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

NCT ID: NCT03276481

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-28
• Study Completion Date: 2023-07-12

Brief Summary

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

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Multiple Myeloma

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

Oral microbiota assessment

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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.

Surveys assessing taste disturbances

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Surveys assessing taste disturbances

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergio Giralt, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

17-404

Identifier Type: -

Identifier Source: org_study_id