Clinical Trial: Study of TENS in Reducing Symptoms of Peripheral Neuropathy Induced by Chemotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Use of Transcutaneous Electrical Nerve Stimulation (Tens) in Reducing Symptoms of Peripheral Neuropathy Induced by Antineoplastic Chemotherapy

Brief Summary: This study aims to investigate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) in reducing the symptoms of pain and numbness and improve the daily lives of cancer patients who have Chemotherapy-induced peripheral neuropathy (CIPN).

Detailed Summary:

Chemotherapy-induced peripheral neuropathy (CIPN) results from damage or dysfunction of the peripheral nerves and is one of the most common side effects of antineoplastic chemotherapy when neurotoxic drugs are used. Pain and paresthesia symptoms are prevalent, causing chronic discomfort and loss of functional abilities whilst also interfering negatively with quality of life and the patient's autonomy. In a pilot study of patients with CIPN, there was evidence that Transcutaneous Electrical Nerve Stimulation (TENS) improved the painful symptoms of patients with CIPN. This study aims to investigate the effects of TENS in reducing the symptoms of pain and numbness and improve the daily lives of cancer patients who have CIPN.

1. Primary Objectives Evaluate the effects of TENS in the reduction of symptoms related to peripheral neuropathy due to chemotherapy treatment of a high and moderate neurotoxic potential in cancer patients.

Secondary Objectives:

  • Evaluate the therapeutic response of TENS with frequency variation (FV) in symptoms of paresthesia
  • Evaluate the therapeutic response of TENS with frequency variation (FV) in activities of the daily lives of patients
  • Evaluate the therapeutic response of TENS with frequency variation (FV) in symptoms of neuropathic pain.
  • Evaluate the factors associated with better treatment response in paresthesia, in pain and activities of daily living.

Eligibility criteria: The participants of the research will include patients with any cancer diagnosis who are being subjected to chemotherapy in either adjuvant or neoadjuvant therapy, containing in its proto
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: Evaluate the effects of TENS in the reduction of symptoms related to peripheral neuropathy due to chemotherapy treatment of a high and moderate neurotoxic potential in cancer patients. [ Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks). ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluate the therapeutic response of TENS in symptoms of paresthesia [ Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks). ]
  • Evaluate the therapeutic response of TENS in activities of the daily lives of patients. [ Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks). ]
  • Evaluate the therapeutic response of TENS in symptoms of neuropathic pain. [ Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks). ]
  • Evaluate the factors associated with better treatment response in paresthesia, in pain and activities of daily living. [ Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks). ]


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: April 1, 2014
Date Started: June 2014
Date Completion: December 2017
Last Updated: February 12, 2016
Last Verified: February 2016