Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2

Официальное название

Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Cryotherapy
  Participants will receive cryotherapy on both hands and feet
• Поведенческое Compression
  Participants will receive compression on both hands and feet

Первичные конечные точки

• Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time [Срок оценки: Up to two months after completion of chemotherapy, an average of 6 months]

Вторичные конечные точки (5)

• Tolerability of cryocompression: scale [Срок оценки: Up to two months after completion of chemotherapy, an average of 6 months]
• Acceptability: scale [Срок оценки: 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 [Срок оценки: Up to two months after completion of chemotherapy, an average of 6 months]
• Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time [Срок оценки: Up to two months after completion of chemotherapy, an average of 6 months]
• Chemotherapy Dose [Срок оценки: Up to two months after completion of chemotherapy, an average of 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 4 центра

• Hartford Healthcare Cancer Institute — Hartford
• Middlesex Health Cancer Center - Middletown — Middletown
• Duke University Medical Center — Durham
• Carilion Clinic — Roanoke

Идентификаторы

NCT: NCT06139458 · Pro00106236_1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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