Cryocompression for Gynecologic Cancer

Recruiting at 1 trial location

Overseen By Mary K Anastasio

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Paclitaxel

Disqualifiers: Peripheral neuropathy, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

190 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cryocompression for Gynecologic Cancer?

Research shows that compression therapy can help manage swelling in conditions like lymphedema, which is common after gynecologic cancer treatment. Although specific data on cryocompression for gynecologic cancer is limited, compression therapy has been effective in reducing limb swelling in other cancer-related conditions. ^{1 2 3 4 5}

Is cryocompression therapy safe for humans?

Cryocompression therapy is generally safe, but there are some risks. Whole-body cryotherapy has been associated with a few adverse events, but these are within acceptable limits if guidelines are followed. However, there is a report of severe hypothermic injury from continuous cryocompression therapy, highlighting the importance of careful use. ^{6 7 8 9 10}

How does cryocompression for gynecologic cancer differ from other treatments?

Cryocompression is unique because it combines cryotherapy (using extreme cold to destroy abnormal tissue) with compression, which may enhance the effectiveness of the treatment by improving blood flow and reducing swelling. This approach is different from traditional treatments that typically use surgery, radiation, or chemotherapy alone. ^{11 12 13 14 15}

Research Team

Laura Havrilesky

Principal Investigator

DUHS

Eligibility Criteria

This trial is for patients with gynecologic cancers (like ovarian, cervical, endometrial) who are set to receive at least 6 cycles of paclitaxel chemotherapy every 3 weeks. They should be in good physical condition as indicated by an ECOG score of 0-1. Those with previous treatments that can affect nerves or existing conditions like diabetic neuropathy aren't eligible.

Inclusion Criteria

I am fully active or can carry out light work.

I have been diagnosed with a type of gynecologic cancer.

I plan to undergo chemotherapy with paclitaxel for at least 6 cycles at a specified location.

Exclusion Criteria

I have been diagnosed with a condition like diabetic neuropathy or fibromyalgia.

I have been treated with chemotherapy that can affect the nerves.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryotherapy wraps plus compression therapy or cryotherapy wraps alone during their taxane infusions

6 months

Visits at each chemotherapy session

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of neuropathy and tolerability

2 months

Treatment Details

Interventions

• Compression
• Cryotherapy

Trial Overview The study is testing if using cryotherapy wraps with compression therapy (cryocompression) is as effective as cryotherapy alone in reducing nerve pain and damage caused by chemotherapy in gynecologic cancer patients. It also evaluates patient comfort and satisfaction with the treatment.

Participant Groups

Group I: Cryotherapy Experimental Treatment 1 Intervention

Group II: Compression with Cryotherapy Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

A study involving 1,034 patients with lower limb lymphedema (LLL) after gynecological cancer treatment found that factors like age, body mass index (BMI), type of cancer, and previous radiotherapy significantly influenced the effectiveness of compression-based physical therapy (CPT).

Patients with a BMI of 28 kg/m² or higher who had received radiation therapy showed a poor response to CPT, indicating that these factors may help predict which patients are less likely to benefit from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with response to compression-based physical therapy for secondary lower limb lymphedema after gynecologic cancer treatment: a multicenter retrospective study. Yoshihara, M., Kitamura, K., Tsuru, S., et al.[2022]

Compression therapy is essential for treating venous and lymphatic disorders, but challenges like poor patient compliance and application difficulties in the elderly limit its effectiveness.

Innovative approaches, including four-layer bandages and new textile technologies, may improve the application of compression therapy, especially in complex cases like leg ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compression therapy. Ramelet, AA.[2022]

Compression therapy is effective for treating swollen extremities, but its success varies based on factors like the underlying condition, the amount of pressure applied, body position, and the type of compression material used.

