An observational study in Ovarian Neoplasms, Breast Neoplasms and Paresthesia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-27.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Observational
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.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's enrollment of 154 is below the median of 200 across 616 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with metastatic ovarian or breast cancer, to be recruited from the Oncology Departments of 16 centers for a period of 12 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications.
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.
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.
| Milestone | Caelyx |
|---|---|
| Started | 154 |
| Completed | 154 |
| Not completed | 0 |
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.
| Participants | Caelyx |
|---|---|
| Oral Dexamethosone | 10 |
| Pyridoxine | 8 |
| Topical Corticosteroids | 8 |
| Topical Dimethyl Sulfoxide | 3 |
| Intravenous Dexamethasone | 1 |
| Prostaglandins | 1 |
| Avoid Excessive Heat/Water | 14 |
| Keep Skin Hydrated | 14 |
| Avoid Sweating and Physical Activity | 14 |
| Avoid Tight-Fitting Clothing | 14 |
| Local Cooling of Hands and Feet | 13 |
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.
| Participants | Caelyx |
|---|---|
| Curative Treatment | 14 |
| Prophylaxis | 52 |
| Curative & Prophylactic Treatment | 6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Caelyx | — | 3/154 (1.9%) | 122/154 (79.2%) |
| Event | Caelyx |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 2/154 |
| AnaemiaBlood and lymphatic system disorders | 1/154 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/154 |
| Event | Caelyx |
|---|---|
| StomatitisGastrointestinal disorders | 68/154 |
| AstheniaGeneral disorders | 61/154 |
| NauseaGastrointestinal disorders | 51/154 |
| AlopeciaSkin and subcutaneous tissue disorders | 44/154 |
| AnorexiaMetabolism and nutrition disorders | 27/154 |
| ConstipationGastrointestinal disorders | 21/154 |
| DiarrhoeaGastrointestinal disorders | 21/154 |
| NeutropeniaBlood and lymphatic system disorders | 18/154 |
| VomitingGastrointestinal disorders | 15/154 |
| Abdominal painGastrointestinal disorders | 11/154 |
| Age, Continuous(years) | Caelyx |
|---|---|
| Mean | 62.4 ± 10.1 |
| Sex: Female, Male(Participants) | Caelyx |
|---|---|
| Female | 154 |
| Male | 0 |
| Region of Enrollment(participants) | Caelyx |
|---|---|
| Canada | 154 |
No study locations are listed for this record.
The record gives a start of Oct 2007, a primary completion of Jun 2009 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2011, 1 year 7 months after primary completion.
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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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