Breast Neoplasms, Ovarian Neoplasms, Paresthesia
Conditions
Brief summary
The objective of this trial is to study the management of PPE in participants with metastatic ovarian or breast cancer treated with Caelyx, and determine the frequency of use of pharmacological treatment (preventive or therapeutic) for PPE and compliance of educational recommendations for PPE.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women 18 years of age or older. * Participants with metastatic breast or ovarian cancer who are receiving treatment with pegylated liposomal doxorubicin. * Participants who have given their written consent.
Exclusion criteria
* Participants who are currently participating in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Participants will do a single visit, but cases will be collected during a period of 12 months. | Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE. Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it. |
| Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE | Participants will do a single visit, but cases will be collected during a period of 12 months. | The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caelyx Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment. | 154 |
| Total | 154 |
Baseline characteristics
| Characteristic | Caelyx |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment Canada | 154 participants |
| Sex: Female, Male Female | 154 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 122 / 154 |
| serious Total, serious adverse events | 3 / 154 |
Outcome results
Primary
Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE
The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.
Time frame: Participants will do a single visit, but cases will be collected during a period of 12 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caelyx | Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE | Curative Treatment | 14 Participants |
| Caelyx | Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE | Prophylaxis | 52 Participants |
| Caelyx | Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE | Curative & Prophylactic Treatment | 6 Participants |
Primary
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE. Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it.
Time frame: Participants will do a single visit, but cases will be collected during a period of 12 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Avoid Sweating and Physical Activity | 14 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Avoid Tight-Fitting Clothing | 14 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Local Cooling of Hands and Feet | 13 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Oral Dexamethosone | 10 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Pyridoxine | 8 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Topical Corticosteroids | 8 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Topical Dimethyl Sulfoxide | 3 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Intravenous Dexamethasone | 1 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Prostaglandins | 1 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Avoid Excessive Heat/Water | 14 Participants |
| Caelyx | Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) | Keep Skin Hydrated | 14 Participants |