Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04843410 |
| Other study ID # |
13022260-300-180785 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
August 30, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Istanbul University - Cerrahpasa (IUC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chemotherapy-associated peripheral neuropathy is a common complication in patients receiving
taxane and platinum-based chemotherapy. Peripheral neuropathy may cause the patient's daily
life activities to be hindered, quality of life to deteriorate, treatment dose reduced, or
even discontinuation of treatment. In the literature, different studies have been carried out
using many pharmacological and non-pharmacological approaches in the management of this
problem, but so far, any approach that has been shown to be effective in its management has
not been clearly defined. One of the approaches whose effectiveness is evaluated in
management is exercise. There have been published case reports and several experimental
studies examining small patient groups on this subject, and it has been shown to have
significant benefits in the management of peripheral neuropathy. This study was planned to
determine whether exercise is an effective method in the management of
chemotherapy-associated peripheral neuropathy in oncology patients.
Description:
Chemotherapy-associated peripheral neuropathy is a common complication in patients undergoing
taxane and platinum-based chemotherapy. Peripheral neuropathy may cause the patient's
activities of daily living to be inhibited, deterioration of quality of life, reduction of
treatment dose, and even discontinuation of treatment. In the literature, different studies
have been carried out using many pharmacological and non-pharmacological approaches to manage
this problem, but no approach that has been shown to be effective in its management has not
been clearly defined until now. One of the approaches whose effectiveness is evaluated in
management is exercise. Published case reports and a few experimental studies examining small
patient groups have been found to have significant benefits in the management of peripheral
neuropathy. This study was planned to determine whether exercise is effective in managing
associated peripheral neuropathy in oncology patients.
General Information Cancer is one of the most important health problems in the world and our
country. Despite significant developments in cancer treatment, treatment-related side effects
can lead to adverse effects on the quality of life of patients, limitation of their
activities, and even restriction of the treatment dose and discontinuation of the treatment,
which may adversely affect the response of the patient to treatment.
Antineoplastic agents used in cancer treatment provide treatment of cancer or prevent its
progression by preventing the division and proliferation of cancer cells. However, these
drugs cause many important side effects such as anemia, diarrhea, nausea, vomiting,
infections, fatigue, alopecia, infertility, pain, and peripheral neuropathy in the patient by
affecting not only cancer cells but also normal cells and body structures.
Peripheral neuropathy is a significant side effect that adversely affects patients' quality
of life receiving taxane or platinum-based chemotherapy. The incidence of
chemotherapy-associated peripheral neuropathy varies between 19 and 85%, depending on the
type of chemotherapy protocol administered, the drug dose used in the treatment, and the
duration of administration. The incidence of peripheral neuropathy, according to the type of
antineoplastic agent applied, is between 70-100% in platinum-administered patients, 11-87% in
taxane-administered patients, 20-60% in thalidomide-administered patients, and 60-65% in
ixabepilone-administered patients. The most common antineoplastic agents causing peripheral
neuropathy are platinum (oxaliplatin and cisplatin), vinca alkaloids (vincristine and
vinblastine), and taxanes (paclitaxel, docetaxel), proteasome inhibitors (bortezomib), and
immunomodulatory drugs (thalidomide). These chemotherapeutic agents, which cross the
blood-brain barrier, affect the dorsal root ganglia and peripheral axons in the spinal cord,
causing changes in motor, sensory and autonomic neurons, causing the development of
peripheral neuropathy.
Many factors such as age, concomitant diabetes mellitus history, microtubules or
mitochondrial damage, oxidative stress, changes in ion channel activity, and damage to the
myelin sheath play a role in the development of peripheral neuropathy. Sensory, motor, and
autonomic symptoms may develop in patients with chemotherapy-related peripheral neuropathy.
First, patients develop sensory symptoms such as numbness in the hands and feet, tingling,
change in the sense of touch, paresthesia, dysesthesia, and patients usually describe these
sensory changes as a feeling of wearing gloves and socks. As the picture progresses,
spontaneous burning, fever, electric shock, mechanical or thermal allodynia, and hyperalgesia
may also develop in patients. In severe cases, these symptoms can go as far as loss of
sensory perception. Muscle weakness, gait, and balance disorders that increase the risk of
falling are frequently reported motor symptoms by patients. Orthostatic hypotension,
constipation, urinary dysfunction, and sexual dysfunction are common autonomic symptoms in
patients. While these symptoms improve over time with the discontinuation of chemotherapy in
some patients, they can be permanent because neuron damage occurs in most patients.
Therefore, approaches presented in the management of peripheral neuropathy in the literature
are quite limited.
In a systematic review of the effectiveness of pharmacological approaches in the management
of chemotherapy-associated peripheral neuropathy, it was reported that the use of
pharmacological agents such as duloxetine, gabapentin, acetyl-L-carnitine (ALC),
amitriptyline, cannabinoid, lamotrigine, and topical baclofen could be recommended in the
management of this problem. However, studies evaluating the efficacy of these pharmacological
agents were found to be insufficient in terms of evidence.
Non-pharmacological approaches whose effectiveness has been evaluated in the management of
chemotherapy-related peripheral neuropathy are acupuncture, acupressure, neurofeedback,
scrambler therapy, cold application, reflexology, massage, exercise, relaxation techniques,
physical therapy, and magnetic therapy.
Exercise, one of these approaches, has been reported to be effective in reducing pain,
numbness, tingling, loss of sensation, and increasing muscle strength and balance due to
peripheral neuropathy in different patient groups. In a quasi-experimental study conducted on
patients with a modified neuropathy score (range 0-20) of 5 and above, it was observed that
closed kinetic exercises decreased the neuropathy score and increased the balance. A 10-week
home-based exercise program for breast cancer patients has been shown to improve symptoms of
peripheral neuropathy. In a randomized controlled study with patients with metastatic
colorectal cancer, resistance and balance exercises were applied to the experimental group
for eight weeks. According to the results of the study, when the experimental group and the
control group were compared, peripheral neuropathy symptoms remained the same, while a
significant improvement was found in balance functions. In the study of Bland et al., it was
stated that exercise significantly improved the CIPN20 score and reduced peripheral
neuropathy in patients with breast cancer receiving taxane therapy. However, although the
number of studies showing exercise efficacy in managing chemotherapy-associated peripheral
neuropathy is quite limited, studies with small samples have low evidence strength.
This study was planned to determine whether exercise is an effective approach in the
management of chemotherapy-associated peripheral neuropathy in oncology patients.
