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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276481
• Other study ID #: 17-404
• Status: Completed
• Start date: August 28, 2017
• Est. completion date: July 12, 2023

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of comprehensive chemical gustometry in participants with multiple myeloma undergoing autologous HCT	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

External Links

•   Memorial Sloan Kettering Cancer Center