Kriokompresja w celu zmniejszenia neuropatii obwodowej wywołanej chemioterapią w raku ginekologicznym – COHORT 2
Zastosowanie kriokompresji w celu zmniejszenia neuropatii obwodowej wywołanej chemioterapią w raku ginekologicznym: randomizowane badanie kontrolowane – COHORT 2
The investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. The investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Participants will be randomized by patient to receive cryotherapy wraps plus compression therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands and feet. Participants will receive cryotherapy (+/- compression) for the duration of their taxane infusions. Participants will be asked to complete the FACT-NTX survey and a PNQ neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy. Participants will also complete a brief acceptability and tolerability survey at each visit. Lastly, a staff satisfaction survey will be administered at each visit as well. The investigators will test the hypothesis that the average final visit FACT-NTX11 scores in the cryotherapy group are noninferior to the cryocompression group with a noninferiority margin of 2.5 points. The investigators will routinely monitor for the following adverse events: frost bite, (unexpected) hospitalizations, and death.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Amelia Scott
- Numer telefonu: 919-613-4584
- E-mail: amelia.lorenzo@duke.edu
Lokalizacje studiów
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-
Connecticut
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Hartford, Connecticut, Stany Zjednoczone, 06106
- Rekrutacyjny
- Hartford Healthcare Cancer Institute
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Główny śledczy:
- Amy Brown, MD
-
Kontakt:
- Siobhan Reilly
- Numer telefonu: 860-696-4958
- E-mail: Siobhan.Reilly@hhchealth.org
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Middletown, Connecticut, Stany Zjednoczone, 06457
- Rekrutacyjny
- Middlesex Health Cancer Center - Middletown
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Główny śledczy:
- Karthikeyan Kandevelou, MD
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Kontakt:
- Loriann MacLean, MSN
- Numer telefonu: (860)358-2015
- E-mail: loriann.maclean@midhosp.org
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27710
- Rekrutacyjny
- Duke University Medical Center
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Główny śledczy:
- Laura Havrilesky, MD
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Kontakt:
- Amelia Scott
- Numer telefonu: (919) 613-4584
- E-mail: amelia.lorenzo@duke.edu
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Virginia
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Roanoke, Virginia, Stany Zjednoczone, 24016
- Rekrutacyjny
- Carilion Clinic
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Główny śledczy:
- Erin Saks, MD
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Kontakt:
- Anna Derrick
- Numer telefonu: 540-581-0160
- E-mail: acderrick@carilionclinic.org
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible)
- Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at the Duke Cancer Center or Macon Pond or at the Carilion Clinic in Roanoke, VA. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
Exclusion Criteria:
- Treated with prior neurotoxic chemotherapeutic agents
- Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Krioterapia
|
Participants will receive cryotherapy on both hands and feet |
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Eksperymentalny: Kompresja z krioterapią
|
Participants will receive cryotherapy on both hands and feet Participants will receive compression on both hands and feet |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
Ramy czasowe: Up to two months after completion of chemotherapy, an average of 6 months
|
The FACT-NTX is a patient self-reported 11-item questionnaire used for evaluating symptoms and concerns specifically associated with chemotherapy induced neuropathy. The total score ranges from 0-44, and a lower FACT-NTX score corresponds to worsening neuropathy. For both the FACT-NTX and the sensory subscale of the FACT-NTX, a significant decrease in the score is defined as a decrease exceeding 10% from baseline. |
Up to two months after completion of chemotherapy, an average of 6 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Tolerability of cryocompression: scale
Ramy czasowe: Up to two months after completion of chemotherapy, an average of 6 months
|
Subjects will be asked to complete a cryocompression tolerability assessment after each chemotherapy session in which they will answer the question, "How tolerable was the cryocompression procedure for you?" on a scale from 0 to 100. A score of 0 means "not tolerable at all" and a score of 100 is "very tolerable". Pain, abnormal sensation, and adherence to cryocompression will also be evaluated as patient-reported measures of tolerability. |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Acceptability: scale
Ramy czasowe: Up to two months after completion of chemotherapy, an average of 6 months
|
Subjects will be asked to complete a cryocompression acceptability assessment after each chemotherapy session in which they answer the questions, "How acceptable was the cryocompression procedure to you?" and "How likely are you to continue with cryocompression at your next chemotherapy treatment?" on a scale from 0 to 100, with 0 being "not acceptable, not likely to continue" and 100 being "very acceptable, very likely to continue". |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Measure of manageability and acceptability for staff involved in the participants' care
Ramy czasowe: Up to two months after completion of chemotherapy, an average of 6 months
|
Staff will be asked to complete an acceptability assessment after each chemotherapy session in which they will answer the question, "How manageable or acceptable was this patient's cryotherapy/cryocompression therapy to you in working with a patient receiving chemotherapy?" on a scale from 0 to 100. A score of 0 means "not at all acceptable" and a score of 100 is "complete acceptable". They will also be asked "In your experience, compare the ease of use of the cryotherapy wrap versus plastic ice bags" on a scale from 0 to 100. A score of 0 means "cryotherapy wraps are much harder," and a score of 100 means "cryotherapy wraps are much easier." |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
Ramy czasowe: Up to two months after completion of chemotherapy, an average of 6 months
|
PNQ is a patient-reported questionnaire that consists of 2 items, representing motor and sensory components, with increasing grades for worsening symptoms. Patients will respond to each question for each of their 4 extremities by grading sensory and motor symptoms as A (no neuropathy), B (mild neuropathy), C (moderate neuropathy that does not interfere with activities of daily living [ADL]), D (moderate neuropathy that does interfere with ADL), or E (severe neuropathy that interferes with ADL). |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Chemotherapy Dose
Ramy czasowe: Up to two months after completion of chemotherapy, an average of 6 months
|
Study staff will record the taxol dose at each cycle |
Up to two months after completion of chemotherapy, an average of 6 months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Laura Havrilesky, DUHS
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Pro00106236_1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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