 2010

Last Update Submit

October 5, 2015

Conditions

PainChronic DiseaseBreast Cancer

Keywords

soy proteindiet

Outcome Measures

Primary Outcomes (1)

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

    12 months post-surgery

Secondary Outcomes (9)

  • Pain intensity (acute)

    Up to 7 days post-surgery

  • Pain intensity (chronic)

    Up to 12 months post-surgery

  • Analgesic medication use

    Up to 12 months post-surgery

  • Pain quality

    Up to 12 months post-surgery

  • Anxiety and Depression

    Up to 12 months post-surgery

  • +4 more secondary outcomes

Study Arms (2)

Soy protein

EXPERIMENTAL
Dietary Supplement: Isolated soy protein

Milk protein

PLACEBO COMPARATOR
Dietary Supplement: Isolated milk protein

Interventions

Isolated soy proteinDIETARY_SUPPLEMENT

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

Also known as: PRO-FAM 873, Code #066873
Soy protein
Isolated milk proteinDIETARY_SUPPLEMENT

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

Also known as: PRODIET 85
Milk protein

Eligibility Criteria

Age21 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

MeSH Terms

Conditions

PainChronic DiseaseBreast Neoplasms

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • Yoram Shir, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

CA(4)