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Oxaliplatin

A multi frequency tactilometry device to evaluate the vibrotactile sense to indicate the underlying (Oxaliplatin induced poly neuropathy) OIPN and then compare the results with the results of CTCAE (Common toxicity criteria of adverse events) assessment tool evaluation.

VibrosSense Meter®

Oxaliplatin is a cytotoxic platinum compound and is one of the chemotherapeutic agent used in advanced colorectal cancer. It is used combined with Fluorouracil (5 FU) and Leucovorin. The main and most suffering side effect of oxaliplatin is polyneuropathy. Oxaliplatin-induced polyneuropathy (OIPN) can be acute and/or chronic neurotoxicity.

The early detection of the neurotoxicity and changing the medication dose and/or schedule can prevent its development. It has been used different neurotoxicity scales in grading OIPN. In this study the investigators try to investigate whether the evaluation of the vibrotactile perception VTP, by using a multi frequency tactilometry in a patients hand and foot is a good indicator and superior to the standard of care to detect the underlying OIPN in patients undergoing adjuvant chemotherapy treatment with FOLFOX, FLOX or XELOX regime.

Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime

Multi frequency tactilometry device is used.

Lund University Hospital

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Substance Related Disorders

Breast Neoplasms

Cognition Disorders

Chemotherapy-Related Cognitive Impairment

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

patients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination chemotherapy

patients with benign gynecological tumors after laparoscopic surgical resection

patients with breast cancer with anti-hormonal and/or localized radiation treatment but no chemotherapy

standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines

Chemotherapy

Petra Huehnchen, Dr.

Neurotoxic phenomena are among the most common and difficult to treat side effects of chemotherapy. The development of chemotherapy induced peripheral neuropathy (CIPN) is a well-recognized adverse reaction in the peripheral nervous system. Side effects of chemotherapy in the central nervous system, however, particularly changes of cognitive function (in non-medical literature referred to as "chemobrain") are diffuse and difficult to attribute to individual cytostatic drugs. The primary purpose of this study is to assess cognitive function in patients with ovarian and breast cancer before and after systemic chemotherapy with paclitaxel with standardized neuropsychological tests and compare the outcome to patients with benign gynecological tumors and breast cancer without chemotherapy treatment, respectively. Secondary parameters include the assessment of olfactory function, total neuropathy score and cytokine profiles.

Primary outcome parameter:

compound score of standardized neuropsychological test

Secondary parameters:

* olfactory function (Sniffin Sticks)
* total neuropathy score (TNS), reduced version (clinical examination, neurography of sural and peroneal nerve)
* cytokine profiling from serum samples (ELISA)
* quality of life (questionnaire)
* depression screening (questionnaire)
* symptoms of polyneuropathy (questionnaire)
* symptoms of cognitive impairment (everyday memory test questionnaire)

Assessment time points:

* baseline (after surgical tumor resection and before chemotherapy)
* follow up 1 (3 weeks after last chemotherapy cycle or 21 weeks (control patients))
* follow up 2 (optional; 1 year after chemotherapy completion)

Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer

Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)

standardized neuropsychological test covering verbal memory, visual-spatial memory, short term/ working memory, executive functions

standardized test battery (Sniffin Sticks)

reduced version includes clinical examination and neurography of sural and peroneal nerve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime	NCT03542136	Colorectal Canc...	VibrosSense Met...	18 Years -	Lund University Hospital
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer	NCT02753036	Cognition Disor... Polyneuropathie...	Chemotherapy	18 Years - 70 Years	Charite University, Berlin, Germany
Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime	NCT03542136	Colorectal Canc...	VibrosSense Met...	18 Years -	Lund University Hospital
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer	NCT02753036	Cognition Disor... Polyneuropathie...	Chemotherapy	18 Years - 70 Years	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for polyneuropathy