The aim of this pilot is to get an impression of the feasibility and added value of administering deep sound waves to the body during (neo) adjuvant chemotherapy. In addition, we want to gain insight into whether or not complete completion of a…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Health condition
neuropathische aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In order to assess whether neuropathy has developed after the last
chemotherapy, the primary endpoint was chosen 3 months after the last
treatment. The number of fully / dosed courses, prevention of neuropathy
(measured according to current guidelines in the department and measured with
the FACT / GOG-NTX-13 questionnaire), use of medication against neuropathy and
the experience of patients with DSWT (questionnaire Numerical Rating Scales /
open questions are registered
Secondary outcome
nvt
Background summary
The treatment of colorectal and breast carcinoma with (adjuvant) chemotherapy
leads to neuropathy in more than 80% of the patients (even * 92% in colorectal
carcinoma). These complaints are so serious that chemotherapy can not be
completed according to the original schedule. For the above reasons, there is
an urgent need for new innovations that can reduce or prevent side effects, so
that patients have fewer complaints and complete dosing schedules. This
innovation is now possible in the form of Deep Sound Wave Therapy (DSWT). In
this non-invasive treatment, patients sit in a chair where, during the course
of the chemotherapy, treatment programs consisting of low-frequency sound waves
(25-100 Hz) are administered to the body. Although the mechanism of action is
still insufficiently known, results from a first (not yet published) study in
the US suggest that this treatment has an added value in the reduction of
symptoms due to neuropathy.
Study objective
The aim of this pilot is to get an impression of the feasibility and added
value of administering deep sound waves to the body during (neo) adjuvant
chemotherapy. In addition, we want to gain insight into whether or not complete
completion of a chemotherapy, reducing the incidence of neuropathies and the
use of medication against neuropathy, and the experience of patients with this
new treatment. In addition, these studies are collected that can be used to
calculate a sample size for future studies.
Study design
A non-invasive pilot / feasibility study in which the results are compared with
two historical cohorts
Intervention
During the CapOX / AC-P treatment, test subjects take place on the DSWT chair
instead of on a regular chair and receive specific DSWT treatments in that
chair.
Study burden and risks
DSWT is applied during the regular administration of the chemotherapy
(including other medication). In addition, participants have to go to the
hospital for an extra 1x for the DSWT treatment (frequency + duration). If DSWT
has an added value then patients can complete the chemotherapy according to the
original schedule, they have fewer complaints of neuropathy and the use of
medication for neuropathy decreases. Until now there are no negative effects on
the chemotherapy treatment known.
Dr. Deenweg 1-11
8025Bp, Zwolle 8025BP
NL
Dr. Deenweg 1-11
8025Bp, Zwolle 8025BP
NL
Listed location countries
Age
Inclusion criteria
subjects who will start adjuvant chemotherapy in the form of CapOx or Paclitaxel.
subjects in the age of >18 year
Exclusion criteria
subjects with a pacemaker
subjects with a weight greater than 140 kg.
subjects previously treated with neurotoxic medication
Patients with active rheumatoid arthritis.
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 | NL64994.075.18 |