Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer
NCT ID: NCT04716153
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2021-06-25
2026-01-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
NONE
Study Groups
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Interventional
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 a minimum of 2 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.
Multifactorial sensory rehabilitation workshops
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.
Tests and Questionnaire
fulfillment of Taste Strips Test, Sniffin'sticks test and QGO, FACT-G, HADS, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients
Control
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.
Patients in the control group will be able to benefit from the rehabilitation workshops if they wish at the end of the study.
Usual care
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.
Tests and Questionnaire
fulfillment of Taste Strips Test, Sniffin'sticks test and QGO, FACT-G, HADS, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients
Interventions
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Multifactorial sensory rehabilitation workshops
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.
Usual care
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.
Tests and Questionnaire
fulfillment of Taste Strips Test, Sniffin'sticks test and QGO, FACT-G, HADS, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients
Eligibility Criteria
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Inclusion Criteria
* Patient with olfactory or gustatory disorders
* Patient who has completed chemotherapy for haematological cancer
Exclusion 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
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Franciane PAUL, Dr.
Role: STUDY_DIRECTOR
UH of Montpellier
Locations
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Hematology Department, University Hospital Center
Montpellier, , France
Countries
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Other Identifiers
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RECHMPL20_0187
Identifier Type: -
Identifier Source: org_study_id
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