CompletedNot Applicable

The Impact of Oral Cryotherapy and Chewing Gum Interventions

Turkey (Türkiye)135 participantsStarted 2021-06-01

Plain-language 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. 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.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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), * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Chemotherapy-Induced Taste Alteration Scale (CITAS)

Timeframe: 18 months

Trial details

NCT IDNCT07145320

SponsorHacettepe University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-01

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