Multiple MyelomaRE-NEZ-SENSNCT04716153
Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer
A study testing Multifactorial sensory rehabilitation workshops and Tests and Questionnaire in people with Multiple Myeloma and Olfactivo-gustatory Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Olfactivo-gustatory Disorder, Lymphoma
- What is being tested?
- Multifactorial sensory rehabilitation workshops and Tests and Questionnaire
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2021to 14 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and ≤ 75 years old
- Patient with olfactory or gustatory disorders
- Patient who has completed chemotherapy for haematological cancer
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hematology Department, University Hospital Center
Montpellier, 34 295
About this study
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.
Read the 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.
- Being tested
- Multifactorial sensory rehabilitation workshops, Usual care, Tests and Questionnaire
- Keywords
- sensory rehabilitation, autograft autologous stem cell transplantation, multiple myeloma, chemotherapy, taste, smell, quality of life, nutrition, lymphoma
- Medical subject headings
- Multiple Myeloma, Lymphoma, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial sensory rehabilitation workshopsOther
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 careOther
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 QuestionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 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. Receives: Other: Multifactorial sensory rehabilitation workshops; Other: Tests and Questionnaire |
| Control | 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.
Patients in the control group will be able to benefit from the rehabilitation workshops if they wish at the end of the study. Receives: Other: Usual care; Other: Tests and Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the olfactometry
Evolution of the Score of the "Sniffin'sticks" test from the initial score (V0), 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)
Measured: 3 months
Secondary outcomes (6)
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
Measured: up to 6 months
Variation of Taste and Smell Survey score
Variation of the taste and Smell Survey score
Measured: up to 6 months
Assessment of the Quality of life
Quality of life scores, obtained on the FACT-G scale. This is a 27-point self-administered questionnaire that measures the quality of life of patients with cancer. The FACT-G 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.
Measured: 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.
Measured: u pto 6 months
Assessment of the physical activity
assessed by the score at GPAQ scale (Bull, Maslin, \& Armstrong, 2009)
Measured: up to 6 months
Variation of the patient weight
assessed by BMI between the beginning and the end of the study
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start25 Jun 2021
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Why it stopped: Enrolement difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franciane PAUL, Dr., Study director, UH of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716153
- Sponsor's protocol ID
- RECHMPL20_0187
- Acronym
- RE-NEZ-SENS
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2021
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer
- ClinicalTrials.gov ID
- NCT04716153
- Acronym / sponsor ID
- RE-NEZ-SENS / RECHMPL20_0187
- Keywords
- sensory rehabilitation, autograft autologous stem cell transplantation, multiple myeloma, chemotherapy, taste, smell, quality of life, nutrition, lymphoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolement difficulties
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Multifactorial sensory rehabilitation workshops, Other: Tests and QuestionnairePatients 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. |
| Control | Other | Other: Usual care, Other: Tests and QuestionnaireThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and ≤ 75 years old
- Patient with olfactory or gustatory disorders
- Patient who has completed chemotherapy for haematological cancer
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifactorial sensory rehabilitation workshopsA 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. | Other | Interventional |
| Usual careThe 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 | Control |
| Tests and Questionnairefulfillment 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 | Other | Control, Interventional |
Primary outcome
Assessment of the olfactometry
Time frame: 3 months
Evolution of the Score of the "Sniffin'sticks" test from the initial score (V0), 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)
6 secondary outcomes
Assessment of the gustometry
Time frame: up to 6 months
Variation of Taste and Smell Survey score
Time frame: up to 6 months
Assessment of the Quality of life
Time frame: Up to 6 months
Assessment of the Psychological distress
Time frame: u pto 6 months
Assessment of the physical activity
Time frame: up to 6 months
Variation of the patient weight
Time frame: up to 6 months
Results and safety
The study was stopped early (reason given: Enrolement difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franciane PAUL, Dr. study director
UH of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial sensory rehabilitation workshops and Tests and Questionnaire in people with Multiple Myeloma and Olfactivo-gustatory Disorder, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrolement difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the olfactometry (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.