Gynecologic CancerNCT04563130
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer
A study testing Cryocompression in people with Gynecologic Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Duke University at 1 site in United States.
Trial summary
The aim of this study is to evaluate the effect of cryocompression therapy on the incidence and degree of taxane-induced peripheral neuropathy in gynecologic cancer patients receiving chemotherapy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Cryocompression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 26 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, 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 Duke Cancer Institute. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
- ECOG performance status of 0-1
- Latex allergy does not exclude a subject from the study. Non-latex gloves will be provided.
Who cannot join
- Treated with prior neurotoxic chemotherapeutic agents
- Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or associated with conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial
The aim of this study is to evaluate the effect of cryocompression therapy on the incidence and degree of taxane-induced peripheral neuropathy in gynecologic cancer patients receiving chemotherapy. Subjects will serve as their own controls, and will be randomized to cryocompression therapy on their dominant versus non-dominant hand and foot, with standard of care treatment (no intervention) on the opposite hand and foot. Compression therapy will be performed using commercially available compression socks and disposable surgical gloves, and cryotherapy will be achieved by applying bags of ice to the compression devices. Subjects will complete baseline neuropathy surveys including the Patient Neurotoxicity Questionnaire (PNQ) and the Functional Assessment of Cancer Therapy (FACT) -Taxane (FACT-NTX), which includes the sensory subscale of the FACT-NTX. Subjective symptoms will be assessed at baseline, before each cycle of chemotherapy and cryocompression, and one month after completion of 6 cycles. In addition, tactile sensation will be assessed with the monofilament test at baseline and one month after completion of 6 cycles of chemotherapy and cryocompression. The primary outcomes are the proportion of patients with PNQ grade C or higher and decline in tactile sensitivity from baseline based on the monofilament test. The investigators hypothesize that cryocompression will reduce chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer.
- Being tested
- Cryocompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryocompressionBehavioural
Cryocompression will be administered using ice bags and compression socks/ surgical gloves
| Study group | Role | What they receive |
|---|---|---|
| Cryocompression | Experimental | Patients will be randomized to receive cryocompression on one hand and foot using ice bags and compression socks. Receives: Behavioral: Cryocompression |
| Control | No intervention | Patients will be randomized to receive no intervention on the opposite hand and foot. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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). The first primary outcome of this study is the proportion of patients with Patient Neurotoxicity Questionnaire (PNQ) grade C or higher peripheral sensory neuropathy any time after the baseline assessment.
Measured: baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.
Change in Semmes-Weinstein monofilament test (tactile disturbance) over time
The monofilament test is a simple, inexpensive test to assess tactile sensation and detect peripheral sensory neuropathy. Tactile perception is assessed at 10 locations on the hand and 10 locations on the foot. Patients who exhibit any decline in tactile sensitivity in response to light touch from baseline to completion of taxane treatment will be counted as events for the primary outcome assessment.
Measured: baseline, one month after completion of chemotherapy.
Secondary outcomes (3)
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: baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.
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: after each dose of paclitaxel and cryocompression
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: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start11 Jan 2021
- Primary completion17 Nov 2022
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Havrilesky, MD, MHSc, Principal investigator, Duke University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563130
- Sponsor's protocol ID
- Pro00106236
- Status last verified
- Nov 2023
- First submitted
- 16 Sep 2020
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anastasio MK, Unnithan S, Scott A, Hayes T, Shah S, Moss HA, Erkanli A, Havrilesky LJ. Cryocompression to Reduce Peripheral Neuropathy in Gynecologic Cancer: A Randomized Controlled Trial. Obstet Gynecol. 2023 Dec 1;142(6):1459-1467. doi: 10.1097/AOG.0000000000005419. Epub 2023 Oct 26.
PubMed 37883997
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. 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
- ClinicalTrials.gov ID
- NCT04563130
- Acronym / sponsor ID
- Pro00106236
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 24 Sep 2020 (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 aim of this study is to evaluate the effect of cryocompression therapy on the incidence and degree of taxane-induced peripheral neuropathy in gynecologic cancer patients receiving chemotherapy. Subjects will serve as their own controls, and will be randomized to cryocompression therapy on their dominant versus non-dominant hand and foot, with standard of care treatment (no intervention) on the opposite hand and foot. Compression therapy will be performed using commercially available compression socks and disposable surgical gloves, and cryotherapy will be achieved by applying bags of ice to the compression devices. Subjects will complete baseline neuropathy surveys including the Patient Neurotoxicity Questionnaire (PNQ) and the Functional Assessment of Cancer Therapy (FACT) -Taxane (FACT-NTX), which includes the sensory subscale of the FACT-NTX. Subjective symptoms will be assessed at baseline, before each cycle of chemotherapy and cryocompression, and one month after completion of 6 cycles. In addition, tactile sensation will be assessed with the monofilament test at baseline and one month after completion of 6 cycles of chemotherapy and cryocompression. The primary outcomes are the proportion of patients with PNQ grade C or higher and decline in tactile sensitivity from baseline based on the monofilament test. The investigators hypothesize that cryocompression will reduce chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryocompression | Experimental | Behavioral: CryocompressionPatients will be randomized to receive cryocompression on one hand and foot using ice bags and compression socks. |
| Control | No intervention | –Patients will be randomized to receive no intervention on the opposite hand and foot. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 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 Duke Cancer Institute. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
- ECOG performance status of 0-1
- Latex allergy does not exclude a subject from the study. Non-latex gloves will be provided.
Key exclusion criteria (2 listed)
- Treated with prior neurotoxic chemotherapeutic agents
- Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or associated with 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 |
|---|---|---|
| CryocompressionCryocompression will be administered using ice bags and compression socks/ surgical gloves | Behavioural | Cryocompression |
Primary outcome
Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
Time frame: baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.
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). The first primary outcome of this study is the proportion of patients with Patient Neurotoxicity Questionnaire (PNQ) grade C or higher peripheral sensory neuropathy any time after the baseline assessment.
Change in Semmes-Weinstein monofilament test (tactile disturbance) over time
Time frame: baseline, one month after completion of chemotherapy.
The monofilament test is a simple, inexpensive test to assess tactile sensation and detect peripheral sensory neuropathy. Tactile perception is assessed at 10 locations on the hand and 10 locations on the foot. Patients who exhibit any decline in tactile sensitivity in response to light touch from baseline to completion of taxane treatment will be counted as events for the primary outcome assessment.
3 secondary outcomes
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
Time frame: baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.
Tolerability of cryocompression: scale
Time frame: after each dose of paclitaxel and cryocompression
Acceptability: scale
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 37883997Anastasio MK, Unnithan S, Scott A, Hayes T, Shah S, Moss HA, Erkanli A, Havrilesky LJ. Cryocompression to Reduce Peripheral Neuropathy in Gynecologic Cancer: A Randomized Controlled Trial. Obstet Gynecol. 2023 Dec 1;142(6):1459-1467. doi: 10.1097/AOG.0000000000005419. Epub 2023 Oct 26.
- Individual participant dataSharing planned: No
Related trials for Gynecologic Cancer
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
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. This study is not recruiting at the moment.
Laura Havrilesky, MD, MHSc principal investigator
Duke University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryocompression in people with Gynecologic Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Duke University at 1 site 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 4 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: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time (time frame: baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563130, which also lists 1 linked publication.
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 13 Nov 2023.