Breast CancerNCT07145320
The Impact of Oral Cryotherapy and Chewing Gum Interventions
A study testing Oral Cryotherapy Group (Group 1) and Chewing Gum Group (Group 2) in people with Breast Cancer and Nausea and Vomiting, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Chemotherapy-induced nausea and vomiting (CINV) and taste alterations continue to be among the most common and most severe side effects that women receiving adjuvant chemotherapy for breast cancer suffer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Nausea and Vomiting, Quality of Life
- What is being tested?
- Oral Cryotherapy Group (Group 1) and Chewing Gum Group (Group 2)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 May 2022
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged between 18 and 65 years,
- Scheduled to receive adjuvant chemotherapy for the first time,
- Receiving the AC protocol as their chemotherapy regimen,
- Receiving chemotherapy doses classified as moderately emetogenic (according to the International Society of Supportive Care in Cancer Guidelines),
- Not having received radiotherapy prior to adjuvant chemotherapy,
- Without chronic diseases (coronary artery disease, chronic kidney disease, or diabetes mellitus),
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- Not having used any non-pharmacological method for nausea and vomiting,
- Diagnosed with breast cancer for the first time,
- Without metastasis,
- Without thrombocytopenia,
- At an early stage,
- Aware of their diagnosis,
- Open to communication and cooperation,
- Literate,
- Not receiving psychiatric and/or depression treatment,
- Not in the terminal stage,
- Willing and volunteering to participate in the study.
Who cannot join
- Illiterate,
- Over 65 years of age,
- Using anxiolytic or antidepressant medications,
- Having chronic diseases (gastrointestinal obstruction/disease, hepatitis, coronary artery disease, chronic kidney disease, or diabetes mellitus),
- Having metastasis,
- Having received radiotherapy prior to adjuvant chemotherapy,
- Not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Adnan Saygun, 06100
About this study
Official title: The Impact of Oral Cryotherapy and Chewing Gum Interventions on Chemotherapy-induced Acute and Anticipatory Nausea, Vomiting, and Taste Alterations in Women Receiving Treatment for Breast Cancer: A Randomized Controlled Trial
Chemotherapy-induced nausea and vomiting (CINV) and taste alterations continue to be among the most common and most severe side effects that women receiving adjuvant chemotherapy for breast cancer suffer. Despite standard antiemetic treatments, a significant proportion of patients experience inadequate symptom management, necessitating investigation into complementary non-pharmacological interventions such as oral cryotherapy and chewing gum in women undergoing Adriamycin-Cyclophosphamide therapy. 135 female patients recently diagnosed with early-stage breast cancer participated in a single-center, three-arm randomized controlled trial. Random assignment was used to assign participants to the oral cryotherapy group (OCG), chewing gum group (CGG), or control group (CG). Interventions were used during the initial cycle of chemotherapy.
Read the detailed description
Chemotherapy-induced nausea and vomiting (CINV) remains one of the most distressing and prevalent side effects of cancer treatment, affecting a substantial proportion of patients undergoing chemotherapy. Despite advances in antiemetic regimens, CINV continues to occur in many patients, significantly impairing their quality of life and clinical outcomes. The onset and severity of CINV are largely influenced by the emetogenic potential of chemotherapeutic agents, with drugs such as cyclophosphamide and doxorubicin frequently triggering acute symptoms within the first 1-5 days post-administration.
CINV is a multifactorial process involving both peripheral and central pathways. Cytotoxic agents stimulate the release of serotonin from enterochromaffin cells in the gastrointestinal tract, which subsequently activates 5-hydroxytryptamine 3 (5-HT₃) receptors in the chemoreceptor trigger zone (CTZ) of the central nervous system, leading to emesis. The CTZ, located in the area postrema of the medulla oblongata, is particularly vulnerable due to its lack of a complete blood-brain barrier, facilitating the access of circulating emetogenic substances. Beyond the immediate physical discomfort, poorly managed CINV contributes to complications including malnutrition, dehydration, electrolyte imbalances, metabolic disturbances, increased infection risk, and significant psychological distress. These complications often necessitate additional medical interventions and hospitalizations, increasing the financial and emotional burden on patients, caregivers, and healthcare systems. Despite routine pharmacologic interventions, many patients continue to experience CINV, which points to the importance of effective, accessible, and patient-centered non-pharmacologic approaches. Oral cryotherapy, localized cooling of the oral mucosa via ice application, has gained attention as a low-cost, well-tolerated method primarily used to prevent chemotherapy-induced oral mucositis. This method induces vasoconstriction of oral blood vessels during intravenous chemotherapy infusion, thereby limiting drug delivery to oral tissues. Although cryotherapy has been explored in other contexts, such as surgical nausea and gynecological care, its potential for CINV management remains underinvestigated. Another promising non-pharmacologic intervention is chewing gum, which stimulates salivary flow and may help mitigate the oral side effects of chemotherapy. Saliva has intrinsic protective and antimicrobial properties, and its production may be reduced by chemotherapy-induced cytotoxicity on salivary glands.
