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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00022970
Enrollment
81
Registered
2020-09-03
Start date
2020-09-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G62.0

Interventions

Group 1: Needle acupuncture 1x / week of 20 minutes for 16 weeks Group 2: Vibration training twice a week for 16 weeks Group 3: Needle acupuncture waiting list

Sponsors

Hamburger Krebsgesellschaft e.V.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactSven Schröder

TCM am UKE

schroeder@tcm-am-uke.de040 42916350

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026