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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03276481
Enrollment
47
Registered
2017-09-08
Start date
2017-08-28
Completion date
2023-07-12
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

melphalan, stem cell transplantation, 17-404, hematopoietic cell transplantation, HCT

Brief summary

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

Interventions

DIAGNOSTIC_TESTOral 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_TESTComprehensive 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.

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.

BEHAVIORALSurveys assessing taste disturbances

Surveys will be administered and examine taste disturbances pre and post HCT.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of comprehensive chemical gustometry in participants with multiple myeloma undergoing autologous HCTChange from baseline assessment up to 100 daysThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026