Clinical trial NCT04716153: Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer
Official title: Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Olfactivo-gustatory Disorder
Lymphoma
Haematological Cancer
Keywords: sensory rehabilitation
autograft autologous stem cell transplantation
multiple myeloma
chemotherapy
taste, smell
quality of life
nutrition
lymphoma
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: Proposition of a sensory rehabilitation program that could reduce the olfactory-gustatory alterations in patients who have been treated with chemotherapy for Haematological Cancer, 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 pathology 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 patients treated for Haematological cancer.

Hypothesis is that this sensory rehabilitation program should make it possible to reduce the olfactory-gustatory changes in patients who have been treated with Chemotherapy for Haematological cancer and significantly improve their quality of life, their psychological well-being and their nutrition.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and ≤ 75 years old
* Patient with olfactory or gustatory disorders
* Patient who has completed chemotherapy for haematological cancer

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®)
* 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
* 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

Primary outcomes:
measure: Assessment of the olfactometry
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of the gustometry
timeFrame: up to 6 months
measure: Variation of Taste and Smell Survey score
timeFrame: up to 6 months
measure: Assessment of the Quality of life
timeFrame: Up to 6 months
measure: Assessment of the Psychological distress
timeFrame: u pto 6 months
measure: Assessment of the physical activity
timeFrame: up to 6 months
measure: Variation of the patient weight
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hematology Department, University Hospital Center
Study officials:
affiliation: UH of Montpellier
name: Franciane PAUL, Dr.
role: STUDY_DIRECTOR
References: