The Effect of Soy Protein on Neuropathic Facial Pain

This study has suspended participant recruitment.
(Difficulty with recruitment)
Sponsor:
Collaborators:
Louise & Alan Edwards Foundation
Alan Edwards Centre for Research on Pain
Information provided by (Responsible Party):
Dr. Yoram Shir, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01050244
First received: January 14, 2010
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

Neuropathic facial pain is one form of chronic facial pain lacking effective pharmacotherapy. Interest in the role of complementary and alternative medicine is growing and diet is at the forefront of the search for alternative treatments for pain. Soy protein is one of the most promising dietary ingredients tested for its pain-relieving properties. Results from animal studies show that soy-enriched diets reduce pain due to nerve injury. The purpose of this study is to determine the effects of soy protein supplementation on facial pain.


Condition Intervention Phase
Neuralgic Facial Pain
Dietary Supplement: Isolated soy protein
Dietary Supplement: Isolated milk protein
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Soy Protein on Neuropathic Facial Pain: Randomized N-of-1 Trials

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Quality [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
  • Analgesic medication use [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: The full 18 weeks until the end of the last treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 33
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Soy Protein Dietary Supplement: Isolated soy protein
30-50 g of protein powder for 3 weeks
Other Names:
  • PRO-FAM 873
  • Code #066873
Placebo Comparator: Milk Protein Dietary Supplement: Isolated milk protein
30-50g of protein powder daily for 3 weeks
Other Name: PRODIET 85

Detailed Description:

Neuropathic facial pain is a complex disorder with mixed results in response to pain medication due to a high degree of variability between patients. To address this issue, we are implementing a unique methodology using a series of N-of-1 or single subject randomized, double blind, controlled studies. With this, we will explore the role of soy protein supplementation in neuropathic facial pain patients. Each patient will be exposed in 3-week intervals to soy protein and a control, milk protein, in three paired treatment periods for a total of 18 weeks. This method allows for the measurement of treatment efficacy in individual distinct patients and has the potential for immediate and continued medical benefit using a simple and readily available dietary ingredient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age ≥ 18 years old
  • Chronic neuropathic facial pain > 6 months
  • Suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary)
  • Pain intensity score ≥ 4 on a 10 cm visual analogue scale (VAS)
  • Stable medication use (if any) over 4 weeks before starting the trial. Current medication use will be maintained and no additional pharmacotherapy may be introduced during the trial.
  • Up to date mammogram and gynecological evaluations.

Exclusion Criteria:

  • History of significant heart, gastro-intestinal, liver or kidney disease
  • History of alcohol/narcotic abuse or current excessive alcohol consumption
  • History or diagnosis of cancer
  • History of breast tumors, predisposition to breast cancer or a family member with breast cancer
  • History of hormonal or gynaecological disease
  • Current use of hormonal replacement therapy (HRT), except thyroid HRT
  • Pregnant or breastfeeding women
  • Use of any anticoagulant or blood thinner except acetylsalicyclic acid
  • Malabsorption of any kind
  • Diagnosed lactase deficiency;
  • Known allergy to any of the dietary products
  • Daily consumption of soy protein in quantities exceeding 10 g/day
  • Strict vegetarians (i.e. no animal derived dietary sources)
  • Recent antibiotic use
  • Any previous psychiatric diagnosis before pain onset
  • Body mass index > 35
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050244

Locations
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Dr. Yoram Shir
Louise & Alan Edwards Foundation
Alan Edwards Centre for Research on Pain
Investigators
Principal Investigator: Yoram Shir, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr. Yoram Shir, Doctor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01050244     History of Changes
Other Study ID Numbers: GEN 09-117
Study First Received: January 14, 2010
Last Updated: July 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
Soy protein
Milk protein
Neuropathic

Additional relevant MeSH terms:
Facies
Facial Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014