search
Back to results

Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Autografted Patients Treated With Melphalan (RE-NEZ-SENS)

Primary Purpose

Multiple Myeloma, Olfactivo-gustatory Disorder, Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multifactorial sensory rehabilitation workshops
Usual care
Tests and Questionnaire
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Myeloma focused on measuring sensory rehabilitation, utograft autologous stem cell transplantation, multiple myeloma, Melphalan, chemotherapy, taste, smell, quality of life, nutrition, lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and ≤ 75 years old
  • Autograft for Multiple Myeloma (MM) or lymphoma

  • Olfactory-gustatory complaint objectified by a positive answer to question 1 or 2, and to question 3:

    1. / Have you noticed any changes in your sense of taste or smell?
    2. / Have you ever noticed that a food tastes or smells different from usual?
    3. / Would you say that changes in your sense of taste or smell are affecting your quality of life?

Exclusion Criteria:

  • Eating disorder known prior to anti-cancer treatment, bulimic, anorexic or binge eating disorder (DSM-V criteria)
  • Refusal to sign the free and informed consent
  • Hypersensitivity to one of the components of liposomal sprays (Liposaliva® or liponasal®)
  • Double autograft
  • COVID + patient in the previous 3 months
  • Performance status ECOG 3 or 4
  • Patient included in another clinical trial modifying taste / olfaction
  • Artificial nutrition post-chemotherapy
  • Known food allergies
  • Resident more than 80 km from the technical center (Mas de Saporta, Lattes)
  • Having a reading level in French that may interfere with a good understanding of the protocol and the questionnaires
  • Presenting visual or hearing deficits uncorrected to normal and which may affect the proper completion of the questionnaires
  • Patient under curatorship or tutorship.
  • Patient deprived of liberty
  • Pregnant or breastfeeding patient
  • Not be affiliated with a French social security scheme or beneficiary of such a scheme

Sites / Locations

  • Hematology Department, University Hospital CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Interventional

Control

Arm Description

Patients in the interventional arm will follow a multifactorial sensory rehabilitation program focused on smell and taste that integrates several non-drug interventions, which are part of the current recommendations: program of workshops at the technical center, hydration of the mucous membranes with daily (3 times a day) liposomal sprays (LipoSaliva® and LipoNasal) between V0 and V1, presentation of visual dishes. The workshops will take place at the frequency of one session of 2 hours per week and will last for 3 weeks. Each session will accommodate 6 to 10 participants. The program will include 3 workshops on olfactory rehabilitation and taste rehabilitation. Exercises (taking up the themes discussed) will be carried out at home between 2 workshops.

The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat. The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified.

Outcomes

Primary Outcome Measures

Assessment of the olfactometry
Evolution of the Score of the "Sniffin'sticks" test, which itself includes an olfactory discrimination, olfactory threshold and olfactory identification score (with a cut-off of ≤ 15 for anosmia, ≥ for normonosmia and hypoanosmia for a score between 15 and 30)

Secondary Outcome Measures

Assessment of the gustometry
Score in the "Taste Strips" test, Hypoageusia scores being for participants aged 18 to 40, <19 for women and <17 for men; for participants aged 41 to 60, score <15 for women and 9 for men; for participants over 60, score <10.2 for women and <9 for men
Variation of Taste and Smell Survey score
Variation of the taste and Smell Survey score
Assessment of the Quality of life
Quality of life scores, obtained on the FACT-BMT scale. This is a 47-point self-administered questionnaire that measures the quality of life of patients undergoing a bone marrow transplant. The FACT-BMT measures physical, functional, social / family factors, and emotional well-being as well as physician / patient relationship satisfaction and concerns. All items are rated on a 5-point Likert scale based on the week prior to the assessment.
Assessment of the Psychological distress
The psychological distress score objectified by the Hospital Anxiety Depression Scale (HADS). This self-questionnaire, validated in French, contains 14 items. It is simple, sensitive and specific. It has been validated in cancer patients, that it is rapid (completion time around 5 minutes), and allows the calculation of 2 sub-scores for anxiety and depression in addition to an overall level. Finally, this tool is sensitive to changes both during the course of medical illnesses and in response to psychopharmacological interventions.
Assessment of the physical activity
assessed by the score at GPAQ scale (Bull, Maslin, & Armstrong, 2009)
Variation of the patient weight
assessed by BMI between the beginning and the end of the study

