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.

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.

Taxane

Drug-related Side Effects and Adverse Reactions

Pain

Breast Cancer

Pregabalin

Placebo

Assaf HaRofeh Medical Center

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

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.

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

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.

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.

Assaf-Harofeh Medical Center

CANTAB test
Fill up questionnaires (HADS, PDQ, EORTC QLQ-C30, FACT-ES)
Optional blood draw (10mls; 2 teaspoons)
PET/MRI imaging scan (for 10 patients)

Nationa University Hospital

A Prospective Pilot Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive and Brain Function of Breast Cancer Patients

We hope to gain a better understanding of the complex and currently poorly understood relationship between chemotherapy/anti-hormonal therapy and possible cognitive decline in patients undergoing such therapy. In current practice, a large number of patients with primary breast cancer are offered adjuvant chemotherapy after surgery, followed by hormonal therapy in patients whose tumours are hormone receptor-positive. The management of many adverse effects of chemotherapy, such as nausea, vomiting and febrile neutropenia has improved, and concern has shifted to more subtle and potentially chronic problems such as cognitive dysfunction, which may affect patients' quality of life.

Haematology-Oncology

Tan Sing Huang

National University Hospital, Singapore

Chemotherapy regimen (XP):
D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr repeat every 3 weeks

XT Regimen:
D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1, D8 Genexol (Paclitaxel) 80 mg/m2 + D5W 500mL MIV over 3hrs Repeat every 3 weeks

First Line Chemotherapy

Capecitabine Plus Cisplatin Versus Capecitabine Plus Paclitaxel

Advanced or Recurrent Esophageal Squamous Cell Carcinoma

3.2 Overview of Study Design This study is a prospective, randomized, phase II study comparing response rate between patients with XP chemotherapy versus XG chemotherapy for patients with metastatic squamous cell carcinoma.
Chemotherapy regimen (XP):
D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr every 3 weeks
Chemotherapy regimen (XT):
D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1, D8 Genexol (Paclitaxel) 80 mg/m2 + D5W 500mL MIV over 3hrs every 3 weeks

Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT)

Samsung Medical Center

Efficacy Comparison Study of Combination Regimens to Treat Advanced Esophageal Squamous Cell Carcinoma

A Randomized Phase II Trial of Capecitabine Plus Cisplatin (XP) Versus Capecitabine Plus Paclitaxel (XT) as a First-line Treatment for Advanced or Recurrent Esophageal Squamous Cell Carcinoma

Young-Hyuck Im

professor

Ovarian Neoplasm

Doxil at 50mg/m2 infused over one hour every 3 or 4 weeks for 3-6 cycles

taxol/fatigue

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

A Prospective Pilot Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive and Brain Function of Breast Cancer Patients

Efficacy Comparison Study of Combination Regimens to Treat Advanced Esophageal Squamous Cell Carcinoma

DOXIL for Consolidation Therapy in Ovarian Cancer.

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