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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Multiple Myeloma, Olfactivo-gustatory Disorder, Lymphoma

Intervention / Treatment
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* Other: Multifactorial sensory rehabilitation workshops
* Other: Usual care
* Other: Tests and Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>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. | Other: Multifactorial sensory rehabilitation workshops<br>* 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.<br>Other: Tests and Questionnaire<br>* 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<br>|
| Other: Control<br>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. | Other: Usual care<br>* 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.<br>Other: Tests and Questionnaire<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 6 months | 
| Variation of Taste and Smell Survey score | Variation of the taste and Smell Survey score | up to 6 months | 
| 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. | Up to 6 months | 
| 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. | u pto 6 months | 
| Assessment of the physical activity | assessed by the score at GPAQ scale (Bull, Maslin, & Armstrong, 2009) | up to 6 months | 
| Variation of the patient weight | assessed by BMI between the beginning and the end of the study | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensory rehabilitation, utograft autologous stem cell transplantation, multiple myeloma, Melphalan, chemotherapy, taste, smell, quality of life, nutrition, lymphoma