Randomized controlled study in patients with gastrointestinal tumors on the effects of acupuncture therapy and vibration training against chemotherapy-induced polyneuropathy (CIPN) under oxaliplatin-containing chemotherapy

Not Applicable

Recruiting

Conditions: G62.0
Drug-induced polyneuropathy

Registration Number: DRKS00022970

Lead Sponsor: Hamburger Krebsgesellschaft e.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 81

Inclusion Criteria

Chemotherapy with a treatment regimen containing oxaliplatin of at least 3 months duration (cumulative dose of oxaliplatin> 500 mg / m2) regardless of the intention (adjuvant or palliative)
Minimum age 18 years

Exclusion Criteria

Polyneuropathy of other origins (diabetes mellitus, alcohol abuse, paraneoplastic, consequences of previous chemotherapy, hereditary, chronic inflammatory, idiopathic etc.)
Illnesses jeopardize patient safety or the feasibility of the study, e.g. Coagulopathy or use of anticoagulants with a bleeding time> 3 min, prothrombin time <40%, platelets <50,000 / µl or PTT> 50 sec
Bacterial infection on the upper or lower extremities near the site of the planned acupuncture therapy
Bone fracture of the upper or lower extremities in the past 3 months
Osteolysis o osteosynthesis, knee or hip replacement
Acute thrombosis
Alcohol addiction
Or other diseases that the investigator believes jeopardize the safety of the patient or the feasibility of the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delta of the amplitude of the sensory nerve action potential of the sural nerve after 4 months

Secondary Outcome Measures

Name	Time	Method
Sensitive nerve conduction velocity of the sural nerve (N.Suralis SNLG)<br>Clinical neurological parameters: Sensitive qualities, temperature, pallesthesia, 2-point discrimination, gait tests, pain.<br>Neuropathy Deficit Score (NDS) (Dyck 1992)<br>Neuropathy Symptom Score (NSS) (Dyck 1992) Numerical Rating Scale (NRS) (Farrar 2001)<br>Depth sensitivity (tuning fork test)<br>Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)<br>Coordinative performance (Center of PressureMessung, Short Physical Performance Battery SPPB)<br>Strength ability (strength test, isometric using a hand strength dynamometer). Parameters are taken on inclusion examination, after 4 month and after 12 month