Use of Probiotics in preventing Side Effects of Radiotherapy in Patients of Oral and Pelvic Cancers.

A Randomized Placebo Controlled Trial of Probiotics to Reduce the Severity of Mucositis Induced by Concurrent Chemoradiotherapy (CCRT) in Patients of Head & Neck and Pelvic Malignancies.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/043515

Enrollment

200

Registered

2022-06-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C21- Malignant neoplasm of anus and anal canal Health Condition 2: C53- Malignant neoplasm of cervix uteri Health Condition 3: C18- Malignant neoplasm of colon Health Condition 4: C54- Malignant neoplasm of corpus uteri Health Condition 5: C61- Malignant neoplasm of prostate Health Condition 6: C19- Malignant neoplasm of rectosigmoidjunction Health Condition 7: C20- Malignant neoplasm of rectum Health Condition 8: C55- Malignant neoplasm of uterus, partunspecified Health Cond

Interventions

Intervention1: Probiotics: A combination of Bifidobacterium longum, Lactobacillus acidophilus and Saccharomyces boulardii. One capsule twice a day, along with radiation treatment, daily, without break

Eligibility

Inclusion criteria

Inclusion criteria: 1.Biopsy proven cases of Head & Neck Cancers (HNCs) and pelvic malignancies including Carcinoma Cervix, Carcinoma Urinary Bladder & Carcinoma Anorectum 2.Age >=18 years 3.Karnofsky Performance Status (KPS) > 60% 4.No prior mucositis 5.No prior history of chemo/radiotherapy administration 6.No prior probiotics and/or antibiotics intake (at least within preceding 15 days) study)

Exclusion criteria

Exclusion criteria: 1.Patients who refuse to give their consent 2.Serious co-morbid diseases 3.Prostate and colon malignancies (different treatment modalities) 4.History of any prior cancer, or coexisting tumors (2nd primaries) 5.Prior treatment history (Chemo/radiotherapy/surgery) 6.Patients with Immunity diseases (Autoimmunity/ Immunodeficiency) 7.Inability to take medicine orally or absorb medicine in GIT 8.Allergy to probiotics.

Design outcomes

Primary

Measure	Time frame
Use of probiotics will decrease in grade of mucositis both for head & neck cancer patients (oral, pharyngeal mucositis) and in patients of carcinoma cervix, bladder and rectal malignancies (intestinal mucositis).Timepoint: The Decrease in grade of mucositis will be assessed as follows; 1. Before the commencement of radiation treatment (baseline). 2. Two weeks after the commencement of radiation treatment. 3. Four weeks after the commencement of radiation treatment. 4. At the time of completion of radiation treatment. 5. Two weeks after the completion of radiation treatment. 6. Four weeks after the completion of radiation treatment.	—

Measure

Time frame

Use of probiotics will decrease in grade of mucositis both for head & neck cancer patients (oral, pharyngeal mucositis) and in patients of carcinoma cervix, bladder and rectal malignancies (intestinal mucositis).Timepoint: The Decrease in grade of mucositis will be assessed as follows; 1. Before the commencement of radiation treatment (baseline). 2. Two weeks after the commencement of radiation treatment. 3. Four weeks after the commencement of radiation treatment. 4. At the time of completion of radiation treatment. 5. Two weeks after the completion of radiation treatment. 6. Four weeks after the completion of radiation treatment.

—

Secondary

Measure	Time frame
Use of serial culturing we will be able to know the impact of radiation on the status of flora and impact of probiotics on the status of flora.Timepoint: The status of flora will be assessed as follows; 1. Three consecutive days before the commencement of radiation treatment (baseline). 2. Third week after the commencement of radiation treatment. 3. Fifth week after the commencement of radiation treatment. 4. Seventh week after the commencement of radiation treatment. 5. Fifteen days after the completion of radiation treatment.	—

Measure

Time frame

Use of serial culturing we will be able to know the impact of radiation on the status of flora and impact of probiotics on the status of flora.Timepoint: The status of flora will be assessed as follows; 1. Three consecutive days before the commencement of radiation treatment (baseline). 2. Third week after the commencement of radiation treatment. 3. Fifth week after the commencement of radiation treatment. 4. Seventh week after the commencement of radiation treatment. 5. Fifteen days after the completion of radiation treatment.

—

Countries

India

Contacts

Public ContactMohammad Akram

Aligarh Muslim University

akramhayat@gmail.com8791385633

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026