Full Information

First Posted
January 15, 2021
Last Updated
December 31, 2021
Sponsor
University Hospital, Montpellier
search

1. Study Identification

Unique Protocol Identification Number
NCT04716153
Brief Title
Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Autografted Patients Treated With Melphalan
Acronym
RE-NEZ-SENS
Official Title
Impact of a Multifactorial Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Autografted Patients Treated With Melphalan for Multiple Myeloma or Lymphoma : a Single-center, Randomized,Crontrolled Study, With 2 Parallel Arms.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Proposition of a sensory rehabilitation program that could reduce the olfactory-gustatory alterations in patients who have been treated with Melphalan for therapeutic intensification with autologous transplantation of hematopoietic stem cells for multiple myeloma or lymphoma, and also improve their life quality, psychological well-being, and nutrition.
Detailed Description
Disturbances in taste and smell affect a considerable proportion of patients treated with chemotherapy. In hematology, dysgeusia depends on the type of graft and the treatments themselves. It impacts the quality of life, leads to significant emotional and social consequences, affects the intake, weight and nutritional status of patients. Olfactory-taste disorders can be assessed using subjective and objective tests. There are no international clinical recommendations for the management of taste and olfactory disturbances associated with chemotherapy in hematological cancers. Also, this study proposes to evaluate a taste and olfaction rehabilitation program based on national standards and recent research. It will help fill gaps in the assessment and management of autografted patients treated with high-dose Melphalan. Hypothesis is that this sensory rehabilitation program should make it possible to reduce the olfactory-gustatory changes in patients who have been treated with Melphalan and significantly improve their quality of life, their psychological well-being and their nutrition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Olfactivo-gustatory Disorder, Lymphoma
Keywords
sensory rehabilitation, utograft autologous stem cell transplantation, multiple myeloma, Melphalan, chemotherapy, taste, smell, quality of life, nutrition, lymphoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Ramdonized, controlled study with 2 parallel arms (interventional and control). Patients in the interventional arm will follow a multi-factor sensory rehabilitation program focused on smell and taste with daily use (3 times a day) of Liposomal sprays (LipoSaliva® : mouth and LipoNasal® : nose) between V0 and V1. The control group will only receive the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
Patients in the interventional arm will follow a multifactorial sensory rehabilitation program focused on smell and taste that integrates several non-drug interventions, which are part of the current recommendations: program of workshops at the technical center, hydration of the mucous membranes with daily (3 times a day) liposomal sprays (LipoSaliva® and LipoNasal) between V0 and V1, presentation of visual dishes. The workshops will take place at the frequency of one session of 2 hours per week and will last for 3 weeks. Each session will accommodate 6 to 10 participants. The program will include 3 workshops on olfactory rehabilitation and taste rehabilitation. Exercises (taking up the themes discussed) will be carried out at home between 2 workshops.
Arm Title
Control
Arm Type
Other
Arm Description
The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat. The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified.
Intervention Type
Other
Intervention Name(s)
Multifactorial sensory rehabilitation workshops
Intervention Description
A multifactorial sensory rehabilitation Workshops : a multifactorial program in order to optimize the recovery of flavors, focused on smell and taste which integrates several non-drug interventions, which are part of the current recommendations: hydration of the mucous membranes with daily (3 times a day) liposomal sprays (nose and mouth), presentation of visual dishes.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat. The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified.
Intervention Type
Other
Intervention Name(s)
Tests and Questionnaire
Intervention Description
fulfillment of Taste Strips Test, Sniffin'sticks test and FACT-BMT, HADS, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients
