Cryocompressie om door chemotherapie geïnduceerde perifere neuropathie bij gynaecologische kanker te verminderen - COHORT 2
Gebruik van cryocompressie om door chemotherapie geïnduceerde perifere neuropathie bij gynaecologische kanker te verminderen: een gerandomiseerde gecontroleerde studie - 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Amelia Scott
- Telefoonnummer: 919-613-4584
- E-mail: amelia.lorenzo@duke.edu
Studie Locaties
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Connecticut
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Hartford, Connecticut, Verenigde Staten, 06106
- Werving
- Hartford Healthcare Cancer Institute
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Hoofdonderzoeker:
- Amy Brown, MD
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Contact:
- Siobhan Reilly
- Telefoonnummer: 860-696-4958
- E-mail: Siobhan.Reilly@hhchealth.org
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Middletown, Connecticut, Verenigde Staten, 06457
- Werving
- Middlesex Health Cancer Center - Middletown
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Hoofdonderzoeker:
- Karthikeyan Kandevelou, MD
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Contact:
- Loriann MacLean, MSN
- Telefoonnummer: (860)358-2015
- E-mail: loriann.maclean@midhosp.org
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27710
- Werving
- Duke University Medical Center
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Hoofdonderzoeker:
- Laura Havrilesky, MD
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Contact:
- Amelia Scott
- Telefoonnummer: (919) 613-4584
- E-mail: amelia.lorenzo@duke.edu
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Virginia
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Roanoke, Virginia, Verenigde Staten, 24016
- Werving
- Carilion Clinic
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Hoofdonderzoeker:
- Erin Saks, MD
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Contact:
- Anna Derrick
- Telefoonnummer: 540-581-0160
- E-mail: acderrick@carilionclinic.org
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Cryotherapie
|
Participants will receive cryotherapy on both hands and feet |
|
Experimenteel: Compressie met cryotherapie
|
Participants will receive cryotherapy on both hands and feet Participants will receive compression on both hands and feet |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Tolerability of cryocompression: scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Laura Havrilesky, DUHS
Studie record data
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Pro00106236_1
Plan Individuele Deelnemersgegevens (IPD)
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