Understanding these factors is crucial for optimizing compression therapy to achieve the best outcomes for patients with swelling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compression therapy of the legs. A review. Partsch, H.[2019]

Compression therapy significantly reduces the morbidity of lymphedema in breast cancer patients, as shown by a meta-analysis of 17 studies, indicating it is an effective treatment option.

While compression therapy improves shoulder range of motion, its effect on limb volume remains unclear and requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compression Therapy for the Patients With Breast Cancer: A Meta-analysis of Randomized Controlled Trials. Li, JX., Gao, J., Song, JY., et al.[2022]

In a pilot study involving 56 gynecological cancer patients, the use of customized compression garments (CG) for 6 weeks showed a lower incidence of lower limb lymphedema (LLL) at 7.7% compared to 13.3% in the control group, although this difference was not statistically significant.

The study suggests that while CG may help reduce the risk of LLL when combined with patient education, further research with a larger sample size is needed to confirm these findings, as compliance was high and quality of life scores were similar in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does initial routine use of a compression garment reduce the risk of lower limb lymphedema after gynecological cancer treatment? A randomized pilot study in an Asian institution and review of the literature. Hnin, YK., Ong, LX., Tsai, CC., et al.[2019]

Cryotherapy for treating precancerous cervical lesions has shown high cure rates, ranging from 56.8% to 96.6% in controlled trials, and is well-accepted by patients due to its low complication rates and manageable side effects.

This treatment is particularly advantageous in low-resource settings because it is affordable and can be easily integrated into existing cervical cancer screening and treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, acceptability and affordability of cryotherapy: a review of current literature. McClung, EC., Blumenthal, PD.[2012]

A prototype gas conditioner for cryotherapy was developed and tested, showing a significant reduction in equipment blockage during treatment, with a 0% blockage rate when using the device alone compared to higher rates with other methods.

Field reports from users in Peru and Kenya were positive, indicating that this device could effectively prevent operational failures in cryotherapy, making it a promising solution for low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary report of a gas conditioner to improve operational reliability of cryotherapy in developing countries. Seamans, Y., Sellors, J., Broekhuizen, F., et al.[2018]

Whole-body cryotherapy (WBC) has shown potential benefits for improving sleep quality, enhancing recovery after exercise, and alleviating chronic pain, with some evidence suggesting positive effects on mental health and cognitive functions due to increased BDNF levels.

Despite some safety concerns raised by health authorities regarding adverse events, a review of the literature indicates that the risks associated with true WBC are manageable and can be minimized by following established guidelines and recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating safety risks of whole-body cryotherapy/cryostimulation (WBC): a scoping review from an international consortium. Legrand, FD., Dugué, B., Costello, J., et al.[2023]

In a study involving 10 healthy subjects, ice treatment resulted in the greatest reduction in muscle temperature compared to Game Ready (GR) systems, with medium and high compression providing better cooling than no compression.

All cryotherapy methods caused acute increases in cardiovascular strain, but these increases were not greater than those experienced during exercise, indicating that the cardiovascular response to cryotherapy is manageable and similar to normal physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cold modality application with static and intermittent pneumatic compression on tissue temperature and systemic cardiovascular responses. Holwerda, SW., Trowbridge, CA., Womochel, KS., et al.[2021]

A rare case of iatrogenic hypothermic injury occurred in a patient after using cryocompression therapy for an ankle fracture, leading to significant soft tissue damage including skin epidermolysis and partial nerve damage.

This incident highlights the potential risks associated with cryocompression therapy, which is commonly used for pain and swelling, suggesting that careful monitoring is necessary to prevent hypothermic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe hypothermic injury to the foot and ankle caused by continuous cryocompression therapy. Høiness, PR., Hvaal, K., Engebretsen, L.[2005]

Cryosurgery was successfully used to treat an advanced epidermoid carcinoma of the vulva in an elderly patient who refused radical surgery, demonstrating its potential as a viable treatment option.

