Gynecologic CancerNCT06139458
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2
A study testing Cryotherapy and Compression in people with Gynecologic Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Duke University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Cryotherapy and Compression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Jan 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Amelia Scott, (919) 613-4584, amelia.lorenzo@duke.edu
Laura Havrilesky, MD
- Recruiting
Hartford Healthcare Cancer Institute
Hartford, Connecticut, 06106
Siobhan Reilly, 860-696-4958, Siobhan.Reilly@hhchealth.org
Amy Brown, MD
- Recruiting
Middlesex Health Cancer Center - Middletown
Middletown, Connecticut, 06457
Loriann MacLean, MSN, (860)358-2015, loriann.maclean@midhosp.org
Karthikeyan Kandevelou, MD
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24016
Anna Derrick, 540-581-0160, acderrick@carilionclinic.org
Erin Saks, MD
About this study
Official title: Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - 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.
Read the detailed description
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.
- Being tested
- Cryotherapy, Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyBehavioural
Participants will receive cryotherapy on both hands and feet
CompressionBehavioural
Participants will receive compression on both hands and feet
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Not described Receives: Behavioral: Cryotherapy |
| Compression with Cryotherapy | Experimental | Not described Receives: Behavioral: Cryotherapy; Behavioral: Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to two months after completion of chemotherapy, an average of 6 months
Secondary outcomes (5)
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.
Measured: Up to two months after completion of chemotherapy, an average of 6 months
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".
Measured: 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
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."
Measured: Up to two months after completion of chemotherapy, an average of 6 months
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).
Measured: Up to two months after completion of chemotherapy, an average of 6 months
Chemotherapy Dose
Study staff will record the taxol dose at each cycle
Measured: Up to two months after completion of chemotherapy, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Jan 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Havrilesky, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139458
- Sponsor's protocol ID
- Pro00106236_1
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2
- ClinicalTrials.gov ID
- NCT06139458
- Acronym / sponsor ID
- Pro00106236_1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Behavioral: Cryotherapy |
| Compression with Cryotherapy | Experimental | Behavioral: Cryotherapy, Behavioral: Compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyParticipants will receive cryotherapy on both hands and feet | Behavioural | Compression with Cryotherapy, Cryotherapy |
| CompressionParticipants will receive compression on both hands and feet | Behavioural | Compression with Cryotherapy |
Primary outcome
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
Time frame: 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.
5 secondary outcomes
Tolerability of cryocompression: scale
Time frame: Up to two months after completion of chemotherapy, an average of 6 months
Acceptability: scale
Time frame: 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
Time frame: Up to two months after completion of chemotherapy, an average of 6 months
Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
Time frame: Up to two months after completion of chemotherapy, an average of 6 months
Chemotherapy Dose
Time frame: Up to two months after completion of chemotherapy, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Havrilesky principal investigator
DUHS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and Compression in people with Gynecologic Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelia Scott (919-613-4584, amelia.lorenzo@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time (time frame: Up to two months after completion of chemotherapy, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.