Assess the efficacy of PBMT to prevent/ameliorate dysgeusia in patients with multiple myeloma treated in Amsterdam UMC with conditioning chemo(radio)therapy followed by autologous stem-cell-transplantation.
ID
Source
Brief title
Condition
- Other condition
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Health condition
mond aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective taste function
Secondary outcome
Subjective taste function
Presence and severity of hyposalivation
Presence and severity of xerostomia
Patient reported oral mucositis
Global and oral health-related QoL
Patient reported oral health
Caloric/dietary intake
Background summary
In 2020, 115,000 Dutch patients were diagnosed with cancer. Up to 85% of
patients treated with radiotherapy involving the head and neck, chemotherapy or
stem-cell-transplantation (SCT) suffer from taste disorders (dysgeusia).
Dysgeusia is one of the most distressing adverse effects of cancer therapy, may
be long-lasting and may contribute to malnutrition and decreased QoL. Dysgeusia
pathobiology is complex and relates to direct damage to taste buds by
anticancer therapies, neuropathy and/or mucosal infection and inflammation.
Hyposalivation and concurrent medications may also play a role as well as
smoking and poor oral health. Zinc suppletion, clonazepam and
delta-9-tetrahydrocannabionol have only limited success. Thus, dysgeusia in
cancer patients represents a significant unmet clinical need.
Photobiomodulation therapy (PBMT) using specific wavelengths of
red/near-infrared light reduces oxidative stress and increases ATP in cells,
which improves cell metabolism and reduces inflammation. PBMT is safe and
effective for the prevention of oral mucositis and is linked to pain reduction,
nerve damage recovery and improved wound healing. There is emerging evidence
for PBMT to improve taste, likely based on its regenerative effects on taste
buds and nerves involved in taste function. However, there is need for more
reliable data on the effect of PBMT on taste.
Study objective
Assess the efficacy of PBMT to prevent/ameliorate dysgeusia in patients with
multiple myeloma treated in Amsterdam UMC with conditioning chemo(radio)therapy
followed by autologous stem-cell-transplantation.
Study design
Phase 2, single centre, prospective, longitudinal, double-blinded, randomized,
controlled study.
Intervention
Patients will be blinded to receive either PBMT or sham-PBMT.
Study burden and risks
Patients will be seen at the same time that they have a regular appointment in
the hospital. The patient reported outcomes are also filled out at several time
points during hospitalization. No invasive procedures are performed. The
intervention comes with no risks. Possible less taste complications after
treatment.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients diagnosed with multiple myeloma; 18 years of age receiving HDM
followed by SCT
Exclusion criteria
Having taste disorders not related to SCT (e.g. COVID-19)
History of a head and neck tumor treated with surgery and/or (chemo)radiation
Neurological diseases (e.g. Parkinson*s disease)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84772.018.23 |