Haematological Cancer, Lymphoma, Multiple Myeloma, Olfactivo-gustatory Disorder
Conditions
Keywords
sensory rehabilitation, autograft autologous stem cell transplantation, multiple myeloma, chemotherapy, taste, smell, quality of life, nutrition, lymphoma
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.
Interventions
OTHERMultifactorial 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.
OTHERUsual 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.
OTHERTests 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
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the olfactometry | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the gustometry | up to 6 months | 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 |
| Variation of Taste and Smell Survey score | up to 6 months | Variation of the taste and Smell Survey score |
| Assessment of the Quality of life | Up to 6 months | 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. |
| Assessment of the Psychological distress | u pto 6 months | 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. |
| Assessment of the physical activity | up to 6 months | assessed by the score at GPAQ scale (Bull, Maslin, \& Armstrong, 2009) |
| Variation of the patient weight | up to 6 months | assessed by BMI between the beginning and the end of the study |
Countries
France
Contacts
STUDY_DIRECTORFranciane PAUL, Dr.
UH of Montpellier
Outcome results
None listed