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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2026-01-14

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 chemotherapy for Haematological Cancer, 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 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.

Conditions

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Multiple Myeloma Olfactivo-gustatory Disorder Lymphoma Haematological Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

Multifactorial sensory rehabilitation workshops

Intervention Type OTHER

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

Intervention Type OTHER

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.

Group Type OTHER

Usual care

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0187

Identifier Type: -

Identifier Source: org_study_id

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