- Conditions
- Breast Cancer, Nausea and Vomiting, Quality of Life, Chewing Gum
- Being tested
- Oral Cryotherapy Group (Group 1), Chewing Gum Group (Group 2)
- Medical subject headings
- Breast Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Cryotherapy Group (Group 1)Other
Participants were educated about oral cryotherapy before their first chemotherapy cycle. Individually portioned ice bags (15 mL per cube) were prepared and provided free of charge for home use (6 bags per cycle). Patients were instructed to apply the ice intra-orally for 30 minutes at a time, 6-10 times daily, beginning at the start of Adriamycin infusion. A Cryotherapy Application Log Form was used to record date, start, and end times for each session.
Chewing Gum Group (Group 2)Other
Patients received standardized, tasteless, single-use chewing gum (6 boxes per cycle) and were instructed to chew a piece for 20-30 minutes before and during chemotherapy infusion. A new piece was provided midway through the session. Usage was recorded in a Chewing Gum Application Log Form, capturing date and timing details.
| Study group | Role | What they receive |
|---|---|---|
| Oral Cryotherapy Group (Group 1) | Experimental | Participants were educated about oral cryotherapy before their first chemotherapy cycle. Individually portioned ice bags (15 mL per cube) were prepared and provided free of charge for home use (6 bags per cycle). Patients were instructed to apply the ice intra-orally for 30 minutes at a time, 6-10 times daily, beginning at the start of Adriamycin infusion. A Cryotherapy Application Log Form was used to record date, start, and end times for each session. Receives: Other: Oral Cryotherapy Group (Group 1) |
| Chewing Gum Group (Group 2) | Experimental | Patients received standardized, tasteless, single-use chewing gum (6 boxes per cycle) and were instructed to chew a piece for 20-30 minutes before and during chemotherapy infusion. A new piece was provided midway through the session. Usage was recorded in a Chewing Gum Application Log Form, capturing date and timing details. Receives: Other: Chewing Gum Group (Group 2) |
| Control Group (Group 3) | No intervention | Patients in the control group received routine clinical care and antiemetic treatment per protocol, with no additional interventions. Upon study completion, educational brochures and informational materials regarding oral cryotherapy and chewing gum interventions were provided to the control group to mitigate potential bias and ensure equitable access to relevant information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy-Induced Taste Alteration Scale (CITAS)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Jun 2021
- Primary completion1 Jul 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Model description
- This study employed a prospective, randomized controlled trial (RCT) design with three parallel arms to evaluate the efficacy of two non-pharmacologic interventions in managing chemotherapy-induced symptoms.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna KURT, Hacettepe University
- Investigators
- Berna KURT, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145320
- Sponsor's protocol ID
- KA-2020-05/615
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Oral Cryotherapy and Chewing Gum Interventions on Chemotherapy-induced Acute and Anticipatory Nausea, Vomiting, and Taste Alterations in Women Receiving Treatment for Breast Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07145320
- Acronym / sponsor ID
- KA-2020-05/615
- Conditions
- Breast Cancer, Nausea and Vomiting, Quality of Life, Chewing Gum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 28 Aug 2025 (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.
Chemotherapy-induced nausea and vomiting (CINV) and taste alterations continue to be among the most common and most severe side effects that women receiving adjuvant chemotherapy for breast cancer suffer. Despite standard antiemetic treatments, a significant proportion of patients experience inadequate symptom management, necessitating investigation into complementary non-pharmacological interventions such as oral cryotherapy and chewing gum in women undergoing Adriamycin-Cyclophosphamide therapy. 135 female patients recently diagnosed with early-stage breast cancer participated in a single-center, three-arm randomized controlled trial. Random assignment was used to assign participants to the oral cryotherapy group (OCG), chewing gum group (CGG), or control group (CG). Interventions were used during the initial cycle of chemotherapy.
Detailed description
Chemotherapy-induced nausea and vomiting (CINV) remains one of the most distressing and prevalent side effects of cancer treatment, affecting a substantial proportion of patients undergoing chemotherapy. Despite advances in antiemetic regimens, CINV continues to occur in many patients, significantly impairing their quality of life and clinical outcomes. The onset and severity of CINV are largely influenced by the emetogenic potential of chemotherapeutic agents, with drugs such as cyclophosphamide and doxorubicin frequently triggering acute symptoms within the first 1-5 days post-administration.
