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 range18 Years – 65 Years

SexFEMALE

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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.

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