Primary Outcome Measure Information:
Title
Assessment of the olfactometry
Description
Evolution of the Score of the "Sniffin'sticks" test, which itself includes an olfactory discrimination, olfactory threshold and olfactory identification score (with a cut-off of ≤ 15 for anosmia, ≥ for normonosmia and hypoanosmia for a score between 15 and 30)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assessment of the gustometry
Description
Score in the "Taste Strips" test, Hypoageusia scores being for participants aged 18 to 40, <19 for women and <17 for men; for participants aged 41 to 60, score <15 for women and 9 for men; for participants over 60, score <10.2 for women and <9 for men
Time Frame
up to 6 months
Title
Variation of Taste and Smell Survey score
Description
Variation of the taste and Smell Survey score
Time Frame
up to 6 months
Title
Assessment of the Quality of life
Description
Quality of life scores, obtained on the FACT-BMT scale. This is a 47-point self-administered questionnaire that measures the quality of life of patients undergoing a bone marrow transplant. The FACT-BMT measures physical, functional, social / family factors, and emotional well-being as well as physician / patient relationship satisfaction and concerns. All items are rated on a 5-point Likert scale based on the week prior to the assessment.
Time Frame
Up to 6 months
Title
Assessment of the Psychological distress
Description
The psychological distress score objectified by the Hospital Anxiety Depression Scale (HADS). This self-questionnaire, validated in French, contains 14 items. It is simple, sensitive and specific. It has been validated in cancer patients, that it is rapid (completion time around 5 minutes), and allows the calculation of 2 sub-scores for anxiety and depression in addition to an overall level. Finally, this tool is sensitive to changes both during the course of medical illnesses and in response to psychopharmacological interventions.
Time Frame
u pto 6 months
Title
Assessment of the physical activity
Description
assessed by the score at GPAQ scale (Bull, Maslin, & Armstrong, 2009)
Time Frame
up to 6 months
Title
Variation of the patient weight
Description
assessed by BMI between the beginning and the end of the study
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and ≤ 75 years old Autograft for Multiple Myeloma (MM) or lymphoma Olfactory-gustatory complaint objectified by a positive answer to question 1 or 2, and to question 3: / Have you noticed any changes in your sense of taste or smell? / Have you ever noticed that a food tastes or smells different from usual? / Would you say that changes in your sense of taste or smell are affecting your quality of life? Exclusion Criteria: Eating disorder known prior to anti-cancer treatment, bulimic, anorexic or binge eating disorder (DSM-V criteria) Refusal to sign the free and informed consent Hypersensitivity to one of the components of liposomal sprays (Liposaliva® or liponasal®) Double autograft COVID + patient in the previous 3 months Performance status ECOG 3 or 4 Patient included in another clinical trial modifying taste / olfaction Artificial nutrition post-chemotherapy Known food allergies Resident more than 80 km from the technical center (Mas de Saporta, Lattes) Having a reading level in French that may interfere with a good understanding of the protocol and the questionnaires Presenting visual or hearing deficits uncorrected to normal and which may affect the proper completion of the questionnaires Patient under curatorship or tutorship. Patient deprived of liberty Pregnant or breastfeeding patient Not be affiliated with a French social security scheme or beneficiary of such a scheme
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franciane PAUL, Dr.
Phone
0033467338260
Email
f-paul@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Estelle GUERDOUX-NINOT, PhD
Phone
0033467612468
Email
estelle-guerdoux-ninot@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franciane PAUL, Dr.
Organizational Affiliation
UH of Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
Hematology Department, University Hospital Center
City
Montpellier
ZIP/Postal Code
34 295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franciane PAUL, Dr
Phone
04 67 33 82 63
Ext
+33
Email
f-paul@chu-montpellier.fr

12. IPD Sharing Statement

Learn more about this trial

Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Autografted Patients Treated With Melphalan

We'll reach out to this number within 24 hrs