CINV is a multifactorial process involving both peripheral and central pathways. Cytotoxic agents stimulate the release of serotonin from enterochromaffin cells in the gastrointestinal tract, which subsequently activates 5-hydroxytryptamine 3 (5-HT₃) receptors in the chemoreceptor trigger zone (CTZ) of the central nervous system, leading to emesis. The CTZ, located in the area postrema of the medulla oblongata, is particularly vulnerable due to its lack of a complete blood-brain barrier, facilitating the access of circulating emetogenic substances. Beyond the immediate physical discomfort, poorly managed CINV contributes to complications including malnutrition, dehydration, electrolyte imbalances, metabolic disturbances, increased infection risk, and significant psychological distress. These complications often necessitate additional medical interventions and hospitalizations, increasing the financial and emotional burden on patients, caregivers, and healthcare systems. Despite routine pharmacologic interventions, many patients continue to experience CINV, which points to the importance of effective, accessible, and patient-centered non-pharmacologic approaches. Oral cryotherapy, localized cooling of the oral mucosa via ice application, has gained attention as a low-cost, well-tolerated method primarily used to prevent chemotherapy-induced oral mucositis. This method induces vasoconstriction of oral blood vessels during intravenous chemotherapy infusion, thereby limiting drug delivery to oral tissues. Although cryotherapy has been explored in other contexts, such as surgical nausea and gynecological care, its potential for CINV management remains underinvestigated. Another promising non-pharmacologic intervention is chewing gum, which stimulates salivary flow and may help mitigate the oral side effects of chemotherapy. Saliva has intrinsic protective and antimicrobial properties, and its production may be reduced by chemotherapy-induced cytotoxicity on salivary glands.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This study employed a prospective, randomized controlled trial (RCT) design with three parallel arms to evaluate the efficacy of two non-pharmacologic interventions in managing chemotherapy-induced symptoms.
| Arm | Type | Receives |
|---|---|---|
| Oral Cryotherapy Group (Group 1) | Experimental | Other: Oral Cryotherapy Group (Group 1)Participants were educated about oral cryotherapy before their first chemotherapy cycle. Individually portioned ice bags (15 mL per cube) were prepared and provided free of charge for home use (6 bags per cycle). Patients were instructed to apply the ice intra-orally for 30 minutes at a time, 6-10 times daily, beginning at the start of Adriamycin infusion. A Cryotherapy Application Log Form was used to record date, start, and end times for each session. |
| Chewing Gum Group (Group 2) | Experimental | Other: Chewing Gum Group (Group 2)Patients received standardized, tasteless, single-use chewing gum (6 boxes per cycle) and were instructed to chew a piece for 20-30 minutes before and during chemotherapy infusion. A new piece was provided midway through the session. Usage was recorded in a Chewing Gum Application Log Form, capturing date and timing details. |
| Control Group (Group 3) | No intervention | –Patients in the control group received routine clinical care and antiemetic treatment per protocol, with no additional interventions. Upon study completion, educational brochures and informational materials regarding oral cryotherapy and chewing gum interventions were provided to the control group to mitigate potential bias and ensure equitable access to relevant information. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Women aged between 18 and 65 years,
- Scheduled to receive adjuvant chemotherapy for the first time,
- Receiving the AC protocol as their chemotherapy regimen,
- Receiving chemotherapy doses classified as moderately emetogenic (according to the International Society of Supportive Care in Cancer Guidelines),
- Not having received radiotherapy prior to adjuvant chemotherapy,
Key exclusion criteria (7 listed)
- Illiterate,
- Over 65 years of age,
- Using anxiolytic or antidepressant medications,
- Having chronic diseases (gastrointestinal obstruction/disease, hepatitis, coronary artery disease, chronic kidney disease, or diabetes mellitus),
- Having metastasis,
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 |
|---|---|---|
| Oral Cryotherapy Group (Group 1)Participants were educated about oral cryotherapy before their first chemotherapy cycle. Individually portioned ice bags (15 mL per cube) were prepared and provided free of charge for home use (6 bags per cycle). Patients were instructed to apply the ice intra-orally for 30 minutes at a time, 6-10 times daily, beginning at the start of Adriamycin infusion. A Cryotherapy Application Log Form was used to record date, start, and end times for each session. | Other | Oral Cryotherapy Group (Group 1) |
| Chewing Gum Group (Group 2)Patients received standardized, tasteless, single-use chewing gum (6 boxes per cycle) and were instructed to chew a piece for 20-30 minutes before and during chemotherapy infusion. A new piece was provided midway through the session. Usage was recorded in a Chewing Gum Application Log Form, capturing date and timing details. | Other | Chewing Gum Group (Group 2) |
Primary outcome
Chemotherapy-Induced Taste Alteration Scale (CITAS)
Time frame: 18 months
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 28 Aug 2025.
- Individual participant dataSharing planned: No. will be shared upon request
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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. This study is not recruiting at the moment.
Berna KURT principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Cryotherapy Group (Group 1) and Chewing Gum Group (Group 2) in people with Breast Cancer and Nausea and Vomiting, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 17 inclusion and 7 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 28 Aug 2025. 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 Turkey (Türkiye). 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?
Chemotherapy-Induced Taste Alteration Scale (CITAS) (time frame: 18 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 28 Aug 2025.