The procedure was well tolerated by the patient, who had underlying health issues, and it achieved local tumor control, suggesting that cryosurgery can be a safe and effective alternative for patients unable to undergo more invasive surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryosurgery of advanced vulvar carcinoma. Wallach, RC.[2009]

Uninterrupted cryotherapy using nitrous oxide (N2O) and carbon dioxide (CO2) effectively achieved tissue temperatures below -20 degrees Celsius, which is necessary for treating cervical precancer.

The CO2 cryotherapy methods using the cough technique did not reach the required low temperatures, suggesting that this approach may be less effective and highlighting the need for better methods to prevent gas blockage during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cough technique and cryogen gas on temperatures achieved during simulated cryotherapy. Seamans, Y., Loesel, C., Jeronimo, J., et al.[2022]

Cryotherapy has been successfully applied in 440 procedures across 393 patients, demonstrating its effectiveness in gynecological treatments.

This technique is particularly useful for treating conditions such as acute condylomas and for both palliative and curative therapies for vulvar carcinomas, expanding the options available for medical care in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recommendations for the use of cryotherapy in gynecology]. Renziehausen, K.[2008]

In a study comparing single and double freeze cryotherapy on the cervices of women undergoing hysterectomy, the double freeze technique resulted in significantly deeper tissue necrosis, indicating potentially greater effectiveness in treating cervical premalignant lesions.

The study highlights the advantages of cryotherapy as a low-cost, electricity-free treatment option for cervical lesions, making it particularly suitable for low-resource settings where cervical cancer rates are high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the depth of tissue necrosis between double-freeze and single-freeze nitrous oxide-based cryotherapy. Adepiti, AC., Ajenifuja, OK., Fadahunsi, OO., et al.[2018]

The cryosurgery device, used over 3 years, has effectively treated both benign and malignant conditions of the vulva, vagina, and cervix, demonstrating its clinical value.

Liquid nitrogen is utilized as a cooling agent, allowing for both 'spray' and 'contact-freezing' techniques, while protective tubes made of Teflon and Polyurethane foam successfully prevent damage to surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cryogenic therapy device for use in gynecology]. Renziehausen, K., Krantz, H.[2008]

References

1. England pubmed.ncbi.nlm.nih.gov

Factors associated with response to compression-based physical therapy for secondary lower limb lymphedema after gynecologic cancer treatment: a multicenter retrospective study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Compression therapy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Compression therapy of the legs. A review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Compression Therapy for the Patients With Breast Cancer: A Meta-analysis of Randomized Controlled Trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Does initial routine use of a compression garment reduce the risk of lower limb lymphedema after gynecological cancer treatment? A randomized pilot study in an Asian institution and review of the literature. [2019]

6. Italy pubmed.ncbi.nlm.nih.gov

Efficacy, safety, acceptability and affordability of cryotherapy: a review of current literature. [2012]

7. England pubmed.ncbi.nlm.nih.gov

Preliminary report of a gas conditioner to improve operational reliability of cryotherapy in developing countries. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Evaluating safety risks of whole-body cryotherapy/cryostimulation (WBC): a scoping review from an international consortium. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of cold modality application with static and intermittent pneumatic compression on tissue temperature and systemic cardiovascular responses. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Severe hypothermic injury to the foot and ankle caused by continuous cryocompression therapy. [2005]

11. United States pubmed.ncbi.nlm.nih.gov

Cryosurgery of advanced vulvar carcinoma. [2009]

12. England pubmed.ncbi.nlm.nih.gov

Effect of cough technique and cryogen gas on temperatures achieved during simulated cryotherapy. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

[Recommendations for the use of cryotherapy in gynecology]. [2008]

14. Nigeria pubmed.ncbi.nlm.nih.gov

Comparison of the depth of tissue necrosis between double-freeze and single-freeze nitrous oxide-based cryotherapy. [2018]

15. Germany pubmed.ncbi.nlm.nih.gov

[Cryogenic therapy device for use in gynecology]. [2008]