Trial document




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  DRKS00022970

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Peripheral nervous system disorders are common and often result in permanent physical disabilities. The most common disease of the peripheral nervous system is polyneuropathy. A typical manifestation is a distally symmetrical expression on the lower extremities in a limb-like ascending manner (hypesthesia, hypalgesia, hyperpathia, allodynia, paresthesia and paresis). Patients are often severely impaired by painful abnormal sensations that may require long-term, intensified pain therapy. Polyneuropathy often arises as part of chemotherapy as a side effect of therapy. This side effect occurs among others with vinca alkaloids, platinum derivatives, taxanes and also the newer substances such as bortezomib and thalidomide. Symptoms of CIPN can vary; motor, sensory, and autonomic nerves can be affected. In the foreground, however, are usually the sensitive symptoms, such as numbness, tingling sensations as well as shooting and burning pains, in a typical sock or glove-shaped form, ascending from distal to proximal. Therapies are important given the large number of people affected.

Because of the lack of established therapeutic options for the treatment and prophylaxis of diseases of the peripheral nervous system in western medicine, there is a great need to develop new therapeutic options. In Traditional Chinese Medicine (TCM) strategies have been developed over centuries for these problems, which today have to be adapted to the requirements of modern evidence-based medicine. Here acupuncture offers very interesting possibilities, which have not yet been used on a larger scale in western countries. Acupuncture is an applied and common method in pain therapy for acute and chronic pain conditions. The acupuncture treatment of polyneuropathy (PNP) has only recently been introduced as a therapy option in the West, although the WHO included the disease in the list of those diseases for which acupuncture is considered useful as early as 1979.

Acupuncture has been investigated in several pilot studies for the treatment of polyneuropathies of various diseases, HIV, diabetes and PNP of unknown cause, with mostly positive results for acupuncture. Different case series and pilot studies were able to confirm these effects for the CIPN.

Vibration training has a variety of physiological and physical influences. Vibration therapy was introduced a few years ago as an innovative method for treating polyneuropathy. After positive pilot studies in patients with diabetic PNP, these results were confirmed in two randomized studies in patients.

The transferability of these data to the CIPN must be investigated in further studies. Due to the positive effects of vibration training on other different forms of PNP, an improvement in the symptoms of CIPN can also be expected.

In order to assess the effect of acupuncture and vibration training, studies are required whose changes can be measured objectively. The examination of acupuncture in polyneuropathy, which can be quantified by means of electroneurography (ENG), is suitable here.

The presented work aims to contribute to the question of the effectiveness of acupuncture and vibration training by examining whether subjective therapeutic effects can withstand the objective measurement using ENG.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00022970
  •   2020/09/03
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  •   yes
  •   Approved
  •   PV5987, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   G62.0 -  Drug-induced polyneuropathy
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Interventions/Observational Groups

  •   Needle acupuncture 1x / week of 20 minutes for 16 weeks
  •   Vibration training twice a week for 16 weeks
  •   Needle acupuncture waiting list
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2020/09/04
  •   81
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Hamburger Krebsgesellschaft e.V.
    • Ms.  Franziska  Holt 
    • Butenfeld 18
    • 22529  Hamburg
    • Germany
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    • UKE für das Studiennetzwerk gastrointestinale Tumoren
    • Mr.  PD Dr. med.  Alexander  Stein 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • TCM am UKE
    • Mr.  PD Dr. med.  Sven Schröder  Schröder 
    • Martinistr. 52
    • 20251  Hamburg
    • Germany
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    • TCM am UKE
    • Mr.  PD Dr. med.  Sven  Schröder 
    • Martinistr. 52
    • 20251  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Hamburger Krebsgesellschaft e.V.
    • Butenfeld 18
    • 22529  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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