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

July 13, 2023 updated by: Memorial Sloan Kettering Cancer Center

Prospective Evaluation of Gustatory Function (Taste) In Patients Undergoing Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study subjects will be identified by the Adult Bone Marrow Transplant team. They are usually identified in clinic when a treatment plan that includes conditioning chemotherapy has been scheduled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiple Myeloma
Participants with multiple myeloma undergoing autologous hematopoietic cell transplantation (HCT) after a high dose melphalan conditioning regimen
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline assessment up to 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Sergio Giralt, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2017

Primary Completion (Actual)

July 12, 2023

Study Completion (Actual)

July 12, 2023

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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