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Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia

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ClinicalTrials.gov Identifier: NCT02024568
Recruitment Status : Unknown
Verified December 2013 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Brief Summary:

Paclitaxel is chemotherapeutic agent used in many of the most common anti-cancer regimens. Its use is frequently associated with moderate to severe muscle and joint pain that may persist for several days after the treatment. This side effect, known as "Arthralgia-Myalgia Syndrome, has a significant impact on the quality of life and functional abilities of those receiving the treatment, and is not alleviated by many of the interventions attempted for that purpose.

Sporadic reports suggest that a drug called gabapentin may be effective in the management of this adverse effect. Observations from our practice indicate that pregabalin, which possesses similar biological activity to that of gabapentin, may also be useful in preventing and treating paclitaxel associated myalgia - arthralgia.

The current study represents an initial evaluation of the hypothesis that pregabalin may be beneficial in the management of the symptoms due to the "Arthralgia-Myalgia Syndrome". The investigation will be carried out in the format of a small scale, randomized, placebo controlled trial with patients receiving paclitaxel in the course of standard treatment for breast cancer.


Condition or disease Intervention/treatment Phase
Taxane Drug-related Side Effects and Adverse Reactions Pain Breast Cancer Drug: Pregabalin Drug: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia
Study Start Date : December 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pregabalin

Includes 19 out of 38 subjects reporting athralgia-myalgia in the wake of paclitaxel infusion in the course of breast cancer treatment.

Pregabalin started on the evening before receiving infusion of paclitaxel and 5 day thereafter. Initial dosing of 75mg twice daily (morning + evening). Option for dose increase with additional 75mg in case of inadequate pain control. A minimal interval of 2 hours is required between doses.

In case of poorly tolerated side effects a reduction to 50mg doses is available.

Access to additional analgesic interventions is open as required for patient wellbeing.

Drug: Pregabalin
See arm description
Other Name: Lyrica

Placebo Comparator: Placebo

Includes 19 out of 38 subjects reporting athralgia-myalgia in the wake of paclitaxel infusion in the course of breast cancer treatment.

Placebo externally identical to the pregabalin 75mg capsules will be started on the evening before receiving infusion of paclitaxel and 5 day thereafter. Initial dosing of 1 capsule twice daily (morning + evening). Option for dose increase with additional capsule in case of inadequate pain control. A minimal interval of 2 hours is required between doses.

In case of poorly tolerated side effects a reduction to capsules with the appearance of 50mg pregabalin capsules is available.

Access to additional analgesic interventions is open as required for patient wellbeing.

Drug: Placebo
See arm description




Primary Outcome Measures :
  1. Integrated Numeric Pain Scores and Rescue Analgesic Medication Requirement as calculated by the method proposed by Silverman et al (Silverman, O'Connor et al. 1993). [ Time Frame: 16 months from study initiation ]
    Modern pain research acknowledges the subjective and complex nature of pain that complicates its assessment. Furthermore, ethical imperatives place constraints on the comparative control to serve the in evaluation of a novel analgesic intervention (Silverman, O'Connor et al. 1993). One of the solutions to this issue, using normalized ordinal evaluations of pain and analgesic drug consumption around a central value in a manner that also accounts for changes in analgesic drug requirements (Silverman, O'Connor et al. 1993) will serve for direct assessment of the study hypothesis.


Secondary Outcome Measures :
  1. Numeric Pain Score (NPS) [ Time Frame: 8 days after receiving cycle of paclitaxel ]

    Numeric Pain score (NPS*) evaluation of Myalgia / Arthralgia related pain. The scores to be considered will be the maximum values recorded over the course of the 7 days starting on the day the taxane is administered.

    *Numerical Rating Scale: 0-1 No pain; 2-3 Mild pain; 4-5 Discomforting - moderate pain; 6-7 Distressing - severe pain; 8-9 Intense - very severe pain; 10 - Unbearable pain


  2. The additional number of hours spent in horizontal position (∆HHP**) [ Time Frame: 8 days after receiving cycle of paclitaxel ]

    The additional number of hours spent in horizontal position (∆HHP**) as when lying down in bed, on couch, etc., during waking time will serve as an additional endpoint. It will be derived by subtracting the number of hours spent in horizontal position prior to taxane treatment from the number of hours in that position during the day with the highest pain score in the course of the week following treatment. Daytime hours will be calculated as the time between getting up in the morning and going to bed in the evening on the day preceding the infusion of the taxane.

    HHP - the number of Hours in Horizontal Position. ∆HHP - the additional number of hours in horizontal position; Post Treatment HHP - Baseline HHP = ∆HHP.


  3. FACT-taxane score [ Time Frame: On day of recruitment to active phase + one week after 4th cycle of paclitaxel since recruitment to active phase. ]
    The FACT-Taxane scale is a psychometric tool specifically developed to assess the impact of taxane based treatment on the quality of life (Cella, Peterman et al. 2003). Both the severity of pain and associated impact on daily activities, as well as established side effects of the study drug may affect the score on this scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Screening Criteria:

  • Signature of consent form.
  • Legal competence for expression of consent.
  • Patients with confirmed diagnosis of cancer of breast, free of confounding pain before the administration of chemotherapy.
  • Recommendation for treatment with paclitaxel containing protocols, prior to initiation of chemotherapy.
  • Age over 18.

Inclusion criteria for treatment phase:

  • Fulfillment of screening criteria.
  • Experience of myalgia-arthralgia related pain of moderate or worse degree of severity after a course of paclitaxel containing chemotherapy.

Exclusion Criteria:

  • Ongoing treatment with pregabalin or gabapentin.
  • Known restricting adverse events related to treatment with pregabalin or gabapentin.
  • Renal failure with GFR less than 30ml/min.
  • Participation in clinical trial 3 weeks or less prior to screening.
  • Confounding myalgia and / or arthralgia unrelated to chemotherapy.
  • Medical condition compromising the likelihood of completing the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024568


Contacts
Contact: Jonathan Grunfeld, M.D. ++972-(0)57-7346453 grunfeldj@asaf.health.gov.il

Locations
Israel
Assaf HaRofeh Medical Center Not yet recruiting
Be'er Ya'akov (Zerifin), Israel, 7030000
Principal Investigator: Jonathan Grunfeld, M.D.         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Jonathan Grunfeld, M.D. Employee of Asaf Harofeh M.C.

Publications:

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02024568     History of Changes
Other Study ID Numbers: 105/13
WS1826148 ( Other Grant/Funding Number: Pfizer IIR )
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

Keywords provided by Assaf-Harofeh Medical Center:
Pregabalin
Arthralgia Myalgia Syndrome
Paclitaxel
Pain management
Breast cancer

Additional relevant MeSH terms:
Arthralgia
Myalgia
Drug-Related Side Effects and Adverse Reactions
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Pain
Neuromuscular Diseases
Chemically-Induced Disorders
Paclitaxel
Pregabalin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Anti-Anxiety Agents
Tranquilizing Agents