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

January 14, 2010
July 17, 2013
February 2011
August 2014   (final data collection date for primary outcome measure)
Pain Intensity [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01050244 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Throughout the study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Effect of Soy Protein on Neuropathic Facial Pain
The Effect of Soy Protein on Neuropathic Facial Pain: Randomized N-of-1 Trials

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuralgic Facial Pain
  • Dietary Supplement: Isolated soy protein
    30-50 g of protein powder for 3 weeks
    Other Names:
    • PRO-FAM 873
    • Code #066873
  • Dietary Supplement: Isolated milk protein
    30-50g of protein powder daily for 3 weeks
    Other Name: PRODIET 85
  • Experimental: Soy Protein
    Intervention: Dietary Supplement: Isolated soy protein
  • Placebo Comparator: Milk Protein
    Intervention: Dietary Supplement: Isolated milk protein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
33
December 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01050244
GEN 09-117
No
Dr. Yoram Shir, McGill University Health Center
Dr. Yoram Shir
  • Louise & Alan Edwards Foundation
  • Alan Edwards Centre for Research on Pain
Principal Investigator: Yoram Shir, MD McGill University Health Center
McGill University Health Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP