Cryocompression pour réduire la neuropathie périphérique induite par la chimiothérapie dans le cancer gynécologique - COHORTE 2
Utilisation de la cryocompression pour réduire la neuropathie périphérique induite par la chimiothérapie dans le cancer gynécologique : un essai contrôlé randomisé - 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Amelia Scott
- Numéro de téléphone: 919-613-4584
- E-mail: amelia.lorenzo@duke.edu
Lieux d'étude
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Connecticut
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Hartford, Connecticut, États-Unis, 06106
- Recrutement
- Hartford Healthcare Cancer Institute
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Chercheur principal:
- Amy Brown, MD
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Contact:
- Siobhan Reilly
- Numéro de téléphone: 860-696-4958
- E-mail: Siobhan.Reilly@hhchealth.org
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Middletown, Connecticut, États-Unis, 06457
- Recrutement
- Middlesex Health Cancer Center - Middletown
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Chercheur principal:
- Karthikeyan Kandevelou, MD
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Contact:
- Loriann MacLean, MSN
- Numéro de téléphone: (860)358-2015
- E-mail: loriann.maclean@midhosp.org
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Recrutement
- Duke University Medical Center
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Chercheur principal:
- Laura Havrilesky, MD
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Contact:
- Amelia Scott
- Numéro de téléphone: (919) 613-4584
- E-mail: amelia.lorenzo@duke.edu
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Virginia
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Roanoke, Virginia, États-Unis, 24016
- Recrutement
- Carilion Clinic
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Chercheur principal:
- Erin Saks, MD
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Contact:
- Anna Derrick
- Numéro de téléphone: 540-581-0160
- E-mail: acderrick@carilionclinic.org
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Cryothérapie
|
Participants will receive cryotherapy on both hands and feet |
|
Expérimental: Compression avec cryothérapie
|
Participants will receive cryotherapy on both hands and feet Participants will receive compression on both hands and feet |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tolerability of cryocompression: scale
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Laura Havrilesky, DUHS
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00106236_1
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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