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Helping Olfaction and Nutrition On Renal Replacement

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End Stage Renal Disease; Olfactory Disorders

Intervention: Theophylline (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Massachusetts General Hospital

Overall contact:
Sagar U. Nigwekar, MD, MMSc, Phone: 617 726 7872, Email: snigwekar@mgh.harvard.edu

Summary

This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients.

Clinical Details

Official title: Helping Olfaction and Nutrition On Renal Replacement

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change from baseline in smell identification test score at 6 weeks

Change from baseline in smell threshold test score at 6 weeks

Secondary outcome:

Change from baseline in serum albumin level at 6 weeks

Change from baseline in serum prealbumin level at 6 weeks

Change from baseline in serum triglyceride level at 6 weeks

Change from baseline in serum transferrin level at 6 weeks

Change from baseline in nasal mucus cAMP level at 6 weeks

Change from baseline in salivary cAMP level at 6 weeks

Change from baseline in nasal mucus cGMP level at 6 weeks

Change from baseline in salivary cGMP level at 6 weeks

Change from baseline in plasma theophylline level at 6 weeks

Detailed description: Malnutrition and cachexia are prevalent in end stage renal disease (ESRD) patients and are associated with increased morbidity and mortality. Food aversion is a major contributor to anorexia and malnutrition in ESRD and it also impacts the quality of life. Olfactory dysfunction has been shown to contribute to food aversion in ESRD patients. Since up to 80% of a meal's flavor is attributed to olfactory input, loss or alteration of smell leads to loss or alteration of taste in ESRD patients and at present there are no effective therapies to treat smell and/or taste disorders in ESRD patients. In patients with other causes of olfactory dysfunction such as congenital hyposmia and traumatic brain injury, intranasal theophylline has been shown to be effective in improving olfactory defects via increasing nasal mucus levels of cAMP and cGMP, second messengers critical for optimal smell sensation. However, the efficacy of nasal theophylline to improve olfaction in ESRD patients has not been investigated and the effects of nasal theophylline treatment on the nutritional parameters are unknown in ESRD patients. Aim: To examine the efficacy and safety of nasal theophylline treatment to improve olfaction and nutrition in ESRD patients Hypothesis: Nasal theophylline treatment improves olfaction and nutrition in ESRD patients with olfactory defects by via increasing intracellular cAMP and cGMP levels. A previous pilot clinical trial demonstrated that intranasal theophylline is safe and effective in improving olfactory deficits in congenital hyposmia and traumatic brain injury, however, it has not been examined in ESRD patients. The investigators will conduct a pilot single arm open-label clinical trial (n=20) of 6 weeks duration to examine the efficacy and safety of nasal theophylline in hemodialysis-dependent ESRD patients with olfactory defects. The investigators will examine whether nasal theophylline improves olfaction and nutritional status in trial participants.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ESRD requiring chronic outpatient hemodialysis

- Able to provide written consent

- Defects in smell identification and/or smell threshold detection as measured by

"Scratch-and-sniff" University of Pennsylvania Smell Identification Test (UPSIT) and Smell Threshold Test Exclusion Criteria:

- Prior allergic reaction to theophylline

- Patients currently treated with theophylline for clinical indication

- Pregnancy or lactation

- ESRD patients on peritoneal dialysis

- Patients hospitalized at the time of study enrollment

Locations and Contacts

Sagar U. Nigwekar, MD, MMSc, Phone: 617 726 7872, Email: snigwekar@mgh.harvard.edu

Additional Information

Related publications:

Henkin RI, Velicu I, Schmidt L. An open-label controlled trial of theophylline for treatment of patients with hyposmia. Am J Med Sci. 2009 Jun;337(6):396-406. doi: 10.1097/MAJ.0b013e3181914a97.

Henkin RI, Schultz M, Minnick-Poppe L. Intranasal theophylline treatment of hyposmia and hypogeusia: a pilot study. Arch Otolaryngol Head Neck Surg. 2012 Nov;138(11):1064-70. doi: 10.1001/2013.jamaoto.342.

Starting date: August 2015
Last updated: June 19, 2015

Page last updated: August 23, 2015

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