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The Impact of Oral Cryotherapy and Chewing Gum Interventions

NCT07145320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Berna KURT · Hacettepe University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-07-01
Completion
2022-05-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145320 on ClinicalTrials.gov