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| Name | Class |
|---|---|
| Jessa Hospital | OTHER |
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ne of the most common cancers in women worldwide is breast cancer. A common used therapy in early-stage and metastatic breast cancer involves chemotherapy. Taxanes, microtubule-targeting agents (MTAs), are one of the most used chemotherapeutic agents in breast cancer patients. Unfortunately, this treatment comes with many unfortunate side effects. Chemotherapy-induced peripheral neuropathy (CIPN) is one of these common side effects. This condition involves paresthesia, numbness and/or burning pain in distal limbs. Eventually, loss of temperature sensation, loss of tendon reflexes and pain sensation can occur. Yet, no therapies have been developed to treat CIPN. At the moment, only symptom management is possible. Not only will this condition affect the patients' daily activities, but a chemotherapy dose reduction could also be necessary, influencing the outcome and overall survival rate of the patient.
A new and emerging treatment for CIPN is photobiomodulation therapy (PBMT) or low-level laser therapy. During PBMT, visible and/or (near)-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves. Studies have shown positive results for patients with diabetic neuropathy. However, no studies have been undertaken specifically for taxane-induced neuropathy (TIN).
We hypothesize that PBMT is an effective treatment strategy to prevent sensory symptoms associated with TIN. This can lead to an improved quality of life for the patient and no need for a chemotherapy dose reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| photobiomodulation therapy (PBMT) | Experimental | During photobiomodulation therapy (PBMT) or low-level laser therapy, visible and/or (near)-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves |
|
| Placebo group | Placebo Comparator | No PBMT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photobiomodulation therapy (PBMT) | Other | Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy) • The PBMT-group will receive twice-weekly laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy) |
| Measure | Description | Time Frame |
|---|---|---|
| The modified total neuropathy score (mTNS) | he mTNS is a composite scale that includes patient report of sensory and motor symptoms, pin sensibility, quantitative vibration thresholds, strength using manual muscle tests, and deep tendon reflexes. The higher the score, the more severe the peripheral neuropathy. The mTNS is a clinically applicable, sensitive screening tool for CIPN. | baseline |
| The modified total neuropathy score (mTNS) | he mTNS is a composite scale that includes patient report of sensory and motor symptoms, pin sensibility, quantitative vibration thresholds, strength using manual muscle tests, and deep tendon reflexes. The higher the score, the more severe the peripheral neuropathy. The mTNS is a clinically applicable, sensitive screening tool for CIPN. | week 6 |
| The modified total neuropathy score (mTNS) | he mTNS is a composite scale that includes patient report of sensory and motor symptoms, pin sensibility, quantitative vibration thresholds, strength using manual muscle tests, and deep tendon reflexes. The higher the score, the more severe the peripheral neuropathy. The mTNS is a clinically applicable, sensitive screening tool for CIPN. | week 12 |
| The modified total neuropathy score (mTNS) | he mTNS is a composite scale that includes patient report of sensory and motor symptoms, pin sensibility, quantitative vibration thresholds, strength using manual muscle tests, and deep tendon reflexes. The higher the score, the more severe the peripheral neuropathy. The mTNS is a clinically applicable, sensitive screening tool for CIPN. | week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane) | The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane) is a patient questionnaire to test the quality of life of the patients with taxane induced neuropathy (TIN) and can be divided into five components: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific for taxane treated patients. The higher the score, the better the quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jeroen Mebis, prof. dr. | Jessa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35312857 | Derived | Joy L, Jolien R, Marithe C, Stijn E, Laura S, Hilde L, Sandra B, Wendy N, Ruth H, Liesbeth R, Sylvana S, Sylvia H, Jeroen M. The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial). Support Care Cancer. 2022 Jun;30(6):5509-5517. doi: 10.1007/s00520-022-06975-x. Epub 2022 Mar 21. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| sham laser sessions | Other | • The control group will undergo twice-weekly sham laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy). The laser device will be placed on the same manner and for the same period of time on the identified body sites, but the device will not be switched on. |
|
| baseline |
| Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane) | The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane) is a patient questionnaire to test the quality of life of the patients with taxane induced neuropathy (TIN) and can be divided into five components: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific for taxane treated patients. The higher the score, the better the quality of life. | week 6 |
| Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane) | The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane) is a patient questionnaire to test the quality of life of the patients with taxane induced neuropathy (TIN) and can be divided into five components: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific for taxane treated patients. The higher the score, the better the quality of life. | week 12 |
| Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane) | The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane) is a patient questionnaire to test the quality of life of the patients with taxane induced neuropathy (TIN) and can be divided into five components: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific for taxane treated patients. The higher the score, the better the quality of life. | week 15 |
| Pain evaluation | mechanical visual analogue scale (VAS) will be used to evaluate the patients' pain level due to TIN. | baseline |
| Pain evaluation | mechanical visual analogue scale (VAS) will be used to evaluate the patients' pain level due to TIN. | week 6 |
| Pain evaluation | mechanical visual analogue scale (VAS) will be used to evaluate the patients' pain level due to TIN. | week 12 |
| Pain evaluation | mechanical visual analogue scale (VAS) will be used to evaluate the patients' pain level due to TIN. | week 15 |
| D017437 |
| Skin and Connective Tissue Diseases |