Prospective Evaluation of Taste Function In Multiple Myeloma Patients Undergoing Autologous Hematopoietic Cell Transplantation

Overview

The purpose of this study is to study taste disturbances on patients with myeloma who received high dose melphalan.

Full Title of Study: “Prospective Evaluation of Gustatory Function (Taste) In Patients Undergoing Autologous Hematopoietic Cell Transplantation for Multiple Myeloma”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 28, 2020

Interventions

  • Diagnostic Test: Oral microbiota assessment
    • Whole mouth microbiota will be assessed by having participants swish in their mouth 10 ml of sterile water for 30 sec and then expectorate in a sterile container. Specimens will be immediately placed on wet ice and transferred to the laboratory for processing or for storage at -80° C until they are ready to be prepared for sequencing.
  • Diagnostic Test: Comprehensive chemical gustometry
    • Chemical gustometry assessments will be performed by a trained clinician on the study team, including a Registered Dietitian, Physician’s Assistant, or Research Nurse. The test solutions and gradients will be formulated in house using sterile water and the following constituents: Sweet taste; 0.05, 0.1, and 0.2 g/ml sucrose, sour taste; 0.05, 0.09, and 0.165 g/ml citric acid, salty taste; 0.016, 0.04, and 0.1 g/ml NaCl and bitter taste; 0.0004, 0.0009, and 0.0024g/ml quinine-HCl. Umami will be tested with MSG at 25, 50, and 75 mM.
  • Diagnostic Test: Measurement of salivary flow
    • Both stimulated and un-stimulated salivation will be assessed by saliva collection in pre-weighed plastic containers. Participants will be seated with their back at a 90 degree angle and asked to swallow everything in their mouth. They will then be asked not to swallow and spit the accumulated saliva in the plastic container every 30 seconds for two minutes (unstimulated flow). For measurement of stimulated saliva, we will follow the same procedure except that after the initial swallow, participants will have their tongue swabbed twice with a cotton swab dipped in ascorbic acid solution or lemon juice.
  • Behavioral: Surveys assessing taste disturbances
    • Surveys will be administered and examine taste disturbances pre and post HCT.

Arms, Groups and Cohorts

  • Multiple Myeloma
    • Participants with multiple myeloma undergoing autologous hematopoietic cell transplantation (HCT) after a high dose melphalan conditioning regimen

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility of comprehensive chemical gustometry in participants with multiple myeloma undergoing autologous HCT
    • Time Frame: Change from baseline assessment up to 100 days
    • The primary objective of this protocol is to evaluate the feasibility of comprehensive chemical gustometry in participants with MM undergoing autologous HCT. Chemical gustometry will be evaluated at baseline and on days -1, 7, 14, 30 and 100.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 21 or above with diagnosis of multiple myeloma (myeloma is almost unheard of in patients less than 21 years of age).
  • Scheduled to receive conditioning chemotherapy with melphalan followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation
  • English or Spanish speaking
  • Calculated creatinine clearance > 40 mL/min

Exclusion Criteria

  • Prior head and neck radiation.
  • Severe periodontal infection. Poor oral hygiene and dentition as determined by pre HCT dental assessment.
  • Pregnancy
  • Patients with pre-existing moderate-severe dysgeusia

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sergio Giralt, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.