Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05448209 |
| Other study ID # |
198411013011 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2022 |
| Est. completion date |
October 6, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Necmettin Erbakan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Peripheral neuropathy from paclitaxel is a cause for concern. This situation also affects the
patient, family and healthcare professionals. All health personnel are responsible for its
care. With this study, it will be possible to create evidence for nursing practices and
increase the quality of life by relieving symptoms.
Description:
Unique value of the project: Chemotherapy Induced Peripheral Neuropathy (CIPN) is one of the
most common side effects of chemotherapeutic agents. CIPN is a frequently dose-limiting
neurotoxicity that causes significant deterioration in patients' quality of life. The
development of chemotherapy-induced peripheral neuropathy has not been fully explained. Due
to the increasing survival rates of cancer patients, paclitaxel-induced neurotoxicity has
become a growing epidemiological problem. In a systematic review to identify metabolic and
lifestyle risk factors for chemotherapy-induced peripheral neuropathy in patients treated
with taxane and platinum; it has been shown that the overall incidence of neuropathy varies
between 16.9% and 89.4%. However, growing evidence suggests that exercise may help reduce
CIPN. Specifically, the most evidence supports that moderate to vigorous aerobic exercise
combined with strength and/or balance training in the clinic and at home can reduce CIPN
during and after chemotherapy treatment. Physical exercise can attenuate CIPN through its
effect on blood circulation/oxidative stress, inflammation, neurotransmitters, endogenous
opioids, growth factors, neuroplasticity and coping, symptom interaction mechanisms.
Treatment with taxane-containing chemotherapy regimens is crucial to improve overall and
disease-free survival in patients with early-stage invasive breast cancer. However, taxane
treatment may cause pain. Although the incidence of taxane-induced pain is inconsistent in
the literature, nonspecific pain has been described in 50-78% of patients receiving taxane
therapy. Myalgia and/or arthralgia experienced by patients receiving taxane-based
chemotherapy may result in impaired mobility secondary to limitation of joint function, and
the experience of pain may affect physical function. The beginnings of nursing theories were
developed to form the foundations of nursing science through the production of
profession-specific knowledge. Theories consist of concepts and statements that aim to
explain or categorize phenomena related to a field of knowledge. Theory of Unpleasant
Symptoms (TOUS) arises from the belief that there are common points between different
symptoms. This theory allows nurses to know different symptom groups so they can recommend
non-pharmacological interventions to patients.
Method: The project was planned as a prospective, single-blind, randomized controlled
experimental type.
Management: Motivational interviewing is an important component of the walking intervention.
Specific objectives are to evaluate the impact of gait intervention with Motivational
interviewing on; CIPN severity and To evaluate the effect of walking exercise alone on
arthralgia-myalgia at 12 weeks compared with standard training in breast cancer patients
receiving paclitaxel.
Application
- At the stage of implementation, patients receiving Paclitaxel-Paclitaxel-Herceptin
chemotherapy protocol sent by the City Hospital Medical Oncology Specialist will be
interviewed and the purpose of the research will be explained and written/verbal consent
will be obtained. Consent will be taken in the Oncology Training Nurse room. Patients
who accept the study will be evaluated in terms of inclusion and exclusion criteria.
- Personal information form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool,
McGill Melzack Pain Questionnaire, Modified BORG Scale, ECOG Performance Scale will be
evaluated by interview method at the beginning of the patients who accept the study.
- Afterwards, a nurse-led Motivational Interview will be held about CIPN, physical
activity and regular physical activity-walking for patients taking
paclitaxel-paclitaxel-herceptin. Patients will be informed about the study and their
written consent will be obtained.
- They will be told to walk at a moderate intensity, usually defined as the BORG Scale of
4 to 5 perceived effort, three to five days a week to start with 10 minutes initially,
then continue until they reach 30 or 60 minutes, 3 times a week. Patients will be
instructed that the goal is to exceed the previous number of steps each time.
- Participants will be informed that if they feel fatigue, lethargy, balance problems,
pain, palpitations throughout the day, they can do their exercise the next day.
- If he/she has trouble/shortness of breath, chest pain, palpitation complaints during
walking, he/she will be told to take a break from walking and rest. The study will be
conducted under the supervision of a Medical Oncology specialist throughout the study,
as well as the controls of patients with ongoing symptoms.
- Participants will be given a pedometer for regular follow-up, its use will be explained
and they will be told to mark it on the walking tracking chart. How to register will be
explained. The initial step count will be recorded as the number of steps recorded on
the first day the patient used the pedometer.
- It will be emphasized that rhythmic walking is important for the pedometer to count
correctly.
- What Is Your Biggest Physical Activity Barrier? Do you forget to be physically active?
For example, if a participant's biggest obstacle is forgetting to walk, the expression
of intent might be: "If it's six o'clock on Saturday, then I'll walk for 10 minutes." If
then the application notification form.
- Motivational Interview sessions will be conducted face-to-face at the beginning, week 4
and week 8.
- Intervention participants will be added to a Watsap group and invited to weekly group
walk events with other intervention group participants.
- They will receive a weekly written motivational message and will be encouraged to join
the WhatsApp discussion.
Control Group
- Patients in the control group will receive routine training given by Oncology Education
Nursing.
- Personal information form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
(CIPNAT), McGill Melzack Pain Questionnaire, Modified BORG Scale, ECOG Performance in
the intervention and control group by a specialist nurse at week 0, week 4, week 8, and
week 12 The scale will be evaluated.
- Continuously recorded step numbers in the Intervention and Control group 0.4.8. and will
be evaluated for analysis, taking into account the last measurements of the 12th week.
- A special exercise prescription, namely MG-Walking intervention support, will not be
provided to control group participants. Telephone follow-up (to assess adverse events)
will take place. After the completion of the training, a supervised walking exercise
will be offered to the participants if they wish.
Widespread effect: This study will contribute to the literature and will have a significant
impact on the quality of life of many cancer patients and cancer survivors.
