Chemotherapy-induced Peripheral Neuropathy (CIPN) on Motor and Sensory Function
Condition: Cancer; Chemotherapy-induced Peripheral Neuropathy; Chemotherapeutic Toxicity; Breast Cancer; Breast Neoplasms; Colon Neoplasm; Colo-rectal Cancer
MeSH terms: Neoplasms; Breast Neoplasms; Colonic Neoplasms; Peripheral Nervous System Diseases
Study type: Observational

Summary: 
      As cancer survival rates have been increased due to technological developments and early
      detection strategies, there has been been a growing need to assess the effect of long-term
      complications and adverse effects upon patients' functionality and quality of life.
      Chemotherapy, which is accepted to be the body of systemic adjuvant therapy is attributed to
      long-term survival, yet some side effects such as sarcopenia, loss of muscle strength and
      functional capacity, fatigue, and sensory disturbances due to the neurotoxic effects have
      been well known. Chemotherapy-induced peripheral neuropathy (CIPN) is a condition that is
      characterized by main loss of cutaneous sensation especially in the distal part of the
      extremities. CIPN affects approximately 30-40% of patients with cancer undergoing
      chemotherapy. Loss of sensation in distal sides of upper and lower extremities may cause not
      only deterioration of fine hand skills but also loss of balance and thereby one's mobility
      and independence are detrimentally affected. Thus, this study is aimed to assess CIPN in
      patients with cancer undergoing chemotherapy in a longitudinal design by assessing the
      cutaneous function of the sensory nerves and related effect of motor function.
    

Detailed description: 
      Chemotherapy-induced peripheral neuropathy (CIPN) which affects over 30-40% of patients with
      cancer undergoing chemotherapy cause cutaneous loss of sensation. A specific and selective
      function carries great importance not only in daily life but also in task-specific complex
      movements. Since the long-term survival of cancer is increased, back to work is quite
      important in both one's participation in community life and financial issues. Irrespective of
      age or other socio-clinical and socio-demographic characteristics, patients may be affected
      detrimentally after systemic adjuvant chemotherapy implementation in the perspective of
      sensory and motor aspects. Thus, this study is aimed to assess cutaneous sensory and motor
      function in patients with cancer undergoing chemotherapy in a longitudinal design.

      Study Setting:

      This research was planned as an observational-cross sectional cohort study within a
      longitudinal design. Patients diagnosed with cancer and applied to medical oncology unit in
      Izmir Bakircay University Çiğli State and Training Hospital for systemic adjuvant
      chemotherapy will be assessed in three different time points set as following: Time 1: before
      chemotherapy application, Time 2: interim time point (approx.8 weeks later) and Time 3:
      post-chemotherapy time point (12-20 weeks later after initial assessment). The main outcome
      measures were set as handgrip strength and Minnesota Rate of Manipulation Test (MRMT) for
      motor function while Semmens-Weinstein Monofilament Test (SWMT) for sensory evaluation.
      Secondarily, patients' quality of life and fatigue will be assessed with European
      Organization of Research and Treatment of Cancer (EORTC) specific scales such as QLQ-C30 for
      general quality of life and QLQ-FA12 for fatigue.

      Hand Grip Strength:

      Hand-Grip Strength Handgrip strength will be assessed with Lafayette Professional Hand
      Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can
      be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned;
      90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to
      assess hang-grip strength. Three measurements will be requested and the maximum value of them
      will be recorded.

      MRMT:

      The Minnesota Rate of Manipulation test (MRMT, LaFayatte Instruments, NY, USA) will be used
      to assess the fine hand skills of patients who undergo chemotherapy. There are five other
      sub-tests to evaluate hand function such as one or two hands turning, displacing, etc.
      However, since CIPN might affect both hands, we chose to use two hands turning and placing
      the test.

      Briefly, 60 wooden circle-shaped discs are placed on the pegboard. (15 discs x 4 row).
      Patients are requested to stand in front of the pegboard. Each patient will be informed about
      the test as following: "Start with the top-right corner of the board. Hold the disc and turn
      with your right hand, give it to your left then place it again. Continue this until reaching
      the top left corner. In the second row, you will start to top left corner, hold the disc and
      turn with your left hand, give it to your right and place it again". Patients also will be
      informed about doing this as best and fast they can while avoiding exaggerated movements of
      the trunk. Each patient will be tested for two trials, the third one will be the main test in
      which time will be calculated via chronometer.

      Scales and Forms:

      There will be scales and form which are required to fill out by participants. The following
      list of scales will be filled with participants themselves.

      The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
      (EORTC-QLQ-C30) is the most frequently used cancer-specific health-related questionnaire. It
      consists of 28 items and each is scored "1: None" through "4: A lot" according to the 4-based
      Likert Scoring System. Besides, Item 29 and 30 are scored "1" through "7" in which are asked
      about health and quality of life through the last week. The higher scores indicate the worst
      quality of life or vice versa.

      EORTC-QLQ-BR23 is the sub-module of the C30 questionnaire which consists of a total of 23
      items. Scoring and interpretation of the questionnaire total score are the same as with the
      C30 questionnaire. Patients diagnosed with breast cancer and who volunteered to participate
      in this study are also requested to fill out this health-related quality of life
      patient-reported outcome scale. While C30 is requested to fill out for all patients.

      Functional Assessment of Cancer Therapy (FACT-B+) The Functional Assessment of Cancer
      Therapy- Breast (FACT-B) consists of 37 items. To assess the health-related specific quality
      of life of patients with breast cancer, each item is scored "0: None" through "4: A Lot".
      Emotional, Functional, Physical, Social, and Family and Other Concerns are the main
      sub-domains that directly assess the related quality of life. Higher scores indicate worst,
      while lower scores indicate the best.

      Purpose of This Research:

        1. To evaluate the effect of chemotherapy-induced peripheral neuropathy (CIPN) on the motor
           and sensory function

        2. To compare results of functional capacity, motor and sensory function between
           pre-chemotherapy and post-chemotherapy

      The hypothesis of this study:

      H0: There is no difference in hand and plantar cutaneous sensory function between
      pre-chemotherapy and post-chemotherapy periods H1-1: Cutaneous function of both sides of the
      hand and plantar skin tissue is decreased due to chemotherapy.

      H2-1: Functional capacity and quality of life are decreased due to chemotherapy compared to
      the baseline values.

      H3-1: Handgrip strength and Hand dexterity test results are worsened due to chemotherapy
      compared to the baseline values.

      Power Analysis:

      A priori power analysis was performed via the G*Power 3.1.9 program. Since there will be
      repeated measures along with three different time points, a power analysis was performed
      according to the within-group factors design in repeated measures analysis of variance test.
      Middle effect size according to the partial eta squared was set at 0.03 then general effect
      size was calculated as 0.17. In 95% Confidence Interval and 80% power, setting non-sphericity
      correction as default and correlation among repeated measures was set as 0.5. It was found
      that a total of 54 participants are needed to achieve these results, however, in case of a
      10% potential drop-out rate and possible violation of sphericity, it is planned to include a
      total of 72 patients in this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with cancer especially with colon, colorectal, and breast who will
        undergo a systemic adjuvant chemotherapy implementation.
      
Keywords: Chemotherapy-induced Peripheral Neuropathy; Hand Grip; Cutaneous; Quality of Life