The Impact of Oral Cryotherapy and Chewing Gum Interventions

NCT07145320 | Completed DMC

• 1 other identifier: KA-2020-05/615
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Nausea and Vomiting; Quality of Life; Chewing Gum

Outcome Measures

Primary Outcomes (1)

• Chemotherapy-Induced Taste Alteration Scale (CITAS)

  18 months

Study Arms (3)

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.

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.

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.

Interventions

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.

Oral Cryotherapy Group (Group 1)

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.

Chewing Gum Group (Group 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 18-65
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Adnan Saygun, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Berna KURT

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All statistical analyses were carried out by an independent biostatistician blinded to group assignments to minimize bias and maintain analytical integrity.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 28, 2025
• Study Start: June 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: May 1, 2022
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)