Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cryotherapy
BehavioralParticipants will receive cryotherapy on both hands and feet
Compression
BehavioralParticipants will receive compression on both hands and feet
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: CryotherapyExperimental treatment 1 intervention
Group B: Compression with CryotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
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.
Time frame
Up to two months after completion of chemotherapy, an average of 6 monthsSecondary outcomes
1
Tolerability of cryocompression: scale
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.
Time frame
Up to two months after completion of chemotherapy, an average of 6 months2
Acceptability: scale
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".
Time frame
Up to two months after completion of chemotherapy, an average of 6 months3
Measure of manageability and acceptability for staff involved in the participants' care
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."
Time frame
Up to two months after completion of chemotherapy, an average of 6 months4
Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
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).
Time frame
Up to two months after completion of chemotherapy, an average of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov