Clinical trial · Interventional
The Impact of Oral Cryotherapy and Chewing Gum Interventions
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chewing Gum | — | UNRESOLVED | — |
| Nausea and Vomiting | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chewing Gum Group (Group 2) | Other | — | UNRESOLVED |
| Oral Cryotherapy Group (Group 1) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Oral Cryotherapy Group (Group 1)
- description
- 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.
- interventionNames
- Other: Oral Cryotherapy Group (Group 1)
- type
- EXPERIMENTAL
- label
- Chewing Gum Group (Group 2)
- description
- 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.
- interventionNames
- Other: Chewing Gum Group (Group 2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available