Clinical trial NCT02479451: Helping Olfaction and Nutrition On Renal Replacement
Official title: Helping Olfaction and Nutrition On Renal Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Olfactory Disorders
Keywords: End stage renal disease
Olfaction
Dialysis
Hemodialysis
Malnutrition
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Change From Baseline in Smell Identification Test Score at 6 Weeks
timeFrame: Baseline and every 2 weeks for 6 weeks
measure: Change From Baseline in Smell Threshold Test Score at 6 Weeks
timeFrame: Baseline and every 2 weeks for 6 weeks
Secondary outcomes:
measure: Change From Baseline in Plasma Theophylline Level at 6 Weeks
timeFrame: Baseline and every 2 weeks for 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sagar U Nigwekar, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.