Clinical trial NCT05348239: Chlorophyllin Tablets for Urinary Bleeding Following Radiation Therapy for Cancers of Pelvic Organs
Official title: A Phase II Study to Evaluate Oral Chlorophyllin in Hemorrhagic Cystitis Secondary to Radiation Therapy for Pelvic Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hemorrhagic Cystitis
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
Collaborators: name: Bhabha Atomic Research Centre (BARC), Mumbai
First posted: 2022-04-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, single centre, single-arm, interventional phase II study.
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.

Detailed description: Radiation therapy to the pelvis is a commonly used treatment modality for urological, gynaecological and rectal cancers. Intensity modulation and image guidance have improved the delivery of radiation therapy in recent times. However, this does not eliminate the risk of radiation-induced damage to the adjacent healthy tissue - in this consideration, the bladder. Hemorrhagic cystitis accounts for 5-7% of emergency urology admissions. The procedure for the management of radiation cystitis proceeds from non-invasive oral drugs and HBOT to minimally invasive treatment like intravesical therapy and angioembolization, to more morbid procedures like cystectomy and urinary diversion. Although these treatment modalities have shown some success, most patients continue to have recurrent/persistent hematuria. There is a need to explore options of other oral/intravesical agents which can aid in mucosal healing and stop hematuria with lasting effects. Sodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from green plant pigment, chlorophyll. It is a semi-synthetic mixture of sodium copper salts derived from chlorophyll. Chlorophyllin scavenges radiation-induced free radicals and reactive oxygen species. Research at BARC has shown that chlorophyllin prevents radiation-induced toxicity in normal hematopoietic tissues and normal epithelial cells. A phase 1 clinical study in healthy volunteers indicate that CHL is safe and tolerable in humans and has not shown any severe adverse events. The purpose of this study is to evaluate the safety and efficacy of oral sodium copper chlorophyllin in hemorrhagic cystitis secondary to radiation therapy for pelvic malignancy.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age with a history of radiotherapy for pelvic malignancy in the past more than 3 months back.
* Any grade of radiation-induced cystitis as per RTOG criteria (RTOG Grade 1-4 equivalent to CTCAE Grade 1-3).
* Adequate liver function defined as ALT/ALT ≤ 3 times ULN and total bilirubin ≤ 2 times ULN. Elevated transaminases up to 5 times ULN is allowed in patients with liver metastasis.
* Adequate renal function defined as creatine clearance ≥ 30 mL/min (By Cockcroft-Gault formula).

Exclusion Criteria:

* Known hypersensitivity or contraindications against sodium chlorophyllin.
* Hemodynamically unstable patients not responding to initial resuscitation.
* Patients with life-threatening hemorrhagic cystitis requiring urgent invasive intervention (CTCAE grade 4).

Primary outcomes:
measure: Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
timeFrame: Baseline
measure: Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
timeFrame: Post 1 month
measure: Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
timeFrame: Post 3 months
measure: Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
timeFrame: Post 6 months
Secondary outcomes:
measure: Assessment of Bladder Cancer Index (BCI) scores.
timeFrame: Baseline, post 1 month, post 3 months
measure: Assessment of Treatment Failure (TF).
timeFrame: Post 3 months
measure: Evaluation of treatment failure-free survival.
timeFrame: Baseline to up to 3 months
measure: Assessment of Quality of Life (QOL) using EORTC -QLQ C-30 questionnaire.
timeFrame: Baseline, post 1 month, post 3 months
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Maharashtra
Study officials:
affiliation: Tata Memorial Centre
name: Dr. Gagan Prakash
role: PRINCIPAL_INVESTIGATOR
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